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CompletedNCT00148564Updated Sep 29, 2008

Energy Homeostasis Under Treatment With Atypical Antipsychotics

A Phase 4 interventional study of olanzapine and Ziprasidone in Schizophrenia, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-09-29.

Sponsored by Charite University, Berlin, Germany · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia

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Keywords

  • weight gain
  • schizophrenia
  • atypical antipsychotics
03

In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Olanzapine

    Drug: olanzapine

  • Active comparator
    Zpirasidone

    Drug: Ziprasidone

Interventions

  • Drugolanzapine

    treatment with either Olanzapine or Ziprasidone

    Also known as: Zyprexa

  • DrugZiprasidone

    treatment with either Olanzapine or Ziprasidone

    Also known as: Zeldox

06

What researchers measure

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

07

Study locations

1 site
  • Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
    Berlin, 10117, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00148564
Lead sponsor
Charite University, Berlin, Germany
First posted
Sep 8, 2005
Start date
Mar 2004
Primary completion
Mar 2007
Completion
Jun 2007
Last update
Sep 29, 2008

Study contacts

Martin Schaefer, MD
principal investigator · Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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