Energy Homeostasis Under Treatment With Atypical Antipsychotics

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00148564

Enrollment

Registered

2005-09-08

Start date

2004-03-31

Completion date

2007-06-30

Last updated

2008-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

weight gain, schizophrenia, atypical antipsychotics

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.

Interventions

DRUGolanzapine

treatment with either Olanzapine or Ziprasidone

DRUGZiprasidone

treatment with either Olanzapine or Ziprasidone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment	during treatment

Secondary

Measure	Time frame
Changes in energy homeostasis, food intake, metabolism	during and after treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026