Back to resultsThe Effect of a Weight Management Program During Treatment With Olanzapine
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
weight management program
weight management program
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, weight management programme
Eligibility 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
Sites / Locations
- Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Standard
Intervention
Arm Description
standard information
weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction.
Outcomes
Primary Outcome Measures
difference in mean weight gain
Secondary Outcome Measures
changes in waist circumference, blood pressure, blood lipids, fasting glucose
Full Information
NCT ID
NCT00169702
First Posted
September 9, 2005
Last Updated
January 28, 2008
Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
Eli Lilly and Company, Else Kröner-Fresenius-Centre for Nutritional Medicine, Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00169702
Brief Title
The Effect of a Weight Management Program During Treatment With Olanzapine
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 Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
Eli Lilly and Company, Else Kröner-Fresenius-Centre for Nutritional Medicine, Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a prospective, randomized, open-label study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, weight management programme
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
Other
Arm Description
standard information
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction.
Intervention Type
Behavioral
Intervention Name(s)
weight management program
Intervention Description
12 sessions, psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
weight management program
Intervention Description
2 weekly, 12 sessions, psychoeducational weight management
Primary Outcome Measure Information:
Title
difference in mean weight gain
Time Frame
November 2007
Secondary Outcome Measure Information:
Title
changes in waist circumference, blood pressure, blood lipids, fasting glucose
Time Frame
November 2007
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Cordes, MD
Organizational Affiliation
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Düsseldorf, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ansgar Klimke, Prof
Organizational Affiliation
Department of Psychiatry, Offenbach
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hans Hauner, Prof
Organizational Affiliation
Technical University of Munic
Official's Role
Study Director
Facility Information:
Facility Name
Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
City
Düsseldorf
State/Province
Rhineland State
ZIP/Postal Code
40629
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
12660797
Citation
Hauner H, Rohrig 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. doi: 10.1038/sj.mp.4001246. No abstract available.
Results Reference
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The Effect of a Weight Management Program During Treatment With Olanzapine
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