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

Condition(s) targeted: Bipolar Disorder

Intervention: Olanzapine (Drug); Fluoxetine (Drug); Lamotrigine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: Olanzapine/Fluoxetine Combination Versus Lamotrigine in the Treatment of Bipolar I Depression

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine in the treatment of patients with bipolar I depression during the first 7 weeks of therapy.

Secondary outcome:

Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine on depressive symptoms

Assess the onset of action of olanzapine/fluoxetine combination compared with lamotrigine as measured by time to achieve an initial response

Assess the study-defined response and remission rates including time to achieve a full response and time to achieve remission as well as time to sustained response and sustained remission

Assess the time to and rate of relapse to depressive episode following remission for olanzapine/fluoxetine combination compared with lamotrigine

Assess the time to and rate of relapse to mania with olanzapine/fluoxetine combination compared with lamotrigine

Assess efficacy of treatment in improving symptomatology

Evaluate the level of health resource utilization and resource utilization costs associated with olanzapine/fluoxetine combination compared with lamotrigine during the study treatment period

Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine for suicide ideation

Assess the total time of hospitalization of patients on olanzapine/fluoxetine combination compared with lamotrigine during the study treatment period

Assess the safety and tolerability of olanzapine/fluoxetine combination compared with lamotrigine during 6 months of therapy

The sensitivity and positive predictive value of the MDQ will be determined in this study, using the SCID as a standard

To explore possible correlation between changes in eating behavior and changes in body weight

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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)

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

Lilly Clinical Trial Registry

Starting date: November 2003
Ending date: January 2005
Last updated: June 11, 2007