Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response

Phase 4

Completed

• Conditions: Depression, Bipolar

• Registration Number: NCT00191399
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-03
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-24
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Meet criteria for bipolar depression, in the opinion of the investigator, according to the Diagnostic and Statistical Manual of Mental Disorders [Text Revision] (DSM-IV-TR) disease diagnostic criteria.
• Patients must have experienced, in the opinion of the investigator, at least one previous hypomanic, manic or mixed episode as defined in DSM-IV-TR.
• Subjects must have an initial score at Visit 1 of at least 20 on the MADRS.

Exclusion Criteria

• Any patient currently meeting DSM-IV-TR criteria rapid-cycling course.
• A CGI-Severity - Mania score of at least 3.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MADRS is a rating scale for severity of depressive mood symptoms.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Bipolar Version (CGI-BP) Severity - Depression is used by the clinician to record the severity of depression illness at the time of assessment
CGI-BP Severity - Mania is used by the clinician to record the severity of mania illness at the time of assessment
Short Form-12 (SF-12) Questionnaire was developed from the SF-36 Health Survey for use in monitoring outcomes for general and specific populations.

Trial Locations

Locations (2)

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

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.; 🇵🇷 Hato Rey, Puerto Rico