Energy Homeostasis Under Treatment With Atypical Antipsychotics

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00148564
First received: September 7, 2005
Last updated: September 26, 2008
Last verified: September 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Martin Schaefer, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00148564     History of Changes
Other Study ID Numbers: Energy
Study First Received: September 7, 2005
Last Updated: September 26, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Olanzapine
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 19, 2014