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Olanzapine Treatment of Patients With Bipolar I Disorder

Primary Purpose

Depression, Bipolar

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Olanzapine

Placebo

About this trial

This is an interventional treatment trial for Depression, Bipolar

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent
All female patients must test negative for pregnancy and females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug
Patients must fulfill the criteria for a major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) as well as criteria for bipolar I disorder, depressed, as defined in the DSM-IV-TR, based on clinical assessment and confirmed by the structured diagnostic interview, the Mini International Neuropsychiatric Interview (MINI), at study entry
Patients must have a current 17-item Hamilton Depression Rating Scale (HAMD-17) score greater than or equal to 18 at Visit 1 and Visit 2
Patients must have a current Young Mania Rating Scale (YMRS) total score less than or equal to 8 at Visit 2.

Exclusion Criteria:

Has received treatment within the past 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry
Has participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) before study entry
Was previously treated with olanzapine and had bipolar depression considered to be treatment-resistant to olanzapine or to olanzapine in combination with an available selective serotonin reuptake inhibitor (SSRI)
Is experiencing (at the time of study entry) a current episode of bipolar depression that is greater than 90 days in duration
Has been treatment-resistant to any therapy prescribed for bipolar depression when olanzapine alone or with an SSRI prescribed at an appropriate dose and duration

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Olanzapine

Placebo

Olanzapine (open-label treatment period)

Arm Description

During double-blind treatment, participants receive olanzapine at a dose of 5 milligram (mg) which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.

Matching placebo administered once daily, by mouth during double-blind treatment.

During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and Week 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.

Outcomes

Primary Outcome Measures

Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)

The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are 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).

Secondary Outcome Measures

Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase)

Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are 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 With Symptomatic Remission At Any Time (Acute Phase)

Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are 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).

Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase)

CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The score ranges from 1 (normal, not ill) to 7 (very seriously ill).

Percentage of Participants With Recovery (Acute Phase)

Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are 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).

Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase)

The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

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

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).

Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase)

In the MINI Major Depressive Episode module, participants are asked a series of Yes/No questions to determine whether or not they are experiencing a major depressive episode or a major depressive episode with melancholic features.

Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase)

In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes.

Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase)

In the MINI Psychotic Features Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing mood disorder with psychotic features or current psychotic disorders.

Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase)

In the MINI Alcohol Abuse and Dependence Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current alcohol dependence or abuse.

Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase)

In the MINI Substance Dependence and Abuse Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current non-alcohol substance use dependence or abuse.

Percentage of Participants With Emergence of Mania During the Study (Acute Phase)

Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase)

EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.

Change From Baseline to Endpoint in Blood Pressure (Acute Phase)

Change From Baseline to Endpoint in Weight (Acute Phase)

Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol)

Change From Baseline to Endpoint in Albumin (Acute Phase)

Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT)

Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase)

Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase)

Change From Baseline to Endpoint in Hematocrit (Acute Phase)

Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase)

Change From Baseline to Endpoint in Hemoglobin (Acute Phase)

Change From Baseline to Endpoint in Prolactin (Acute Phase)

Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase)

Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase)

Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).

Change From Baseline to Endpoint in Heart Rate (Acute Phase)

Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase)

The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors.

Number of Participants With Adverse Events (Acute Phase)

Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.

Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase)

Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase)

Percentage of Participants With Recovery (Open-Label Phase)

Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase)

Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase)

Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the Open-Label Extension. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase)

Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase)

Change From Baseline to Endpoint in Weight (Open-Label Phase)

Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase)

Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase)

Change From Baseline to Endpoint in Chloride (Open-Label Phase)

Change From Baseline to Endpoint in Creatinine (Open-Label Phase)

Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase)

Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase)

Change From Baseline to Endpoint in Platelet Count (Open-Label Phase)

Change From Baseline to Endpoint in Prolactin (Open-Label Phase)

Change From Baseline to Endpoint in Uric Acid (Open-Label Phase)

Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase)

Change From Baseline to Endpoint in ECG (Open-Label Phase)

Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).

Change From Baseline to Endpoint in Heart Rate (Open-Label Phase)

Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase)

Number of Participants With Adverse Events (Open-Label Phase)

Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.

Full Information

NCT ID

NCT00510146

First Posted

July 30, 2007

Last Updated

April 26, 2011

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00510146

Brief Title

Olanzapine Treatment of Patients With Bipolar I Disorder

Official Title

Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder, Depressed: A Randomized, Double-Blind Comparison With Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.

Detailed Description

Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day Duration: Screening phase is 2-28 days. Double-blind treatment phase is 6 weeks Open-label extension phase is 18 weeks

6. Conditions and Keywords

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

Depression, Bipolar

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

Olanzapine

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo administered once daily, by mouth during double-blind treatment.

Arm Title

Olanzapine (open-label treatment period)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Other Intervention Name(s)

LY170053, Zyprexa

Intervention Description

5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo tablets, oral, once daily at bedtime, 6 weeks

Primary Outcome Measure Information:

Title

Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)

Description

Time Frame

Baseline, Endpoint (Week 6)

Secondary Outcome Measure Information:

Title

Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase)

Description

Time Frame

Endpoint (Week 6)

Title

Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase)

Description

Time Frame

Baseline through Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase)

Description

Time Frame

Baseline, Endpoint (Week 6)

Title

Percentage of Participants With Recovery (Acute Phase)

Description

Time Frame

Baseline through Endpoint (Week 6 )

Title

Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase)

Description

Time Frame

Baseline, Endpoint (Week 6)

Title

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

Description

Time Frame

Baseline, Endpoint (Week 6)

Title

Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase)

Description

Time Frame

Endpoint (Week 6)

Title

Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase)

Description

In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes.

