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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485823
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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 Intervention Phase
Schizophrenic Disorders
Drug: Olanzapine Hydrochloride
Procedure: Weight Management Program
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • 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.

Enrollment: 48
Study Start Date: December 2002
Study Completion Date: September 2003
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485823

Locations
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
Investigators
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00485823     History of Changes
Other Study ID Numbers: 6696, F1D-KL-S031
Study First Received: June 11, 2007
Last Updated: June 11, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Weight Gain
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on August 28, 2014