Status:
COMPLETED
The Effect of a Weight Management Program During Treatment With Olanzapine
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
Eli Lilly and Company
Else Kröner-Fresenius-Centre for Nutritional Medicine
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
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 subjecti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00169702
Start Date
June 1 2003
End Date
July 1 2007
Last Update
January 30 2008
Active Locations (1)
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1
Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
Düsseldorf, Rhineland State, Germany, 40629