Weight GainPhase 2PREVENTNCT00617240
Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth
A Phase 2 study testing metformin in people with Weight Gain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Weight Gain
- What is being tested?
- metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects will be between the ages of 10 and 17, male or female, any race or ethnicity
- Any SPMI pediatric diagnosis that meets DSM-IV criteria and frequently is treated with a SGA- typically but not limited to psychotic, mood, pervasive developmental, oppositional defiant, and conduct disorders
- SGA-naïve or less than 2 weeks exposure to any SGA, except ziprasidone
- Legal guardian able and willing to give written informed consent
- If competent, subject able and willing to assent for their own participation
Who cannot join
- Previous trial of metformin
- Recommendation for treatment with clozapine or ziprasidone
- Current use of insulin or any oral hypoglycemic agent
- Current use of a medication known to mitigate weight gain - amantidine, histamine (H2) antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine, stimulants (dextroamphetamine, methylphenidate)
- Any current or past diagnosis of an eating disorder
- Diabetes mellitus
Show all 9Show fewer
- Current active thyroid (TSH >18 microIU/ml; T4 total >18 mcg/dl), hepatic (2 LFTs >4x upper limits of normal), renal (serum Creatinine >1.4 mg/dL in females and serum Creatinine >1.5 mg/dL in males), cardiac, gastrointestinal, or adrenal disease
- Current substance abuse/dependence within past 2 weeks; a positive urine tox screen at baseline in the absence of meeting criteria for abuse/dependence will not preclude enrollment.
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Department of Psychiatry
Chapel Hill, North Carolina, 27599
About this study
Official title: Metformin Mitigation of Atypical Antipsychotic-Induced Metabolic Dysregulation in Adolescent Youth
The purpose of this pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with second-generation antipsychotic medication.
Read the detailed description
This is a 24 week, placebo-controlled, random assignment pilot study in which participants will be randomized in a 1:1 ratio to receive either flexible-dose treatment with metformin for 6 months as well as a newly initiated second generation antipsychotic medication or to receive placebo and the newly initiated antipsychotic medication. All subjects will also be provided healthy lifestyle instruction. The study involves monthly visits for the duration of the study. Participants may be treated as inpatients or outpatients throughout the course of the study. Participants will receive a psychiatric evaluation, physical exam, lab work, ECG, medication treatment, and psychiatric care.
The goal is to evaluate the safety and efficacy of means to prevent and treat weight gain and the associated endocrine, metabolic, and inflammatory changes caused by antipsychotic medications. Behavioral treatments to reduce weight gain and metabolic problems after weight gain has occurred have had little impact. Such interventions must be intensive and sustained over months, if not years to be effective. Although basic lifestyle instruction (diet and physical activity) should be the standard of care for all children and adolescents at risk for becoming overweight, pharmacologic interventions may be the best option for substantially augmenting behavioral approaches to weight management.
- Conditions
- Weight Gain
- Being tested
- metformin, placebo
- Keywords
- antipsychotic, metformin, children, adolescents
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
Also called Glucophage
500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks
placeboDrug
500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | metformin in doses from 250mg to 2000mg/day for 26 weeks Receives: Drug: metformin |
| 2 | Placebo comparator | Matched placebo to metformin, doses between 250/0mg and 2000/0mg per day Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 24 in Body Mass Index (BMI)
Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.
Measured: 0-24 weeks
Change From Baseline to Week 24 in Weight
Change in weight is calculated as 24 weeks weight minus the baseline weight.
Measured: 24 weeks
Change From Baseline to Week 24 in Fat Mass
Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.
Measured: 24 weeks
Secondary outcomes (4)
Change From Baseline to Week 24 in Insulin Level
Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level.
Measured: 24 weeks
Change From Baseline to Week 24 in Cholesterol Level
According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline.
Measured: 24 weeks
Change From Baseline to Week 24 in Triglycerides
In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels.
