Olanzapine Treatment of Patients With Bipolar I Disorder

Condition(s) targeted: Depression, Bipolar

Intervention: Olanzapine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Assess whether olanzapine is superior to placebo in patients with bipolar depression based on improvements in overall symptomatology, measured by the mean change in the Montgomery-Åsberg Depression Rating Scale total score.

Secondary outcome:

Assess olanzapine compared with placebo in terms of rate of response.

Assess olanzapine compared with placebo in terms of remission of depression.

Assess olanzapine compared with placebo in terms of improvement in clinical symptomatology, based on reductions from baseline in scores of the Clinical Global Impressions-Bipolar Version Severity of Illness scale.

Assess olanzapine compared with placebo in terms of the rate of recovery, defined as a reduction in the Montgomery-Åsberg Depression Rating Scale total score for at least 4 weeks of treatment (post-baseline) and completion of the double-blind treatment.

Assess olanzapine compared with placebo in terms of the improvement in clinical symptomology, based on the reductions of scores from baseline on the Young Mania Rating Scale.

Assess olanzapine compared with placebo in terms of the improvement in clinical symptomatology, based on reductions from baseline in the Hamilton Depression Rating Scale-17 items scores.

Assess olanzapine compared with placebo in terms the presence of specific syndromic criteria, assessed by the Mini International Neuropsychiatric Interview major depressive episode (or major depressive episode with melancholic features) module.

Assess olanzapine compared with placebo in terms of the presence of specific syndromic criteria, assessed by the Mini International Neuropsychiatric Interview manic episode module.

Assess olanzapine compared with placebo in terms of the presence or absence of specific syndromic criteria, assessed by the Mini International Neuropsychiatric Interview psychotic disorders module.

Assess olanzapine compared with placebo in Mini International Neuropsychiatric Interview alcohol dependence/abuse module.

Assess olanzapine compared with placebo in terms of the presence or absence of specific syndromic criteria, assessed by the Mini International Neuropsychiatric Interview substance dependence/abuse module.

Assess olanzapine compared with placebo in terms of the emergence of mania, defined as an increase in the Young Mania Rating Scale total score.

Assess olanzapine compared with placebo in terms of the incidence and severity of extrapyramidal symptoms as measured by the Drug-Induced Extrapyramidal Symptoms Scale.

Assess olanzapine compared with placebo in terms of safety as measured by treatment-emergent adverse events.

Assess olanzapine compared with placebo in terms of safety as measured by changes in vital signs.

Assess olanzapine compared with placebo in terms of safety as measured by changes in laboratory analytes.

Assess olanzapine compared with placebo in terms of safety as measured by changes in Electrocardiograms.

Assess olanzapine compared with placebo in terms of suicidality or serious suicide risk, as determined by an investigator's clinical judgement or increase on the suicidality module of the Mini International Neuropsychiatric Interview.

Assess open-label olanzapine in terms of the rate of response with response defined as a reduction (from baseline to endpoint) of 50% or more in the Montgomery-Åsberg Depression Rating Scale total score.

Assess open-label olanzapine in terms of the rate of remission of depression as defined as a score of less than or equal to 12 in the Montgomery-Åsberg Depression Rating Scale total score.

Assess open-label olanzapine in terms of the rate of recovery as defined as a value of less than or equal to 12 in the Montgomery-Åsberg Depression Rating Scale total score for at least 4 weeks of treatment (post-baseline).

Assess open-label olanzapine in terms of the rate of improvement in clinical symptomatology, based on reductions of Young Mania Rating Scale scale scores from baseline.

Assess open-label olanzapine in terms of the rate of emergence of mania, defined as a Young Mania Rating Scale total score greater than or equal to 15.

Assess open-label olanzapine in terms of the rate of the incidence and severity of extra-pyramidal symptoms as measured by the Drug-Induced Extrapyramidal Symptoms Scale.

Assess open-label olanzapine in terms of safety, as measured by Treatment Emergent Adverse Events.

Assess open-label olanzapine in terms of safety, as measured by change in vital signs.

Assess open-label olanzapine in terms of safety as measured by electrocardiograms.

Assess open-label olanzapine in terms of suicidality rate or serious suicide risk, determined by an investigator's clinical judgement or by a score greater than or equal to 17 on the Mini International Neuropsychiatric Interview suicidality module.

Detailed description:

1. Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day

2. Duration:

1. Screening phase is 2-28 days.

2. Double-blind treatment phase is 6 weeks

3. Open-label extension phase is 18 weeks

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

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, at study entry

- Patients must have a current HAMD-17 score greater than or equal to 18 at V1 and V2

- Patients must have a current YMRS total score less than or equal to 8 at V2.

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 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 was prescribed at an appropriate dose and duration

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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., Beijing 100088, China; Recruiting
Eli Lilly

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., Changsha 410008, China; Recruiting
Eli Lilly

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., Chengdu 610041, China; Recruiting
Eli Lilly

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., Guang Zhou 510370, China; Recruiting
Eli Lilly

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., Hangzhou 310003, China; Recruiting
Eli Lilly

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., Harbin 150001, China; Recruiting
Eli Lilly

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., Kunming 650032, China; Recruiting
Eli Lilly

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., Nanjing 210029, China; Recruiting
Eli Lilly

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., Shanghai 200030, China; Recruiting
Eli Lilly

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., Wu Han 430060, China; Recruiting
Eli Lilly

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., Xi'An 710032, China; Recruiting
Eli Lilly

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., Hiroshima 731-0501, Japan; Recruiting
Eli Lilly

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., Chiba 270-1694, Japan; Recruiting
Eli Lilly

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., Saitama 332-0012, Japan; Recruiting
Eli Lilly

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., Shiga 525-0037, Japan; Recruiting
Eli Lilly

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., Kyoto 616-8421, Japan; Recruiting
Eli Lilly

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., Osaka 543-0056, Japan; Recruiting
Eli Lilly

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., Iwate 023-0801, Japan; Recruiting
Eli Lilly

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., Tokyo 170-0002, Japan; Recruiting
Eli Lilly

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., Aichi 470-1168, Japan; Recruiting
Eli Lilly

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., Yamaguchi 755-8505, Japan; Recruiting
Eli Lilly

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., Kanagawa 231-0027, Japan; Recruiting
Eli Lilly

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., Seonnam City 463-707, Korea, Republic of; Recruiting
Eli Lilly

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., Seoul 138-736, Korea, Republic of; Recruiting
Eli Lilly

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., Kao Hsiung 802, Taiwan; Recruiting
Eli Lilly

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., Keelung 204, Taiwan; Recruiting
Eli Lilly

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., Neihu Taipei 114, Taiwan; Recruiting
Eli Lilly

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., Taipei 116, Taiwan; Recruiting
Eli Lilly

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., Tao-Yuan 333, Taiwan; Recruiting
Eli Lilly

Lilly Clinical Trial Registry

Starting date: August 2007
Ending date: July 2010
Last updated: November 17, 2008