The Effect of a Weight Management Program During Treatment With Olanzapine

• Sponsor: Heinrich-Heine University, Duesseldorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT00169702
• Collaborator: Eli Lilly and Company (Industry), Else Kröner-Fresenius-Centre for Nutritional Medicine (Other), Technische Universität München (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Behavioral: weight management program; Behavioral: weight management program	N/A

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

• Study Type: Interventional
• 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: Jun 1, 2003
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Primary Outcome Measures

1. difference in mean weight gain [November 2007]

Secondary Outcome Measures

1. changes in waist circumference, blood pressure, blood lipids, fasting glucose [November 2007]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hauner H, Röhrig K, Hebebrand J, Skurk T. No evidence for a direct effect of clozapine on fat-cell formation and production of leptin and other fat-cell-derived factors. Mol Psychiatry. 2003 Mar;8(3):258-9.

• ClinicalTrials.gov Identifier: NCT00169702
• Other Study ID Numbers: F1D-SB-018
• First Posted: Sep 15, 2005
• Last Update Posted: Jan 30, 2008
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: Schizophrenia, weight management programme
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Jan 30, 2008