The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder

NCT ID: NCT00044187

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2003-09-30

Brief Summary

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Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight gain that may be associated with taking olanzapine.

The purposes of this study are to determine the safety of olanzapine when given in combination with the Anti-obesity Agent and any side effects that might be associated with it and whether weight-gain agent can help treat weight gain that may be associated with taking olanzapine.

Detailed Description

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Conditions

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Schizophrenia Psychotic Disorders Bipolar Disorder

Keywords

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schizoaffective disorder schizophreniform disorder bipolar I disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sibutramine

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* You have a history of an illness that would cause weight loss or gain in the near future.
* You have taken remoxipride within the past 6 months.
* You are allergic to olanzapine or Anti-obesity Agent.
* You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke.
* You have a serious medical illness, such as heart, liver, or kidney disease.
* You are pregnant or breast feeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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El Centro, California, United States

Site Status

Jacksonville, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Boise, Idaho, United States

Site Status

Chicago, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Lafayette, Indiana, United States

Site Status

Prairie Village, Kansas, United States

Site Status

Milford, Massachusetts, United States

Site Status

Clementon, New Jersey, United States

Site Status

Beachwood, Ohio, United States

Site Status

Johnson City, Tennessee, United States

Site Status

Memphis, Tennessee, United States

Site Status

Houston, Texas, United States

Site Status

Richmond, Virginia, United States

Site Status

Bellevue, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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F1D-MC-HGJJ

Identifier Type: -

Identifier Source: secondary_id

5102

Identifier Type: -

Identifier Source: org_study_id