Energy Homeostasis Under Treatment With Atypical Antipsychotics

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. Identifier: NCT00148564
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 29, 2008
Information provided by:
Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: olanzapine Drug: Ziprasidone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : March 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : June 2007

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00148564

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

Responsible Party: Martin Schaefer, MD, Charite University, Berlin, Germany Identifier: NCT00148564     History of Changes
Other Study ID Numbers: Energy
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 29, 2008
Last Verified: September 2008

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

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
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