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

Study 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.

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

Conditions
-----------------
Schizophrenic Disorders

Intervention / Treatment
-----------------
* Drug: Olanzapine Hydrochloride
* Procedure: Weight Management Program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olanzapine Hydrochloride|nan|
|Procedure: Weight Management Program|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  |