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

Lilly

Status and phase

Completed

Phase 4

Conditions

Schizophrenic Disorders

Treatments

Procedure: Weight Management Program

Drug: Olanzapine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00485823

6696

F1D-KL-S031

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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