Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response

Depression, Bipolar Clinical Trial

Official title:

Bipolar Depression Assessment Study on Tx Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191399
• Other study ID #: 9370
• Secondary ID: F1D-SU-HGMA
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: May 2004
• Est. completion date: March 2006

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

Intervention

Drug:
• Olanzapine

• Fluoxetine

Locations

Country	Name	City	State
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician	Bayamon
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician	Caguas
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician	Canovanas
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	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	Manati
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician	Mayaguez
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician	Rio Piedras
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician	San Juan
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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician	Santurce
United States	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.	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS is a rating scale for severity of depressive mood symptoms.
Secondary	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
Secondary	CGI-BP Severity - Mania is used by the clinician to record the severity of mania illness at the time of assessment
Secondary	Short Form-12 (SF-12) Questionnaire was developed from the SF-36 Health Survey for use in monitoring outcomes for general and specific populations.