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A Study in Relapse Prevention of Treatment-Resistant Depression

Primary Purpose

Treatment Resistant Depression

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Olanzapine and Fluoxetine combination (OFC)

Fluoxetine

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have single or recurrent unipolar Major Depressive Disorder (MDD), without psychotic features by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) clinical assessment, confirmed by the structured clinician Interview for DSM-IV Axis 1 disorders (SCID-I).
If female and of childbearing potential, test negative for pregnancy and agree to abstain from sexual activity or use a medically accepted means of contraception during the study. Use of any oral or injectable contraception must be initiated prior to receiving treatment.
Have 17-item Hamilton Depression (HAM-D) score greater than or equal to 18 at screening and the day treatment is due to be received for the first time.
Have treatment-resistant depression, as defined by having demonstrated failure to achieve satisfactory antidepressant response to adequate separate treatment courses of at least 2 different antidepressants within the current episode of MDD.

Exclusion Criteria:

Have a diagnosis of Parkinson's disease or related disorders.
Have a current or lifetime diagnosis of any of the following according to DSM-IV criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Bipolar Disorder I or II, Delirium of any type, Dementia of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition.
Have current diagnosis of post-partum depression, MDD with atypical features, or MDD with a seasonal pattern as defined in the DSM-IV.
Have paranoid, schizoid, schizotypal, antisocial, and borderline personality disorders (Axis II) as a comorbid or primary diagnosis, based on DSM-IV criteria.
Have had psychotic symptoms within 1 month prior to Screening or demonstrate psychotic features at screening and on the day treatment is due to be assigned for the first time as determined by the investigator.
Have DSM-IV substance dependence/abuse or not willing to avoid use of the substance (not including dependence on nicotine or caffeine), as defined by the SCID-I, within the past 30 days.
Are actively suicidal in the judgment of the investigator.
Have had one or more seizures without a clear and resolved etiology.
Have leukopenia or history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the participant's lifetime.
Have alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) values greater than or equal to 2 times the ULN or total bilirubin values greater than or equal to 1.5 times the ULN at any time during screening.
Have acute, serious, or unstable medical conditions.
Have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 6 months.
Have elevated prolactin levels at screening.
Have Bazett's corrected QT interval (QTc) greater than 450 milliseconds (male) or greater than 470 milliseconds (female) at screening and when treatment is due to be received for the first time.
Have received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) treatment within the current episode; have a history of failure to adequate treatment courses of ECT or VNS; or will require ECT or VNS at any time during study participation.
If receiving psychotherapy, light therapy, or both, are anticipated to require changes in frequency/intensity of treatment regimen or to cease treatment regimen over the duration of the study. Participants who are not receiving any of these therapies upon study entry may not begin any of these therapies during screening, or during any treatment phases of the study.
Have received previous treatment with clozapine.
Have used a monoamine oxidase inhibitor (MAOI) within 14 days prior to screening or are expected to need MAOI treatment at any time during this study through 5 weeks after the participant discontinues from the study.

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olanzapine and Fluoxetine combination (OFC)

Fluoxetine

Arm Description

Outcomes

Primary Outcome Measures

Time to Relapse by Any Criteria

Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation.

Secondary Outcome Measures

Percentage of Participants Who Relapse by Any Criteria

Relapse is defined as meeting any of the following criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.

Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score

Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill).

Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality

Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality

Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.

Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score

Time to Relapse as Measured by Hospitalization for Depression or Suicidality

Those who did not relapse were "censored" at their last observation.

Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality

Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase

A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).

Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase

Percentage of Participants Achieving Remission at Any Point During Stabilization Treatment Phase

Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

Percentage of Participants Maintaining Remission

Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Mixed-Effects Model Repeated Measures (MMRM) Analysis

The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.

Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Last Observation Carried Forward (LOCF) Analysis

Mean Change From Week 20 to Week 47 in Clinical Global Impressions - Severity (CGI-S) of Depression Using Mixed-Effects Model Repeated Measures (MMRM) Analysis

CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.

