Back to results

Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

Primary Purpose

Depressive Disorder, Major

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Duloxetine

placebo

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

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

Inclusion Criteria: Patient must be at least 18 years old. Patient must be diagnosed with depression and have had previous episodes of depression. Patient must sign informed consent. Exclusion Criteria: Female and pregnant or breastfeeding. History of bipolar disorder, schizophrenia, or other psychotic disorders. Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization. Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study. Have taken an antidepressant called fluoxetine within 30 days of the start of 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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 9 AM - 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

Placebo Comparator

Arm Label

Arm Description

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With Depressive Recurrence After Time (t) in Days

Recurrence: Clinical Global Impression-Severity (CGI-S) score >=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.

Secondary Outcome Measures

Recurrence Count

Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.

Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days

Worsening occurs if patient had a >=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score >=3 at any time during the double-blind maintenance therapy phase.

Loss of Response at Any Time

Loss of response was defined as a HAMD-17 total score >9 and a CGI-Severity score >2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not.

Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases

The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).

Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase

The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).

Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases

Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase

Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.

Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases

Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4).

Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).

Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase

Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases

The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.

Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase

Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases

The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.

Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase

Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase

Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.

Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase

Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases

Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.

Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)

A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)

Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases

Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase

Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases

Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase

Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases

Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase

Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase

Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase

Full Information

NCT ID

NCT00105989

First Posted

March 18, 2005

Last Updated

July 21, 2009

Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00105989

Brief Title

Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

Official Title

Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

6. Conditions and Keywords

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

Depressive Disorder, Major

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

514 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks

Arm Title

Arm Type

Placebo Comparator

Arm Description

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

LY248686, Cymbalta

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Percentage of Participants With Depressive Recurrence After Time (t) in Days

Description

Time Frame

Every Visit from Week 34 up to Week 86 (Maintenance Phase)

Secondary Outcome Measure Information:

Title

Recurrence Count

Description

Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.

Time Frame

Every Visit from Week 35 up to Week 86 (Maintenance Phase)

Title

Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days

Description

Time Frame

Every Visit from Week 34 up to Week 86 (Maintenance Phase)

Title

Loss of Response at Any Time

Description

Time Frame

Every Visit from Week 35 up to Week 86 (Maintenance Phase)

Title

Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases

Description

Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase

Description

Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases

Description

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Time Frame

Week 10 (Acute) and Week 34 (Continuation)

Title

Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase

Description

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Time Frame

Week 86 (Maintenance Phase)

Title

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases

Description

Time Frame

Week 0 through Week10 (Acute) through Week 34 (Continuation)

Title

Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase

Description

Time Frame

Week 34 through Week 86 (Maintenance Phase)

Title

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)

Description

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)

Description

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases

Time Frame

Week 0 and Week 10 (Acute) and Week 34 (Continuation)

Title

Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase

Time Frame

Week 0 and Week 10

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase

Time Frame

Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase

Time Frame

Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

Title

Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase

Time Frame

Every Visit from Week 0 up to Week 10 (Acute)

Title

Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase

Time Frame

Every Visit from Week 10 up to Week 34 (Continuation)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Newport Beach

State/Province

California

Country

United States

Facility Name

City

Sherman Oaks

State/Province

California

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

City

Gaithersburg

State/Province

Maryland

Country

United States

Facility Name

City

Brooklyn

State/Province

New York

Country

United States

Facility Name

City

Angouleme

Country

France

Facility Name

City

Douai

Country

France

Facility Name

City

Fains

Country

France

Facility Name

City

La Rochelle

Country

France

Facility Name

City

Lille

Country

France

Facility Name

City

Nimes

Country

France

Facility Name

City

Roubaix

Country

France

Facility Name

City

Strasbourg

Country

France

Facility Name

City

Berlin

Country

Germany

Facility Name

City

Ellwangen

Country

Germany

Facility Name

City

Hamburg

Country

Germany

Facility Name

City

Hildesheim

Country

Germany

Facility Name

City

Leipzig

Country

Germany

Facility Name

City

Munchen

Country

Germany

Facility Name

City

Wurzburg

Country

Germany

Facility Name

City

Catania

Country

Italy

Facility Name

City

Ferrara

Country

Italy

Facility Name

City

Firenze

Country

Italy

Facility Name

City

Parma

Country

Italy

Facility Name

City

Roma

Country

Italy

Facility Name

City

Torino

Country

Italy

Facility Name

City

Moscow

Country

Russian Federation

Facility Name

City

St. Petersburg

Country

Russian Federation

Facility Name

City

Village Nikolskoe

Country

Russian Federation

Facility Name

City

Halmstad

Country

Sweden

Facility Name

City

Lund

Country

Sweden

Facility Name

City

Malmo

Country

Sweden

Facility Name

City

Stockholm

Country

Sweden

Facility Name

City

Sundsvall

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

19552867

Citation

Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16. doi: 10.4088/jcp.08m04756. Erratum In: J Clin Psychiatry. 2009 Dec;70(12):1729.

Results Reference

derived

Learn more about this trial

Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

We'll reach out to this number within 24 hrs