The Effect of a Weight Management Program During Treatment With Olanzapine

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Behavioral: weight management program	Not Applicable

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

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	September 15, 2005
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