Resource Utilization - Average Number of Hours Worked for Pay Per Week at Week 47

Resource Utilization (Number of Psychiatric Visits, Number of Emergency Room or Equivalent Facility Visits for Psychiatric Illness)

Resource utilization is defined as the average number of psychiatric visits and number of emergency room or equivalent facility visits for psychiatric illness.

Change From Week 20 to Week 47 Endpoint in the Sheehan Disability Scale (SDS)

The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work or school (Item 1), social (Item 2), and family life and home responsibilities (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.

Percent of Participants With Treatment-Emergent Akathisia

Barnes Akathisia Scale (BAS) rates observable, restless movements of drug-induced akathisia as well as the subjective awareness of restlessness and any distress associated with the akathisia. It consists of 4 items. 3 items (objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness) rated on a 4-point scale, with 0 being no akathisia and 3 being severe akathisia. Item 4 (global clinical assessment of Akathisia) is derived from the responses on Items 1-3 rated on a 6-point scale, with 0 being absence and 5 being extreme Akathisia. Treatment emergent akathisia is defined as a global clinical assessment score on BAS <2 at baseline (Week 20) and a global clinical assessment score on BAS ≥2 post-baseline (Weeks 21-47).

Percent of Participants With Treatment-Emergent Parkinsonism

Simpson-Angus Scale is used to measure Parkinsonian-type symptoms in participants exposed to neuroleptics. The scale consists of 10 items, each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items and ranges from 0-40 with higher scores indicating worse conditions. Treatment emergent parkinsonism is defined as total score ≤3 of items 1 through 10 of the Simpson-Angus scale at baseline (Week 20) and a total score >3 of items 1 through 10 post-baseline (Weeks 21-47).

Percent of Participants With Treatment-Emergent Dyskinesia

Abnormal Involuntary Movement Scale (AIMS) is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of the participants. Treatment emergent dyskinesia is defined as a score ≥3 on any one of the AIMS items 1-7 post-baseline (Weeks 21-47) or scores ≥2 on any two of the AIMS items 1-7 post-baseline (Weeks 21-47) among participants without either criteria at baseline (Week 20).

Mean Change From Week 20 to Week 47 in Fasting Total Cholesterol

Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.

Percent of Participants With Treatment-Emergent High Fasting Total Cholesterol

Borderline to High fasting total cholesterol: ≥200 milligrams/deciliter (mg/dL) and <240 mg/dL at baseline and ≥240 mg/dL any time post baseline; Normal to Borderline fasting total cholesterol: <200 mg/dL at baseline, ≥200 mg/dL and <240 mg/dL any time post baseline; Normal to High fasting total cholesterol: <200 mg/dL at baseline and ≥240 mg/dL any time post baseline.

Mean Change From Week 20 to Week 47 in Fasting Low-Density Lipoprotein (LDL) Cholesterol

Percent of Participants With Treatment-Emergent High Fasting Low-Density Lipoprotein (LDL) Cholesterol

Borderline to High fasting LDL cholesterol: ≥100 milligrams/deciliter (mg/dL) and <160 mg/dL at baseline and ≥160 mg/dL any time post baseline; Normal to Borderline fasting LDL cholesterol: <100 mg/dL at baseline, ≥100 mg/dL and <160 mg/dL any time post baseline; Normal to High fasting LDL cholesterol: <100 mg/dL at baseline and ≥160 mg/dL any time post baseline.

Mean Change From Week 20 to Week 47 in Fasting High-Density Lipoprotein (HDL) Cholesterol

Percent of Participants With Treatment-Emergent Low Fasting High-Density Lipoprotein (HDL) Cholesterol

Normal to Low fasting HDL cholesterol is ≥40 milligrams/deciliter (mg/dL) at baseline and <40 mg/dL anytime post baseline.

Percent of Participants With Treatment-Emergent Hepatic Events

Participants with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 times the upper limit of normal (ULN) at baseline, with ALT or AST >=3 times the ULN post-baseline and total bilirubin >=2 times ULN at the same time are considered having treatment-emergent hepatic events.

