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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00485823

Enrollment

Registered

2007-06-13

Start date

2002-12-31

Completion date

2003-09-30

Last updated

2007-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenic Disorders

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.

Interventions

DRUGOlanzapine Hydrochloride

PROCEDUREWeight Management Program

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group	—

Secondary

Measure	Time frame
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.	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026