The Effect of a Weight Management Program During Treatment With Olanzapine
NCT ID: NCT00169702
Last Updated: 2008-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2003-06-30
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard
standard information
weight management program
12 sessions, psychoeducation
weight management program
2 weekly, 12 sessions, psychoeducational weight management
Intervention
weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction.
weight management program
12 sessions, psychoeducation
Interventions
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weight management program
12 sessions, psychoeducation
weight management program
2 weekly, 12 sessions, psychoeducational weight management
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Else Kröner-Fresenius-Centre for Nutritional Medicine
UNKNOWN
Technical University of Munich
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Heinrich-Heine University
Principal Investigators
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Joachim Cordes, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Düsseldorf, Germany
Ansgar Klimke, Prof
Role: STUDY_DIRECTOR
Department of Psychiatry, Offenbach
Hans Hauner, Prof
Role: STUDY_DIRECTOR
Technical University of Munic
Locations
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Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
Düsseldorf, Rhineland State, Germany
Countries
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References
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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.
Other Identifiers
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F1D-SB-018
Identifier Type: -
Identifier Source: org_study_id