Energy Homeostasis Under Treatment With Atypical Antipsychotics
NCT ID: NCT00148564
Last Updated: 2008-09-29
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
PHASE4
40 participants
INTERVENTIONAL
2004-03-31
2007-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Olanzapine
olanzapine
treatment with either Olanzapine or Ziprasidone
Zpirasidone
Ziprasidone
treatment with either Olanzapine or Ziprasidone
Interventions
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olanzapine
treatment with either Olanzapine or Ziprasidone
Ziprasidone
treatment with either Olanzapine or Ziprasidone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Charite University, Berlin, Germany
Principal Investigators
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Martin Schaefer, MD
Role: PRINCIPAL_INVESTIGATOR
Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte
Locations
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Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
Berlin, , Germany
Countries
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Other Identifiers
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Energy
Identifier Type: -
Identifier Source: org_study_id