Energy Homeostasis Under Treatment With Atypical Antipsychotics

Charite University, Berlin, Germany40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

olanzapineDRUG

treatment with either Olanzapine or Ziprasidone

ZiprasidoneDRUG

treatment with either Olanzapine or Ziprasidone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Berlin, Germany

Outcomes

Primary Outcomes

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

Time frame: during treatment

Secondary Outcomes

Changes in energy homeostasis, food intake, metabolism

Time frame: during and after treatment

Data from ClinicalTrials.gov

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