The Effect of a Weight Management Program During Treatment With Olanzapine
This study has been completed.
Sponsor:
Heinrich-Heine University, Duesseldorf
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
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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
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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
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 Mental Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on March 02, 2015