SchizophreniaNCT00169702
The Effect of a Weight Management Program During Treatment With Olanzapine
A study testing weight management program in people with Schizophrenia, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The study is a prospective, randomized, open-label study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- weight management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2003to Jul 2007
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
- Ages between 18 and 65
- Informed consent
- Weight gain of at least 1.5 kg in the first 4 weeks
- A sufficient understanding to participate adequately in the weight management program
- Patients must agree to cooperate with all tests and examinations required by the protocol.
- Each patient must understand the nature of the study and must sign an informed consent document.
Who cannot join
- Serious, unstable somatic illnesses
- Illnesses associated with weight gain including renal and endocrine diseases
- Weight change greater than 3 kg in the preceding three months
- Weight gain less than 1.5 kg in the first 4 weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
Düsseldorf, Rhineland State, 40629
About this study
Official title: The Effect of a Weight Management Program to Prevent Weight Gain and Metabolic Abnormalities During Treatment With the Atypical Neuroleptic Olanzapine: A Randomised Study
The study is a prospective, randomized, open-label study.
Read the detailed description
The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.
- Conditions
- Schizophrenia
- Being tested
- weight management program
- Keywords
- Schizophrenia, weight management programme
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight management programBehavioural
12 sessions, psychoeducation
weight management programBehavioural
2 weekly, 12 sessions, psychoeducational weight management
| Study group | Role | What they receive |
|---|---|---|
| Standard | Other | standard information Receives: Behavioral: weight management program |
| Intervention | Active comparator | weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction. Receives: Behavioral: weight management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in mean weight gain
Measured: November 2007
Secondary outcomes (1)
changes in waist circumference, blood pressure, blood lipids, fasting glucose
Measured: November 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2003
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Else Kröner Fresenius Foundation, Technical University of Munich
- Investigators
- Joachim Cordes, MD, Principal investigator, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Düsseldorf, GermanyAnsgar Klimke, Prof, Study director, Department of Psychiatry, OffenbachHans Hauner, Prof, Study director, Technical University of Munic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169702
- Sponsor's protocol ID
- F1D-SB-018
- Status last verified
- Apr 2007
- First submitted
- 9 Sep 2005
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Hauner H, Rohrig K, Hebebrand J, Skurk T. No evidence for a direct effect of clozapine on fat-cell formation and production of leptin and other fat-cell-derived factors. Mol Psychiatry. 2003 Mar;8(3):258-9. doi: 10.1038/sj.mp.4001246. No abstract available.
PubMed 12660797
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Weight Management Program to Prevent Weight Gain and Metabolic Abnormalities During Treatment With the Atypical Neuroleptic Olanzapine: A Randomised Study
- ClinicalTrials.gov ID
- NCT00169702
- Acronym / sponsor ID
- F1D-SB-018
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, weight management programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Else Kröner Fresenius Foundation, Technical University of Munich
- Study start
- Jun 2003
- Study completion
- Jul 2007 (actual)
- First posted
- 15 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 study is a prospective, randomized, open-label study.
Detailed description
The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Other | Behavioral: weight management programstandard information |
| Intervention | Active comparator | Behavioral: weight management programweight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
- Ages between 18 and 65
- Informed consent
- Weight gain of at least 1.5 kg in the first 4 weeks
- A sufficient understanding to participate adequately in the weight management program
Key exclusion criteria (4 listed)
- Serious, unstable somatic illnesses
- Illnesses associated with weight gain including renal and endocrine diseases
- Weight change greater than 3 kg in the preceding three months
- Weight gain less than 1.5 kg in the first 4 weeks
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 |
|---|---|---|
| weight management program12 sessions, psychoeducation | Behavioural | Intervention, Standard |
| weight management program2 weekly, 12 sessions, psychoeducational weight management | Behavioural | Standard |
Primary outcome
difference in mean weight gain
Time frame: November 2007
1 secondary outcome
changes in waist circumference, blood pressure, blood lipids, fasting glucose
Time frame: November 2007
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 30 Jan 2008.
- Background: PubMed 12660797Hauner H, Rohrig K, Hebebrand J, Skurk T. No evidence for a direct effect of clozapine on fat-cell formation and production of leptin and other fat-cell-derived factors. Mol Psychiatry. 2003 Mar;8(3):258-9. doi: 10.1038/sj.mp.4001246. No abstract available.
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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.
Joachim Cordes, MD principal investigator
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Düsseldorf, Germany
Ansgar Klimke, Prof study director
Department of Psychiatry, Offenbach
Hans Hauner, Prof study director
Technical University of Munic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight management program in people with Schizophrenia, run by Heinrich-Heine University, Duesseldorf 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 7 inclusion and 4 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 30 Jan 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.
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?
difference in mean weight gain (time frame: November 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169702, which also lists 1 linked publication.
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 30 Jan 2008.