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

History of Changes

Purpose

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

Condition	Intervention
Schizophrenia	Behavioral: weight management program


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Body Weight Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

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

Primary Outcome Measures:

difference in mean weight gain [ Time Frame: November 2007 ]

Secondary Outcome Measures:

changes in waist circumference, blood pressure, blood lipids, fasting glucose [ Time Frame: November 2007 ]


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 (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

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

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

ClinicalTrials.gov processed this record on August 18, 2017

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