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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485823
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : June 13, 2007
Information provided by:
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Schizophrenic Disorders Drug: Olanzapine Hydrochloride Procedure: Weight Management Program Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2002
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group

Secondary Outcome Measures :
  1. Mean change from baseline to endpoint in the Stunkard and Messick Eating Inventory
  2. Measure safety parameters, including medical history, psychiatric and physical examinations, vital signs (blood pressure, pulse and weight), clinical laboratory tests and record of symptoms
  3. Severity of psychiatric symptoms and extrapyramidal symptoms were monitored using the PANSS and the AIMS, respectively.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00485823

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, Korea, Republic of
Sponsors and Collaborators
Eli Lilly and Company
Study Director: 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

Additional Information: Identifier: NCT00485823     History of Changes
Other Study ID Numbers: 6696
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: June 13, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Weight Gain
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents