Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression

NCT ID: NCT00485771

Last Updated: 2007-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2005-01-31

Brief Summary

The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar depression.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Olanzapine

Intervention Type: DRUG

Fluoxetine

Intervention Type: DRUG

Lamotrigine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patients, 18 to 60 years of ages, inpatients or outpatients. Inpatients are qualified only if they are hospitalized for current episode of bipolar depression and should be able to leave hospital when clinical criteria are no longer met for acute inpatient hospitalization
• Patients must fulfill the criteria for bipolar I depression (bipolar I disorder, current episode major depressive) as defined in DSM-IV-TR based on clinical examination and psychiatric assessment
• Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode as defined in DSM-IV-TR, of sufficient severity to require treatment with a mood stabilizer or an antipsychotic as reported by the patient or the caregiver
• Each patient must have a level of understanding sufficient to perform all tests and examinations required by the protocol
• Female patients must test negative for pregnancy and must be using a medically accepted means of contraception

Exclusion Criteria

• Current diagnosis of any of the following according to DSM-IV-TR criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Delirium of any type, Dementia of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition, unless there is substantive reason to believe patient was previously misdiagnosed.
• Treatment with clozapine within 3 months (90 days) prior to visit 1
• Treatment with electroconvulsive therapy (ECT) within 3 months (90 days) prior to visit 2
• Patients with seizure disorders are excluded (except patients with a previous history of seizures due to alcohol withdrawal, which have resolved).
• Participation in a clinical trial of another drug including olanzapine, fluoxetine or lamotrigine within 30 days prior to study entry (visit 1)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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.

Lafayette, Indiana, United States

Countries

United States

References

Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.

Reference Type: DERIVED

PMID: 21095016 (View on PubMed)

Other Identifiers

H6P-US-HDAQ

Identifier Type: -

Identifier Source: secondary_id

7980

Identifier Type: -

Identifier Source: org_study_id