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Energy Homeostasis Under Treatment With Atypical Antipsychotics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148564
First Posted: September 8, 2005
Last Update Posted: September 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  Purpose

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.


Condition Intervention Phase
Schizophrenia Drug: olanzapine Drug: Ziprasidone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders Under Treatment With Atypical Antipsychotics

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment [ Time Frame: during treatment ]

Secondary Outcome Measures:
  • Changes in energy homeostasis, food intake, metabolism [ Time Frame: during and after treatment ]

Enrollment: 40
Study Start Date: March 2004
Study Completion Date: June 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Olanzapine Drug: olanzapine
treatment with either Olanzapine or Ziprasidone
Other Name: Zyprexa
Active Comparator: Zpirasidone Drug: Ziprasidone
treatment with either Olanzapine or Ziprasidone
Other Name: Zeldox

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148564


Locations
Germany
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Martin Schaefer, MD Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte
  More Information

Responsible Party: Martin Schaefer, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00148564     History of Changes
Other Study ID Numbers: Energy
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: September 29, 2008
Last Verified: September 2008

Keywords provided by Charite University, Berlin, Germany:
weight gain
schizophrenia
atypical antipsychotics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Olanzapine
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents