Not Signed In -
Olanzapine Injection |
Zyprexa Injection |
Clinical Trial: Energy Homoeostasis Under Treatment with Atypical Antipsychotics
This study is currently recruiting patients.
Verified by Charite University, Berlin, Germany September 2005
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Purpose
To evaluate the effects of different atypical antipsychotics on weight changes, energy homoeostasis, metabolism, energy intake as well as activity.
Patients with schizophrenia or schizoaffective disorders will be randomly assigned to be treated with ziprasidone or olanzapine for 24 weeks.
Primary outcome parameter are the weight changes after 24 weeks
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: olanzapine vs. ziprasidone | Phase IV |
MedlinePlus related topics: Schizophrenia
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Energy Homoestasis and Metabolism in Patients with Schizophrenic Disorders Under Treatment with Atypical Antipsychotics
Secondary Outcomes: Changes in energy homoestasis, food intake, metabolism
Expected Total Enrollment: 40
Study start: March 2004
Eligibility
Inclusion Criteria:
- Diagnosis of schizophrenia or related disorders(DSM-IV)
- Indication for long-term treatment with antipsychotics
- BMI between 20 to 30
- Weight changes less than 3kg in the last 3 months before inclusion
- Informed consent
Exclusion Criteria:
- Psychiatric comorbidity
- Depot antipsychotic in the last 2 months
- Antipsychotics in the last 2 weeks
- Treatment with olanzapine, clozapine or ziprasidone in teh last 3 months
- Treatment with drugs, that may lead to weight changes
- Significant endocrine, neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests
- Female subjects during pregnancy and breastfeeding
- Female subjects within childbearing years who were not using adequate birth control
- Patients who are judged by the investigator to be at serious suicide risk
Location and Contact Information
Germany
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy, Berlin, 10117, Germany; Recruiting
Karolina Leopold, MD +49-30-450-517199 karolina.leopold@charite.de
Martin Schaefer, MD, Principal Investigator, Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy
More Information
Last Updated: September 7, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00148564
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
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