Energy Homeostasis Under Treatment With Atypical Antipsychotics
Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders Under Treatment With Atypical Antipsychotics
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the effects of different atypical antipsychotics on weight changes, energy homeostasis, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 schizophrenia
Started Mar 2004
Typical duration for phase_4 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
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedSeptember 29, 2008
September 1, 2008
3 years
September 7, 2005
September 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment
during treatment
Secondary Outcomes (1)
Changes in energy homeostasis, food intake, metabolism
during and after treatment
Study Arms (2)
Olanzapine
ACTIVE COMPARATORZpirasidone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of schizophrenia or related disorders(DSM-IV)
- Indication for long-term treatment with antipsychotics
- BMI between 20 to 30
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
Berlin, 10117, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Schaefer, MD
Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 8, 2005
Study Start
March 1, 2004
Primary Completion
March 1, 2007
Study Completion
June 1, 2007
Last Updated
September 29, 2008
Record last verified: 2008-09