Back to resultsOlanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Fluoxetine
Lamotrigine
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
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)
Sites / 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.
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00485771
Brief Title
Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression
Official Title
Olanzapine/Fluoxetine Combination Versus Lamotrigine in the Treatment of Bipolar I Depression
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine on depressive symptoms
Title
Assess the onset of action of olanzapine/fluoxetine combination compared with lamotrigine as measured by time to achieve an initial response
Title
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
Title
Assess the time to and rate of relapse to depressive episode following remission for olanzapine/fluoxetine combination compared with lamotrigine
Title
Assess the time to and rate of relapse to mania with olanzapine/fluoxetine combination compared with lamotrigine
Title
Assess efficacy of treatment in improving symptomatology
Title
Evaluate the level of health resource utilization and resource utilization costs associated with olanzapine/fluoxetine combination compared with lamotrigine during the study treatment period
Title
Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine for suicide ideation
Title
Assess the total time of hospitalization of patients on olanzapine/fluoxetine combination compared with lamotrigine during the study treatment period
Title
Assess the safety and tolerability of olanzapine/fluoxetine combination compared with lamotrigine during 6 months of therapy
Title
The sensitivity and positive predictive value of the MDQ will be determined in this study, using the SCID as a standard
Title
To explore possible correlation between changes in eating behavior and changes in body weight
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Lafayette
State/Province
Indiana
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21095016
Citation
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.
Results Reference
derived
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Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression
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