Measured: 24 weeks
Incidence of Metabolic Syndrome
Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Principal investigator, Linmarie Sikich, MD, University of North Carolina, Chapel Hill
- Investigators
- Linmarie Sikich, MD, Principal investigator, Unversity of North Carolina, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617240
- Sponsor's protocol ID
- 05-2992 GCRC-2501
- Acronym
- PREVENT
- Status last verified
- Feb 2014
- First submitted
- 5 Feb 2008
- Last updated
- 11 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Mitigation of Atypical Antipsychotic-Induced Metabolic Dysregulation in Adolescent Youth
- ClinicalTrials.gov ID
- NCT00617240
- Acronym / sponsor ID
- PREVENT / 05-2992 GCRC-2501
- Conditions
- Weight Gain
- Keywords
- antipsychotic, metformin, children, adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- Jan 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 11 Mar 2014
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 pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with second-generation antipsychotic medication.
Detailed description
This is a 24 week, placebo-controlled, random assignment pilot study in which participants will be randomized in a 1:1 ratio to receive either flexible-dose treatment with metformin for 6 months as well as a newly initiated second generation antipsychotic medication or to receive placebo and the newly initiated antipsychotic medication. All subjects will also be provided healthy lifestyle instruction. The study involves monthly visits for the duration of the study. Participants may be treated as inpatients or outpatients throughout the course of the study. Participants will receive a psychiatric evaluation, physical exam, lab work, ECG, medication treatment, and psychiatric care.
The goal is to evaluate the safety and efficacy of means to prevent and treat weight gain and the associated endocrine, metabolic, and inflammatory changes caused by antipsychotic medications. Behavioral treatments to reduce weight gain and metabolic problems after weight gain has occurred have had little impact. Such interventions must be intensive and sustained over months, if not years to be effective. Although basic lifestyle instruction (diet and physical activity) should be the standard of care for all children and adolescents at risk for becoming overweight, pharmacologic interventions may be the best option for substantially augmenting behavioral approaches to weight management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: metforminmetformin in doses from 250mg to 2000mg/day for 26 weeks |
| 2 | Placebo comparator | Drug: placeboMatched placebo to metformin, doses between 250/0mg and 2000/0mg per day |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects will be between the ages of 10 and 17, male or female, any race or ethnicity
- Any SPMI pediatric diagnosis that meets DSM-IV criteria and frequently is treated with a SGA- typically but not limited to psychotic, mood, pervasive developmental, oppositional defiant, and conduct disorders
- SGA-naïve or less than 2 weeks exposure to any SGA, except ziprasidone
- Legal guardian able and willing to give written informed consent
- If competent, subject able and willing to assent for their own participation
Key exclusion criteria (9 listed)
- Previous trial of metformin
- Recommendation for treatment with clozapine or ziprasidone
- Current use of insulin or any oral hypoglycemic agent
- Current use of a medication known to mitigate weight gain - amantidine, histamine (H2) antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine, stimulants (dextroamphetamine, methylphenidate)
- Any current or past diagnosis of an eating disorder
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: Glucophage500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks | Drug | 1 |
| placebo500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks | Drug | 2 |
Primary outcome
Change From Baseline to Week 24 in Body Mass Index (BMI)
Time frame: 0-24 weeks
Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.
Change From Baseline to Week 24 in Weight
Time frame: 24 weeks
Change in weight is calculated as 24 weeks weight minus the baseline weight.
Change From Baseline to Week 24 in Fat Mass
Time frame: 24 weeks
Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.
4 secondary outcomes
Change From Baseline to Week 24 in Insulin Level
Time frame: 24 weeks
Change From Baseline to Week 24 in Cholesterol Level
Time frame: 24 weeks
Change From Baseline to Week 24 in Triglycerides
Time frame: 24 weeks
Incidence of Metabolic Syndrome
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Linmarie Sikich, MD principal investigator
Unversity of North Carolina, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing metformin in people with Weight Gain, run by University of North Carolina, Chapel Hill 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 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 11 Mar 2014. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Week 24 in Body Mass Index (BMI) (time frame: 0-24 weeks). The study lists 3 primary outcomes in all. 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 11 Mar 2014.