Mean Change From Week 20 to Week 47 in Fasting Triglycerides

Percent of Participants With Treatment-Emergent High Fasting Triglycerides

Borderline to High fasting triglycerides: ≥150 milligrams/deciliter (mg/dL) and <200 mg/dL at baseline and ≥200 mg/dL any time post baseline; Normal to Borderline fasting triglycerides: <150 mg/dL at baseline, ≥150 mg/dL and <200 mg/dL any time post baseline; Normal to High fasting triglycerides: <150 mg/dL at baseline and ≥200 mg/dL any time post baseline.

Mean Change From Week 20 to Week 47 in Fasting Glucose

Percent of Participants With Treatment-Emergent High Fasting Glucose

Impaired to High fasting glucose: ≥100 milligrams/deciliter (mg/dL) and <126 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to High glucose: <100 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to Impaired fasting glucose is <100 mg/dL at baseline, ≥100 mg/dL and <126 mg/dL any time post baseline; Normal/Impaired to High fasting glucose: <126 mg/dL at baseline and ≥126 mg/dL any time post baseline.

Mean Change From Week 20 to Week 47 in Weight

Percent of Participants With Week 20-to-Week 47 Endpoint Increase in Weight of at Least 7%

Percent of Participants With Suicide-Related Thoughts and Behaviors

Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.

Mean Change in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram

Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes baseline (Week 20), treatment, country, visit, and treatment by visit interaction.

Percent of Participants With Treatment-Emergent Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram ≥500 Milliseconds (Msec)

Data presented are the percent of participants whose baseline corrected (for rate) cardiac QT interval <500 msec with post-baseline corrected (for rate) cardiac QT interval ≥500 msec.

Percent of Participants With a 60 Milliseconds (Msec) Increase in Fridericia-Corrected (for Rate) Cardiac QT Interval (QTcF) on Electrocardiogram

Full Information

NCT ID

NCT00958568

First Posted

August 12, 2009

Last Updated

February 17, 2014

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00958568

Brief Title

A Study in Relapse Prevention of Treatment-Resistant Depression

Official Title

A Study to Assess the Long-Term Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Fluoxetine Only in the Relapse Prevention of Stabilized Patients With Treatment-Resistant Depression

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant Depression stable, determine if OFC is safe when used to treat patients with Treatment Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression when treated for a long time (up to 47 weeks) and to assess the quality of life during treatment.

Detailed Description

This is a multicenter, randomized, double-blind, active comparator-controlled, parallel study of participants with Treatment Resistant Depression (TRD), comparing the efficacy and safety of olanzapine and fluoxetine Combination (OFC) versus fluoxetine in relapse prevention of stabilized participants with TRD. The study will consist of 4 phases: a screening phase; a 6- to 8-week open-label acute treatment phase; a 10- to 12-week open-label stabilization phase; and a 27- to 29-week double-blind relapse prevention treatment phase. Participants who demonstrate response to open-label OFC during the acute treatment phase will continue into the stabilization phase. Participants who remain stable while receiving open-label OFC during this phase will be randomized to receive either OFC or fluoxetine during the double-blind relapse prevention phase. Investigators and participants will be blinded to the precise duration of the stabilization period, the definition of remission, and the criteria for entry into the relapse prevention phase; this information is described in a supplement given to Ethical Review Boards (ERBs) and regulatory authorities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Resistant Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

892 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olanzapine and Fluoxetine combination (OFC)

Arm Type

Experimental

Arm Title

Fluoxetine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Olanzapine and Fluoxetine combination (OFC)

Other Intervention Name(s)

Symbyax, LY900000

Intervention Description

Open label acute phase: introductory dose for 4 days then 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks. Open label stabilization phase: 6/25, 12/25, 6/50, 12/50 or 18/50 mg, oral, daily for 16-20 weeks. Double blind relapse prevention phase: dose determined during stabilization phase at Week 17, oral, daily, for 27 weeks.

