The Effect of a Weight Management Program During Treatment With Olanzapine
Not Applicable
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00169702
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method difference in mean weight gain November 2007
- Secondary Outcome Measures
Name Time Method changes in waist circumference, blood pressure, blood lipids, fasting glucose November 2007
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link olanzapine-induced weight gain to metabolic abnormalities in schizophrenia patients?
How does the weight management program in NCT00169702 compare to standard-of-care interventions for olanzapine-related metabolic side effects?
Are there specific biomarkers that identify schizophrenia patients at higher risk for olanzapine-induced weight gain?
What adverse events are commonly associated with olanzapine treatment and how does the weight management program mitigate them?
What combination therapies or alternative atypical antipsychotics show better metabolic profiles compared to olanzapine in schizophrenia management?
Trial Locations
- Locations (1)
Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
🇩🇪Düsseldorf, Rhineland State, Germany
Heinrich-Heine-University, Rhineland State Clinics Düsseldorf🇩🇪Düsseldorf, Rhineland State, Germany