The Effect of a Weight Management Program During Treatment With Olanzapine
1 other identifier
interventional
100
1 country
1
Brief Summary
The study is a prospective, randomized, open-label study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Jun 2003
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJanuary 30, 2008
April 1, 2007
September 9, 2005
January 28, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
difference in mean weight gain
November 2007
Secondary Outcomes (1)
changes in waist circumference, blood pressure, blood lipids, fasting glucose
November 2007
Study Arms (2)
Standard
OTHERstandard information
Intervention
ACTIVE COMPARATORweight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heinrich-Heine University, Duesseldorflead
- Eli Lilly and Companycollaborator
- Else Kröner-Fresenius-Centre for Nutritional Medicinecollaborator
- Technical University of Munichcollaborator
Study Sites (1)
Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
Düsseldorf, Rhineland State, 40629, Germany
Related Publications (1)
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.
PMID: 12660797BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
June 1, 2003
Study Completion
July 1, 2007
Last Updated
January 30, 2008
Record last verified: 2007-04