The Assessment of a Weight Management Program for Treatment-Emergent Weight Gain in Patients With Schizophrenia, Schizophreniform Disorder, and Schizoaffective Disorder During Olanzapine Therapy

Eli Lilly and Company1 site in 1 country48 target enrollmentDecember 2002

ConditionsSchizophrenic Disorders

DrugsOlanzapine Hydrochloride

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Schizophrenic Disorders
Sponsor: Eli Lilly and Company
Enrollment: 48
Locations: 1
Primary Endpoint: Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

September 2003

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.