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

Schizophrenic Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485823
• Other study ID #: 6696
• Secondary ID: F1D-KL-S031
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: December 2002
• Est. completion date: September 2003

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenic Disorders
• Weight Gain

Intervention

Drug:
• Olanzapine Hydrochloride

Procedure:
• Weight Management Program

Locations

Country	Name	City	State
Korea, Republic of	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group
Secondary	Mean change from baseline to endpoint in the Stunkard and Messick Eating Inventory
Secondary	Measure safety parameters, including medical history, psychiatric and physical examinations, vital signs (blood pressure, pulse and weight), clinical laboratory tests and record of symptoms
Secondary	Severity of psychiatric symptoms and extrapyramidal symptoms were monitored using the PANSS and the AIMS, respectively.

External Links

•   Lilly Clinical Trial Registry