Skip to main content
OpenTrials
Completed

NCT Number: NCT00148564

Energy Homeostasis Under Treatment With Atypical Antipsychotics

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Body Weight Body Weight Changes Mental Disorders Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Weight Gain

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

treatment with either Olanzapine or Ziprasidone

Other names: Zyprexa

Ziprasidone

Drug

treatment with either Olanzapine or Ziprasidone

Other names: Zeldox

Primary outcomes

  1. Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment

    Time frame: during treatment

Secondary outcomes

  1. Changes in energy homeostasis, food intake, metabolism

    Time frame: during and after treatment

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders Under Treatment With Atypical Antipsychotics

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 8, 2005
Registry last updated
Sep 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.