The Effect of a Weight Management Program During Treatment With Olanzapine
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ClinicalTrials.gov Identifier: NCT00169702 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: January 30, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Behavioral: weight management program | Not Applicable |
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 |
Actual Study Completion Date : | July 2007 |

Arm | Intervention/treatment |
---|---|
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
|
- difference in mean weight gain [ Time Frame: November 2007 ]
- changes in waist circumference, blood pressure, blood lipids, fasting glucose [ Time Frame: November 2007 ]

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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

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
Germany | |
Heinrich-Heine-University, Rhineland State Clinics Düsseldorf | |
Düsseldorf, Rhineland State, Germany, 40629 |
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 |
Publications:
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 Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Antiemetics 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 |