Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response

NCT00191399 | Completed Phase 4

• 2 other identifiers: 9370F1D-SU-HGMA
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 10

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).

Conditions

Depression, Bipolar

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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.

Interventions

Olanzapine DRUG

Fluoxetine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (10)

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, United States

Location

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

Bayamón, 00956, Puerto Rico

Location

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, 725, Puerto Rico

Location

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

Location

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, 00936, Puerto Rico

Location

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

Manatí, 00674, Puerto Rico

Location

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

Mayagüez, 00680, Puerto Rico

Location

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

Location

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

Location

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

Location

Related Publications (1)

• 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. doi: 10.1097/JCP.0b013e3181ad223f.

  PMID: 19593175 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Olanzapine; Fluoxetine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: May 1, 2004
• Study Completion: March 1, 2006
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

PR (9); US (1)