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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485771
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Olanzapine
Drug: Fluoxetine
Drug: Lamotrigine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Olanzapine/Fluoxetine Combination Versus Lamotrigine in the Treatment of Bipolar I Depression

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Enrollment: 403
Study Start Date: November 2003
Study Completion Date: January 2005
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485771

Locations
United States, Indiana
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00485771     History of Changes
Other Study ID Numbers: 7980, H6P-US-HDAQ
Study First Received: June 11, 2007
Last Updated: June 11, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Fluoxetine
Olanzapine
Lamotrigine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents
Anticonvulsants
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Antiemetics

ClinicalTrials.gov processed this record on April 16, 2014