Time Frame

Endpoint (Week 6)

Title

Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase)

Description

Time Frame

Endpoint (Week 6)

Title

Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase)

Description

Time Frame

Endpoint (Week 6)

Title

Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase)

Description

Time Frame

Endpoint (Week 6)

Title

Percentage of Participants With Emergence of Mania During the Study (Acute Phase)

Description

Time Frame

Baseline through Endpoint (Week 6)

Title

Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase)

Description

Time Frame

Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Blood Pressure (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Weight (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Albumin (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Hematocrit (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Hemoglobin (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Prolactin (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase)

Description

Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in Heart Rate (Acute Phase)

Time Frame

Baseline, Endpoint (Week 6)

Title

Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase)

Description

Time Frame

Baseline, Endpoint (Week 6)

Title

Number of Participants With Adverse Events (Acute Phase)

Description

Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.

Time Frame

Baseline through Week 6 (Acute Phase)

Title

Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase)

Description

Time Frame

Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)

Title

Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase)

Description

Time Frame

Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)

Title

Percentage of Participants With Recovery (Open-Label Phase)

Description

Time Frame

Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase)

Description

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase)

Description

Time Frame

Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)

Title

Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase)

Description

Time Frame

Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Weight (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/ Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Chloride (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Creatinine (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Platelet Count (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Prolactin (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Uric Acid (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in ECG (Open-Label Phase)

Description

Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Change From Baseline to Endpoint in Heart Rate (Open-Label Phase)

Time Frame

Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)

Title

Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase)

Description

Time Frame

Endpoint (Week 24)

Title

Number of Participants With Adverse Events (Open-Label Phase)

Description

Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.

Time Frame

Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent All female patients must test negative for pregnancy and females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug Patients must fulfill the criteria for a major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) as well as criteria for bipolar I disorder, depressed, as defined in the DSM-IV-TR, based on clinical assessment and confirmed by the structured diagnostic interview, the Mini International Neuropsychiatric Interview (MINI), at study entry Patients must have a current 17-item Hamilton Depression Rating Scale (HAMD-17) score greater than or equal to 18 at Visit 1 and Visit 2 Patients must have a current Young Mania Rating Scale (YMRS) total score less than or equal to 8 at Visit 2. Exclusion Criteria: Has received treatment within the past 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry Has participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) before study entry Was previously treated with olanzapine and had bipolar depression considered to be treatment-resistant to olanzapine or to olanzapine in combination with an available selective serotonin reuptake inhibitor (SSRI) Is experiencing (at the time of study entry) a current episode of bipolar depression that is greater than 90 days in duration Has been treatment-resistant to any therapy prescribed for bipolar depression when olanzapine alone or with an SSRI prescribed at an appropriate dose and duration

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 - 5hrs, 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

Beijing

ZIP/Postal Code

100088

Country

China

Facility Name

City

Changsha

ZIP/Postal Code

410008

Country

China

Facility Name

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

City

Guang Zhou

ZIP/Postal Code

510370

Country

China

Facility Name

City

Hangzhou

ZIP/Postal Code

310003

Country

China

Facility Name

City

Harbin

ZIP/Postal Code

150001

Country

China

Facility Name

City

Kunming

ZIP/Postal Code

650032

Country

China

Facility Name

City

Nanjing

ZIP/Postal Code

210029

Country

China

Facility Name

City

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

City

Wu Han

ZIP/Postal Code

430060

Country

China

Facility Name

City

Xi'An

ZIP/Postal Code

710032

Country

China

Facility Name

City

Hiroshima

ZIP/Postal Code

731-0501

Country

Japan

Facility Name

City

Shiga

ZIP/Postal Code

525-0037

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

170-0002

Country

Japan

Facility Name

City

Seongnam-Si

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

24417745

Citation

Katagiri H, Tohen M, McDonnell DP, Fujikoshi S, Case M, Kanba S, Takahashi M, Gomez JC. Safety and efficacy of olanzapine in the long-term treatment of Japanese patients with bipolar I disorder, depression: an integrated analysis. Psychiatry Clin Neurosci. 2014 Jul;68(7):498-505. doi: 10.1111/pcn.12156. Epub 2014 Mar 4.

Results Reference

derived

PubMed Identifier

23672672

Citation

Katagiri H, Tohen M, McDonnell DP, Fujikoshi S, Case M, Kanba S, Takahashi M, Gomez JC. Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Japanese subpopulation analysis of a randomized, double-blind, placebo-controlled study. BMC Psychiatry. 2013 May 14;13:138. doi: 10.1186/1471-244X-13-138.

Results Reference

derived

PubMed Identifier

22918966

Citation

Tohen M, McDonnell DP, Case M, Kanba S, Ha K, Fang YR, Katagiri H, Gomez JC. Randomised, double-blind, placebo-controlled study of olanzapine in patients with bipolar I depression. Br J Psychiatry. 2012 Nov;201(5):376-82. doi: 10.1192/bjp.bp.112.108357. Epub 2012 Aug 23.

Results Reference

derived

Learn more about this trial

Olanzapine Treatment of Patients With Bipolar I Disorder

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