The Effect of a Weight Management Program to Prevent Weight Gain and Metabolic Abnormalities During Treatment With the Atypical Neuroleptic Olanzapine: A Randomised Study

Heinrich-Heine University, Duesseldorf1 site in 1 country100 target enrollmentJune 2003

ConditionsSchizophrenia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Heinrich-Heine University, Duesseldorf
Enrollment: 100
Locations: 1
Primary Endpoint: difference in mean weight gain
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a prospective, randomized, open-label study.

Detailed Description

The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

July 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

Inclusion Criteria

•Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
•Ages between 18 and 65
•Informed consent
•Weight gain of at least 1.5 kg in the first 4 weeks
•A sufficient understanding to participate adequately in the weight management program
•Patients must agree to cooperate with all tests and examinations required by the protocol.
•Each patient must understand the nature of the study and must sign an informed consent document.