SchizophreniaPhase 4NCT00391261
An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications.
A Phase 4 study testing Metformin in people with Schizophrenia and Schizoaffective Disorder, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
The aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin treatment in children and adolescents suffering from weight gain secondary to use of atypical antipsychotic medications. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- What is being tested?
- Metformin
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Oct 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females aged 10-18 years.
- A DSM-IV diagnosis of bipolar disorder schizophrenia spectrum disorder, or pervasive developmental disorder.
- Ability to give assent.
- At least 10% increase in body mass index (BMI) within the past 2 months of quetiapine, olanzapine, or risperidone treatment, per parent or physician report.
- On stable dose of quetiapine, olanzapine, or risperidone x2 weeks.
- Otherwise medically stable.
Who cannot join
- Subjects meeting criteria for an eating disorder or an autistic spectrum disorder.
- IQ below the mild mental retardation range (<60), based on verified records of cognitive testing performed within 2 years of enrollment. In event that suitable records of prior testing are unavailable, IQ will be estimated based on current classroom placement.
- Significant medical and/or neurological illness, including seizure disorders, severe respiratory illness or cardiac conditions; cerebrovascular disease; hypo- or hypertension; immune, endocrine, renal, or hepatic dysfunction. The definition of such dysfunction will be derived from laboratory normal ranges, such that values lying outside those ranges would be considered abnormal.
- Subjects taking antidepressants.
- Active substance abuse/dependence based upon history and/or urine toxicology tests performed at screening.
- Inability to have blood drawn at baseline, weekly, and termination visits.
Show all 9Show fewer
- Known allergy or hypersensitivity to metformin or its ingredients.
- Recent history of suicidality, suicidal ideation, or suicide attempts.
- Patients clinically unstable on current medication regimen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Medford, Massachusetts, 02155
About this study
Official title: A Prospective Open-label Trial of Metformin for Weight Control of Pediatric Patients on Atypical Antipsychotic Medications.
The aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin treatment in children and adolescents suffering from weight gain secondary to use of atypical antipsychotic medications. In this 12 week, open-label study we will investigate metformin's effects on weight control and/or weight loss. We hypothesize that metformin would prevent further weight gain or lead to weight loss, resulting in amelioration of one of the most significant side effects of atypical antipsychotic use.
Read the detailed description
Patients taking olanzapine, risperidone, or quetiapine with increased BMI of at least 10% over the previous 2 months of atypical therapy will be eligible for the study. Subjects will need to have been on a stable dose of their antipsychotic medications at the time of enrollment (stable x2 weeks) and will remain on the same atypical dose, if possible, throughout the study. The dosing of metformin will start at 500mg per day and increase up to a maximum dose of 1500mg daily. Determination of weight gain during the course of the study will be based on the subject's weight at enrollment and subsequent visits. The patients will be asked not to vary their dietary or physical activity habits during the study.
Interpretation of Data: The study's primary outcome measure will be change in weight and body mass index at 12 weeks of metformin treatment. Additionally, skin-fold test and abdominal girth will be measured at baseline and endpoint.
Risks: Generally, metformin is well-tolerated. However, there may be unknown risks associated with exposure to a new medication in a clinical population where this specific compound has not been studied extensively. The general and rare side effects are listed below. These risks will be minimized by careful monitoring and higher than standard of care safety evaluations. In addition, an individual's symptoms could potentially remain unchanged or worsen by initiating this medication, or from delaying initiation of a potentially more effective alternative treatment. For these reasons, participation in the study is entirely voluntary and consent may be withdrawn at any time without any repercussions and will result in the patient being immediately discontinued from the study. If at any time the clinician believes that the patient is not benefiting from the study, the study will be discontinued and endpoint measures will be obtained if possible. A risk-benefit analysis, weighing clinical improvement against side effects will be done at each visit and will determine further inclusion in the study.
Subjects and their guardians will be asked repeatedly to inform study staff of any side effects. Subjects are informed of the potential side effects and the importance of alerting study staff to the side effects in the consent and assent forms. Side effect data will be collected at baseline and every other week, but subjects are encouraged to give relevant information at every clinical evaluation.
Alternative treatments include no treatment with an attendant risk of increased weight gain, potentially leading to health hazard. Other medications that are available are not extensively used and widely accepted. These other medication options will be discussed as alternatives during the consent process. Also, life-style modifications including healthy diet habits and increased physical activity will be discussed during the consent process as well.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar Disorder, Autism Spectrum Disorders
- Being tested
- Metformin
- Keywords
- weight gain, obesity, metabolism
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Autism Spectrum Disorder, Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
open-label, flexible dosing
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: weekly
Secondary outcomes (1)
MOSES
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2007
- Study completionOct 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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychiatric Association
- Investigators
- Jean A Frazier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391261
- Sponsor's protocol ID
- CHA-IRB-0143/12/05
- Status last verified
- Jun 2008
- First submitted
- 19 Oct 2006
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-label Trial of Metformin for Weight Control of Pediatric Patients on Atypical Antipsychotic Medications.
