Assessment of a Weight Management Program for Weight Gain in Patients With Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenic Disorders

• Registration Number: NCT00485823
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to develop the weight management program, which is combined with healthy diet, proper physical exercise, and behavior modification, related to patient's quality of life. The patients groups are in routine practice with 5-20 mg olanzapine. The study results may be utilized for patients who have gained weight on olanzapine and also other antipsychotic drugs.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-12
• Study Completion: 2003-09
• Status Verified: 2007-06
• Study First Submitted: 2007-06-11
• Study First Submitted QC: 2007-06-11
• Last Update Submitted: 2007-06-11
• Study First Posted: 2007-06-13
• Last Update Posted: 2007-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Male and female patients between the ages of 18 and 65 years (inclusive)
• Subjects must meet the DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder
• Subjects must have been treated with olanzapine (5 to 20 mg/day) for at least 12 weeks prior to study entry and who experienced a weight gain of greater than or equal to 7% of body weight during olanzapine treatment

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Exclusion Criteria

• Treatment with an injectable depot neuroleptic 14 days before visit 1
• Subjects with an PANSS score greater than 70
• One or more seizures without a clear and unresolved etiology
• Known diagnosis of DSM-IV substance dependence (except nicotine and caffeine) within the past 2 months, which in the opinion of the investigator is affecting the diet and/or weight of the subject
• As a result of liver function test, ALT/AST ranges are shown twice the upper limit of the normal reference range

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline to endpoint in the Stunkard and Messick Eating Inventory
Measure safety parameters, including medical history, psychiatric and physical examinations, vital signs (blood pressure, pulse and weight), clinical laboratory tests and record of symptoms
Severity of psychiatric symptoms and extrapyramidal symptoms were monitored using the PANSS and the AIMS, respectively.

Trial Locations

Locations (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.; 🇰🇷 Seoul, Korea, Republic of