Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 24, 2007

Start Date ^ICMJE

May 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

-MADRS is a rating scale for severity of depressive mood symptoms.

Change History

Complete list of historical versions of study NCT00191399 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

-GGI-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.
-SF-12 Questionaire. It was developed from the SF-36 Health Survey for use in monitoring outcomes for general and specific populations.

Descriptive Information

Brief Title ^ICMJE

Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response

Official Title ^ICMJE

Bipolar Depression Assessment Study on Tx Response

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Depression, Bipolar

Intervention ^ICMJE

Drug: Olanzapine
Drug: Fluoxetine

Study Arms / Comparison Groups

Publications *

Tamayo JM, Sutton VK, Mattei MA, Diaz B, Jamal HH, Vieta E, Zarate CA Jr, Fumero I, Tohen M. Effectiveness and safety of the combination of fluoxetine and olanzapine in outpatients with bipolar depression: an open-label, randomized, flexible-dose study in Puerto Rico. J Clin Psychopharmacol. 2009 Aug;29(4):358-61.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

March 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00191399

Responsible Party

Study ID Numbers ^ICMJE

9370, F1D-SU-HGMA

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

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)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP