Weight GainPhase 4NCT00191828
A Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme
A Phase 4 study testing olanzapine in people with Weight Gain, run by Eli Lilly and Company at 1 site in Italy.
Trial summary
Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia and moderate to severe manic episode. Olanzapine is among the many antipsychotic agents associated with weight gain . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Gain
- What is being tested?
- olanzapine
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2003to Aug 2005
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients, previously treated with olanzapine as antipsychotic monotherapy, which have shown a weight gain with an increase of BMI >7% (assessed during the routine visits from the beginning of antipsychotic treatment).
- Male or female subjects at least 18 and no more than 65 years of age.
- Subjects must be considered reliable.
- Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol.
- Each patient, (and a patient's legal representative if mandated by local law), must understand the nature of the study and must sign an informed consent document.
Who cannot join
- Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count <500 mm3).
- Prior treatment with any antipsychotic drugs associated to olanzapine.
- Judged clinically to be at significant suicidal or homicidal risk and/or agitated enough to necessitate use of restraints.
Trial locations and contacts
1 site in 1 country.
Italy1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speack with your personal physician.
Sesto Fiorentino, Florence
About this study
Official title: A Prospective/Parallel Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme
Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia and moderate to severe manic episode.
Olanzapine is among the many antipsychotic agents associated with weight gain . The mechanism for antipsychotic drug-related weight gain is not known, although antagonism of serotonin receptors, especially the 5HT2C , and histamine receptors has been hypothesized.
Read more
The purpose of this study is to observe the efficacy of a psychoeducational programme in managing the increased weight as a side effect of the olanzapine treatment.
Interventions to prevent weight gain associated with olanzapine should at least include periodic monitoring and recommendations for changes in diet and physical activity.
This is a phase IV, randomised, parallel study of subjects previously treated with olanzapine as antipsychotic monotherapy, which have shown an increase of B.M.I. >7% from the beginning of antipsychotic treatment (assessed during the routine visits). For the first 12 weeks of the trial approximately 60 outpatients, enrolled in one site during a period of one year, will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine + psychoeducational programme or olanzapine alone. In the following 12 weeks of the study all patients undergo the psychoeducational programme. The efficacy of this programme will be assessed monitoring the mean difference from baseline to endpoint in total body weight and BMI.
- Conditions
- Weight Gain
- Being tested
- olanzapine
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the efficacy of a psychoeducational programme in managing the olanzapine-associated weight gain
Secondary outcomes (1)
To study the physical and chemical changes induced by weight gain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191828
- Sponsor's protocol ID
- 7399
- Other IDs
- F1D-IT-HGLE
- Status last verified
- Jan 2007
- First submitted
- 12 Sep 2005
- Last updated
- 26 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective/Parallel Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme
- ClinicalTrials.gov ID
- NCT00191828
- Acronym / sponsor ID
- 7399
- Conditions
- Weight Gain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Aug 2005
- First posted
- 19 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.
Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia and moderate to severe manic episode.
Olanzapine is among the many antipsychotic agents associated with weight gain . The mechanism for antipsychotic drug-related weight gain is not known, although antagonism of serotonin receptors, especially the 5HT2C , and histamine receptors has been hypothesized.
The purpose of this study is to observe the efficacy of a psychoeducational programme in managing the increased weight as a side effect of the olanzapine treatment.
Interventions to prevent weight gain associated with olanzapine should at least include periodic monitoring and recommendations for changes in diet and physical activity.
This is a phase IV, randomised, parallel study of subjects previously treated with olanzapine as antipsychotic monotherapy, which have shown an increase of B.M.I. >7% from the beginning of antipsychotic treatment (assessed during the routine visits). For the first 12 weeks of the trial approximately 60 outpatients, enrolled in one site during a period of one year, will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine + psychoeducational programme or olanzapine alone. In the following 12 weeks of the study all patients undergo the psychoeducational programme. The efficacy of this programme will be assessed monitoring the mean difference from baseline to endpoint in total body weight and BMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients, previously treated with olanzapine as antipsychotic monotherapy, which have shown a weight gain with an increase of BMI >7% (assessed during the routine visits from the beginning of antipsychotic treatment).
- Male or female subjects at least 18 and no more than 65 years of age.
- Subjects must be considered reliable.
- Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol.
- Each patient, (and a patient's legal representative if mandated by local law), must understand the nature of the study and must sign an informed consent document.
Key exclusion criteria (3 listed)
- Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count <500 mm3).
- Prior treatment with any antipsychotic drugs associated to olanzapine.
- Judged clinically to be at significant suicidal or homicidal risk and/or agitated enough to necessitate use of restraints.
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 |
|---|---|---|
| olanzapine | Drug | – |
Primary outcome
To observe the efficacy of a psychoeducational programme in managing the olanzapine-associated weight gain
1 secondary outcome
To study the physical and chemical changes induced by weight gain
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 26 Jan 2007.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 in people with Weight Gain, run by Eli Lilly and Company at 1 site in Italy.
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 3 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 26 Jan 2007. 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 Italy. 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?
To observe the efficacy of a psychoeducational programme in managing the olanzapine-associated weight gain. 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 26 Jan 2007.