Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191399
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 12, 2005
January 24, 2007
May 2004
Not Provided
MADRS is a rating scale for severity of depressive mood symptoms.
-MADRS is a rating scale for severity of depressive mood symptoms.
Complete list of historical versions of study NCT00191399 on ClinicalTrials.gov Archive Site
  • 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.
  • -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.
Not Provided
Not Provided
 
Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response
Bipolar Depression Assessment Study on Tx Response

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression, Bipolar
  • Drug: Olanzapine
  • Drug: Fluoxetine
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
March 2006
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00191399
9370, F1D-SU-HGMA
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
January 2007

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