Intervention Type

Drug

Intervention Name(s)

Fluoxetine

Other Intervention Name(s)

Prozac, LY1101440

Intervention Description

25 or 50 mg/day fixed dosing for 27 weeks

Primary Outcome Measure Information:

Title

Time to Relapse by Any Criteria

Description

Time Frame

Randomization (Week 20) to Week 47

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Relapse by Any Criteria

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality

Time Frame

Randomization (Week 20) to Week 47

Title

Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Time to Relapse as Measured by Hospitalization for Depression or Suicidality

Description

Those who did not relapse were "censored" at their last observation.

Time Frame

Randomization (Week 20) to Week 47

Title

Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase

Description

Time Frame

Week 0 to Week 8

Title

Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase

Description

Time Frame

Week 8 to Week 20

Title

Percentage of Participants Achieving Remission at Any Point During Stabilization Treatment Phase

Description

Time Frame

Week 8 to Week 20

Title

Percentage of Participants Maintaining Remission

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Mixed-Effects Model Repeated Measures (MMRM) Analysis

Description

Time Frame

Randomization (Week 20), Week 47

Title

Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Last Observation Carried Forward (LOCF) Analysis

Description

Time Frame

Randomization (Week 20), up to Week 47

Title

Mean Change From Week 20 to Week 47 in Clinical Global Impressions - Severity (CGI-S) of Depression Using Mixed-Effects Model Repeated Measures (MMRM) Analysis

Description

Time Frame

Randomization (Week 20), Week 47

Title

Resource Utilization - Average Number of Hours Worked for Pay Per Week at Week 47

Time Frame

Week 47

Title

Resource Utilization (Number of Psychiatric Visits, Number of Emergency Room or Equivalent Facility Visits for Psychiatric Illness)

Description

Resource utilization is defined as the average number of psychiatric visits and number of emergency room or equivalent facility visits for psychiatric illness.

Time Frame

Randomization (Week 20) to Week 47

Title

Change From Week 20 to Week 47 Endpoint in the Sheehan Disability Scale (SDS)

Description

Time Frame

Randomization (Week 20), up to Week 47

Title

Percent of Participants With Treatment-Emergent Akathisia

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Percent of Participants With Treatment-Emergent Parkinsonism

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Percent of Participants With Treatment-Emergent Dyskinesia

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Mean Change From Week 20 to Week 47 in Fasting Total Cholesterol

Description

Time Frame

Randomization (Week 20), Week 47

Title

Percent of Participants With Treatment-Emergent High Fasting Total Cholesterol

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Mean Change From Week 20 to Week 47 in Fasting Low-Density Lipoprotein (LDL) Cholesterol

Description

Time Frame

Randomization (Week 20), Week 47

Title

Percent of Participants With Treatment-Emergent High Fasting Low-Density Lipoprotein (LDL) Cholesterol

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Mean Change From Week 20 to Week 47 in Fasting High-Density Lipoprotein (HDL) Cholesterol

Description

Time Frame

Randomization (Week 20), Week 47

Title

Percent of Participants With Treatment-Emergent Low Fasting High-Density Lipoprotein (HDL) Cholesterol

Description

Normal to Low fasting HDL cholesterol is ≥40 milligrams/deciliter (mg/dL) at baseline and <40 mg/dL anytime post baseline.

Time Frame

Randomization (Week 20) to Week 47

Title

Percent of Participants With Treatment-Emergent Hepatic Events

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Mean Change From Week 20 to Week 47 in Fasting Triglycerides

Description

Time Frame

Randomization (Week 20), Week 47

Title

Percent of Participants With Treatment-Emergent High Fasting Triglycerides

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Mean Change From Week 20 to Week 47 in Fasting Glucose

Description

Time Frame

Randomization (Week 20), Week 47

Title

Percent of Participants With Treatment-Emergent High Fasting Glucose

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Mean Change From Week 20 to Week 47 in Weight

Description

Time Frame

Randomization (Week 20), Week 47

Title

Percent of Participants With Week 20-to-Week 47 Endpoint Increase in Weight of at Least 7%

Time Frame

Week 20 to Week 47

Title

Percent of Participants With Suicide-Related Thoughts and Behaviors

Description

Time Frame

Randomization (Week 20) to Week 47

Title

Mean Change in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram

Description

Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes baseline (Week 20), treatment, country, visit, and treatment by visit interaction.

Time Frame

Randomization (Week 20), Week 47

Title

Percent of Participants With Treatment-Emergent Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram ≥500 Milliseconds (Msec)

Description

Data presented are the percent of participants whose baseline corrected (for rate) cardiac QT interval <500 msec with post-baseline corrected (for rate) cardiac QT interval ≥500 msec.

Time Frame

Randomization (Week 20) to Week 47

Title

Percent of Participants With a 60 Milliseconds (Msec) Increase in Fridericia-Corrected (for Rate) Cardiac QT Interval (QTcF) on Electrocardiogram

Time Frame

Randomization (Week 20) to Week 47

Other Pre-specified Outcome Measures:

Title

Kaplan-Meier Estimate of Percentage of Subjects Not Relapsing at Week 27 (Day 189)

Description

Relapse is defined as meeting any of the following criteria (Relapse-any reason): 50% increase in MADRS score from randomization with concomitant CGI-S of Depression score increase to a score of 4 or more (MADRS score/CGI-S Depression Score); Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.

Time Frame

Randomization (Week 20) to Week 27

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have single or recurrent unipolar Major Depressive Disorder (MDD), without psychotic features by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) clinical assessment, confirmed by the structured clinician Interview for DSM-IV Axis 1 disorders (SCID-I). If female and of childbearing potential, test negative for pregnancy and agree to abstain from sexual activity or use a medically accepted means of contraception during the study. Use of any oral or injectable contraception must be initiated prior to receiving treatment. Have 17-item Hamilton Depression (HAM-D) score greater than or equal to 18 at screening and the day treatment is due to be received for the first time. Have treatment-resistant depression, as defined by having demonstrated failure to achieve satisfactory antidepressant response to adequate separate treatment courses of at least 2 different antidepressants within the current episode of MDD. Exclusion Criteria: Have a diagnosis of Parkinson's disease or related disorders. Have a current or lifetime diagnosis of any of the following according to DSM-IV criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Bipolar Disorder I or II, Delirium of any type, Dementia of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition. Have current diagnosis of post-partum depression, MDD with atypical features, or MDD with a seasonal pattern as defined in the DSM-IV. Have paranoid, schizoid, schizotypal, antisocial, and borderline personality disorders (Axis II) as a comorbid or primary diagnosis, based on DSM-IV criteria. Have had psychotic symptoms within 1 month prior to Screening or demonstrate psychotic features at screening and on the day treatment is due to be assigned for the first time as determined by the investigator. Have DSM-IV substance dependence/abuse or not willing to avoid use of the substance (not including dependence on nicotine or caffeine), as defined by the SCID-I, within the past 30 days. Are actively suicidal in the judgment of the investigator. Have had one or more seizures without a clear and resolved etiology. Have leukopenia or history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the participant's lifetime. Have alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) values greater than or equal to 2 times the ULN or total bilirubin values greater than or equal to 1.5 times the ULN at any time during screening. Have acute, serious, or unstable medical conditions. Have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 6 months. Have elevated prolactin levels at screening. Have Bazett's corrected QT interval (QTc) greater than 450 milliseconds (male) or greater than 470 milliseconds (female) at screening and when treatment is due to be received for the first time. Have received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) treatment within the current episode; have a history of failure to adequate treatment courses of ECT or VNS; or will require ECT or VNS at any time during study participation. If receiving psychotherapy, light therapy, or both, are anticipated to require changes in frequency/intensity of treatment regimen or to cease treatment regimen over the duration of the study. Participants who are not receiving any of these therapies upon study entry may not begin any of these therapies during screening, or during any treatment phases of the study. Have received previous treatment with clozapine. Have used a monoamine oxidase inhibitor (MAOI) within 14 days prior to screening or are expected to need MAOI treatment at any time during this study through 5 weeks after the participant discontinues from the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Pasadena

