SchizophreniaPhase 4NCT00148564
Energy Homeostasis Under Treatment With Atypical Antipsychotics
A Phase 4 study testing olanzapine and Ziprasidone in people with Schizophrenia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- olanzapine and Ziprasidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2004to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
Berlin, 10117
About this study
Official title: Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders 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.
- Conditions
- Schizophrenia
- Being tested
- olanzapine, Ziprasidone
- Keywords
- weight gain, schizophrenia, atypical antipsychotics
- Medical subject headings
- Schizophrenia, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called Zyprexa
treatment with either Olanzapine or Ziprasidone
ZiprasidoneDrug
Also called Zeldox
treatment with either Olanzapine or Ziprasidone
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Active comparator | Not described Receives: Drug: olanzapine |
| Zpirasidone | Active comparator | Not described Receives: Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment
Measured: during treatment
Secondary outcomes (1)
Changes in energy homeostasis, food intake, metabolism
Measured: during and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionMar 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Martin Schaefer, MD, Principal investigator, Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148564
- Sponsor's protocol ID
- Energy
- Status last verified
- Sep 2008
- First submitted
- 7 Sep 2005
- Last updated
- 29 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders Under Treatment With Atypical Antipsychotics
- ClinicalTrials.gov ID
- NCT00148564
- Acronym / sponsor ID
- Energy
- Conditions
- Schizophrenia
- Keywords
- weight gain, schizophrenia, atypical antipsychotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Active comparator | Drug: olanzapine |
| Zpirasidone | Active comparator | Drug: Ziprasidone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olanzapineAlso: Zyprexatreatment with either Olanzapine or Ziprasidone | Drug | Olanzapine |
| ZiprasidoneAlso: Zeldoxtreatment with either Olanzapine or Ziprasidone | Drug | Zpirasidone |
Primary outcome
Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment
Time frame: during treatment
1 secondary outcome
Changes in energy homeostasis, food intake, metabolism
Time frame: during and after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schaefer, MD principal investigator
Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing olanzapine and Ziprasidone in people with Schizophrenia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment (time frame: during treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2008.