The Effect of a Weight Management Program During Treatment With Olanzapine

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Else Kröner-Fresenius-Centre for Nutritional Medicine
Technische Universität München
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00169702
First received: September 9, 2005
Last updated: January 28, 2008
Last verified: April 2007
  Purpose

The study is a prospective, randomized, open-label study.


Condition Intervention
Schizophrenia
Behavioral: weight management program

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

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • difference in mean weight gain [ Time Frame: November 2007 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • changes in waist circumference, blood pressure, blood lipids, fasting glucose [ Time Frame: November 2007 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: June 2003
Study Completion Date: July 2007
Arms Assigned Interventions
Standard
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00169702

Locations
Germany
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
Investigators
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

Publications:
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
Study First Received: September 9, 2005
Last Updated: January 28, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
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 September 14, 2014