The Effect of a Weight Management Program During Treatment With Olanzapine

This study has been completed.

Sponsors and Collaborators:	Heinrich-Heine University, Duesseldorf Lilly Deutschland GmbH Else Kröner-Fresenius-Centre for Nutritional Medicine Technische Universität München
Information provided by:	Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:	NCT00169702

Purpose

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

Condition	Intervention
Schizophrenia	Behavioral: weight management program

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
Intervention: Active Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169702

Locations

Germany, Rhineland State
Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
Düsseldorf, Rhineland State, Germany, 40629

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

Lilly Deutschland GmbH

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:	Heinrich-Heine University ( Cordes, Joachim )
Study ID Numbers:	F1D-SB-018
Study First Received:	September 9, 2005
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00169702
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:

Schizophrenia, weight management programme

Study placed in the following topic categories:

Schizophrenia
Body Weight
Mental Disorders
Olanzapine

Psychotic Disorders
Weight Gain
Congenital Abnormalities
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 13, 2009