- ClinicalTrials.gov ID
- NCT00391261
- Acronym / sponsor ID
- CHA-IRB-0143/12/05
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar Disorder, Autism Spectrum Disorders
- Keywords
- weight gain, obesity, metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- American Psychiatric Association
- Study start
- Jul 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Oct 2006 (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 aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin treatment in children and adolescents suffering from weight gain secondary to use of atypical antipsychotic medications. In this 12 week, open-label study we will investigate metformin's effects on weight control and/or weight loss. We hypothesize that metformin would prevent further weight gain or lead to weight loss, resulting in amelioration of one of the most significant side effects of atypical antipsychotic use.
Detailed description
Patients taking olanzapine, risperidone, or quetiapine with increased BMI of at least 10% over the previous 2 months of atypical therapy will be eligible for the study. Subjects will need to have been on a stable dose of their antipsychotic medications at the time of enrollment (stable x2 weeks) and will remain on the same atypical dose, if possible, throughout the study. The dosing of metformin will start at 500mg per day and increase up to a maximum dose of 1500mg daily. Determination of weight gain during the course of the study will be based on the subject's weight at enrollment and subsequent visits. The patients will be asked not to vary their dietary or physical activity habits during the study.
Interpretation of Data: The study's primary outcome measure will be change in weight and body mass index at 12 weeks of metformin treatment. Additionally, skin-fold test and abdominal girth will be measured at baseline and endpoint.
Risks: Generally, metformin is well-tolerated. However, there may be unknown risks associated with exposure to a new medication in a clinical population where this specific compound has not been studied extensively. The general and rare side effects are listed below. These risks will be minimized by careful monitoring and higher than standard of care safety evaluations. In addition, an individual's symptoms could potentially remain unchanged or worsen by initiating this medication, or from delaying initiation of a potentially more effective alternative treatment. For these reasons, participation in the study is entirely voluntary and consent may be withdrawn at any time without any repercussions and will result in the patient being immediately discontinued from the study. If at any time the clinician believes that the patient is not benefiting from the study, the study will be discontinued and endpoint measures will be obtained if possible. A risk-benefit analysis, weighing clinical improvement against side effects will be done at each visit and will determine further inclusion in the study.
Subjects and their guardians will be asked repeatedly to inform study staff of any side effects. Subjects are informed of the potential side effects and the importance of alerting study staff to the side effects in the consent and assent forms. Side effect data will be collected at baseline and every other week, but subjects are encouraged to give relevant information at every clinical evaluation.
Alternative treatments include no treatment with an attendant risk of increased weight gain, potentially leading to health hazard. Other medications that are available are not extensively used and widely accepted. These other medication options will be discussed as alternatives during the consent process. Also, life-style modifications including healthy diet habits and increased physical activity will be discussed during the consent process as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males and females aged 10-18 years.
- A DSM-IV diagnosis of bipolar disorder schizophrenia spectrum disorder, or pervasive developmental disorder.
- Ability to give assent.
- At least 10% increase in body mass index (BMI) within the past 2 months of quetiapine, olanzapine, or risperidone treatment, per parent or physician report.
- On stable dose of quetiapine, olanzapine, or risperidone x2 weeks.
Key exclusion criteria (9 listed)
- Subjects meeting criteria for an eating disorder or an autistic spectrum disorder.
- IQ below the mild mental retardation range (<60), based on verified records of cognitive testing performed within 2 years of enrollment. In event that suitable records of prior testing are unavailable, IQ will be estimated based on current classroom placement.
- Significant medical and/or neurological illness, including seizure disorders, severe respiratory illness or cardiac conditions; cerebrovascular disease; hypo- or hypertension; immune, endocrine, renal, or hepatic dysfunction. The definition of such dysfunction will be derived from laboratory normal ranges, such that values lying outside those ranges would be considered abnormal.
- Subjects taking antidepressants.
- Active substance abuse/dependence based upon history and/or urine toxicology tests performed at screening.
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 |
|---|---|---|
| MetforminAlso: Glucophageopen-label, flexible dosing | Drug | – |
Primary outcome
BMI
Time frame: weekly
1 secondary outcome
MOSES
Time frame: weekly
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 25 Mar 2010.
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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.
Jean A Frazier, MD principal investigator
Cambridge Health Alliance
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 Metformin in people with Schizophrenia and Schizoaffective Disorder, run by Cambridge Health Alliance at 1 site in United States.
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 6 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 25 Mar 2010. 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 United States. 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?
BMI (time frame: weekly). 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 25 Mar 2010.