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The Effect of a Weight Management Program During Treatment With Olanzapine

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.
ClinicalTrials.gov Identifier: NCT00169702
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 30, 2008
Information provided by:

Study Description
Brief Summary:
The study is a prospective, randomized, open-label study.

Condition or disease Intervention/treatment
Schizophrenia Behavioral: weight management program

Detailed Description:
The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of a Weight Management Program to Prevent Weight Gain and Metabolic Abnormalities During Treatment With the Atypical Neuroleptic Olanzapine: A Randomised Study
Study Start Date : June 2003
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Olanzapine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
standard information
Behavioral: weight management program
12 sessions, psychoeducation
Behavioral: weight management program
2 weekly, 12 sessions, psychoeducational weight management
Active Comparator: Intervention
weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction.
Behavioral: weight management program
12 sessions, psychoeducation

Outcome Measures

Primary Outcome Measures :
  1. difference in mean weight gain [ Time Frame: November 2007 ]

Secondary Outcome Measures :
  1. changes in waist circumference, blood pressure, blood lipids, fasting glucose [ Time Frame: November 2007 ]

Eligibility Criteria

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:

  • Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
  • Ages between 18 and 65
  • Informed consent
  • Weight gain of at least 1.5 kg in the first 4 weeks
  • A sufficient understanding to participate adequately in the weight management program
  • Patients must agree to cooperate with all tests and examinations required by the protocol.
  • Each patient must understand the nature of the study and must sign an informed consent document.

Exclusion Criteria:

  • Serious, unstable somatic illnesses
  • Illnesses associated with weight gain including renal and endocrine diseases
  • Weight change greater than 3 kg in the preceding three months
  • Weight gain less than 1.5 kg in the first 4 weeks
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00169702

Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
Düsseldorf, Rhineland State, Germany, 40629
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Eli Lilly and Company
Else Kröner-Fresenius-Centre for Nutritional Medicine
Technische Universität München
Principal Investigator: Joachim Cordes, MD Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Düsseldorf, Germany
Study Director: Ansgar Klimke, Prof Department of Psychiatry, Offenbach
Study Director: Hans Hauner, Prof Technical University of Munic
More Information

Hauner H, Rohrig K, Hebebrand J, Skurk T. (2003) No evidence for a direct effect of clozapine on fat-cell formation and production of leptin and other fat-cell-derived factors. Mol Psychiatry. 8 (3):258-9. Hauner H. (2001) Current pharmacological approaches to the treatment of obesity. Int J Obes Relat Metab Disord. 25 Suppl 1: 102-6. Cordes J, Agelink MW, Hauner H , Zielasek J. Metabolic syndrome in psychiatric disorders. The World Journal of Biological Psychiatry 2005, 6 Supplement 1: 342

Responsible Party: Cordes, Joachim, Heinrich-Heine University
ClinicalTrials.gov Identifier: NCT00169702     History of Changes
Other Study ID Numbers: F1D-SB-018
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: April 2007

Keywords provided by Heinrich-Heine University, Duesseldorf:
Schizophrenia, weight management programme

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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