State/Province

California

ZIP/Postal Code

91106

Country

United States

Facility Name

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

City

Wildomar

State/Province

California

ZIP/Postal Code

92595

Country

United States

Facility Name

City

Cromwell

State/Province

Connecticut

ZIP/Postal Code

06416

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

City

Oak Brook

State/Province

Illinois

ZIP/Postal Code

60523

Country

United States

Facility Name

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

City

Florence

State/Province

Kentucky

ZIP/Postal Code

41042

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21285

Country

United States

Facility Name

City

Glen Burnie

State/Province

Maryland

ZIP/Postal Code

21061

Country

United States

Facility Name

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

Facility Name

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

City

Bridgeton

State/Province

Missouri

ZIP/Postal Code

63044

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

City

St. Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

Facility Name

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03060

Country

United States

Facility Name

City

Cherry Hill

State/Province

New Jersey

ZIP/Postal Code

08002

Country

United States

Facility Name

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

City

Cedarhurst

State/Province

New York

ZIP/Postal Code

11516

Country

United States

Facility Name

City

Mount Kisco

State/Province

New York

ZIP/Postal Code

10549

Country

United States

Facility Name

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

City

Media

State/Province

Pennsylvania

ZIP/Postal Code

19063

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19139

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

City

Woodstock

State/Province

Vermont

ZIP/Postal Code

05091

Country

United States

Facility Name

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98004

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

City

Brown Deer

State/Province

Wisconsin

ZIP/Postal Code

53223

Country

United States

Facility Name

City

Middleton

State/Province

Wisconsin

ZIP/Postal Code

53562

Country

United States

Facility Name

City

West Allis

State/Province

Wisconsin

ZIP/Postal Code

53227

Country

United States

Facility Name

City

Banfield

ZIP/Postal Code

B1828CKR

Country

Argentina

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1122AAN

Country

Argentina

Facility Name

City

La Plata

ZIP/Postal Code

1900

Country

Argentina

Facility Name

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

City

Ahmedabad

ZIP/Postal Code

380013

Country

India

Facility Name

City

Bangalore

ZIP/Postal Code

560010

Country

India

Facility Name

City

Chennai

ZIP/Postal Code

600003

Country

India

Facility Name

City

Hyderabaad

ZIP/Postal Code

500034

Country

India

Facility Name

City

Ludhiana

ZIP/Postal Code

141001

Country

India

Facility Name

City

Mysore

ZIP/Postal Code

570004

Country

India

Facility Name

City

Raipur

ZIP/Postal Code

492001

Country

India

Facility Name

City

Col. Florida

ZIP/Postal Code

01030

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

14330

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64640

Country

Mexico

Facility Name

City

Ponce

ZIP/Postal Code

00731-7779

Country

Puerto Rico

Facility Name

City

Khotkovo

ZIP/Postal Code

127025

Country

Russian Federation

Facility Name

City

Nizhniy Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

192019

Country

Russian Federation

Facility Name

City

Village Nikolskoe

ZIP/Postal Code

188357

Country

Russian Federation

Facility Name

City

Bellville

ZIP/Postal Code

7530

Country

South Africa

Facility Name

City

Centurion

ZIP/Postal Code

0046

Country

South Africa

Facility Name

City

George

ZIP/Postal Code

6530

Country

South Africa

Facility Name

City

Kempton Park

ZIP/Postal Code

1619

Country

South Africa

Facility Name

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

City

Elazig

ZIP/Postal Code

23800

Country

Turkey

Facility Name

City

Gaziantep

Country

Turkey

Facility Name

City

Istanbul

ZIP/Postal Code

34303

Country

Turkey

Facility Name

City

İstanbul

ZIP/Postal Code

34736

Country

Turkey

Facility Name

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Facility Name

City

Sisli

ZIP/Postal Code

80220

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

A Study in Relapse Prevention of Treatment-Resistant Depression

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