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Energy Homeostasis Under Treatment With Atypical Antipsychotics

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
olanzapine
Ziprasidone
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring weight gain, schizophrenia, atypical antipsychotics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Olanzapine

Zpirasidone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in energy homeostasis, food intake, metabolism

Full Information

First Posted
September 7, 2005
Last Updated
September 26, 2008
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00148564
Brief Title
Energy Homeostasis Under Treatment With Atypical Antipsychotics
Official Title
Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders Under Treatment With Atypical Antipsychotics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
weight gain, schizophrenia, atypical antipsychotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Active Comparator
Arm Title
Zpirasidone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
treatment with either Olanzapine or Ziprasidone
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Zeldox
Intervention Description
treatment with either Olanzapine or Ziprasidone
Primary Outcome Measure Information:
Title
Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment
Time Frame
during treatment
Secondary Outcome Measure Information:
Title
Changes in energy homeostasis, food intake, metabolism
Time Frame
during and after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schaefer, MD
Organizational Affiliation
Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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Energy Homeostasis Under Treatment With Atypical Antipsychotics

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