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

NCT00485823 | Completed Phase 4

• 2 other identifiers: 6696F1D-KL-S031
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenic Disorders

Outcome Measures

Primary Outcomes (1)

• Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group

Secondary Outcomes (3)

• 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.

Interventions

Olanzapine Hydrochloride DRUG

Weight Management Program PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, South Korea

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Schizophrenia

Interventions

olanzapine-fluoxetine combination

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: December 1, 2002
• Study Completion: September 1, 2003
• Last Updated: June 13, 2007

Record last verified: 2007-06

Locations

KR (1)