OverweightPhase 3METNCT01825798

Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)

A Phase 3 study testing Metformin in people with Overweight and Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether metformin is safe and effective in the treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who are currently taking atypical antipsychotic medication. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Overweight, Autism Spectrum Disorder
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: 60 participants
Where: 4 sitesin 2 countries
Study dates: Apr 2013to Oct 2015
Phase: Phase 3
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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosis of Autism Spectrum Disorder (autistic disorder, pervasive developmental disorder not otherwise specified), Asperger's disorder) based upon an Autism Diagnostic Observation Scale (ADOS) and Diagnostic and Statistical Manual (DSM-IV) interview.
Minimum of 1 month on a stable atypical antipsychotic dose with no plans to change the dose for the next 4 months.
A documented greater than/equal to 7% increase in BMI since starting atypical antipsychotic therapy(going back as far as prior 12 months); or, if BMI is greater or equal to 85th percentile corrected for age and sex, then a greater than 5% body weight increase per year (prorated at greater than 5% body weight increase if medicated for longer than a year).
Age 6 years to 17 years, 4 months.
Subjects and their parents (guardians) must be judged reliable for medication compliance and must agree to keep appointments for study visits and tests as outlined in the protocol.
Prior to the conduct of any study-specific procedures, the subject must provide assent to participate in the study (if developmentally appropriate), and their parents (guardians) must provide written informed consent.

Who cannot join

History of intolerable adverse effects with metformin.
Prior history of an exposure to metformin of sufficient dose or duration to determine response status.
History of liver disease, renal impairment, congestive heart failure, pernicious anemia, any other condition increasing the risk for lactic acidosis, or any serious medical illness requiring treatment.
Use of cationic drugs excreted by the kidneys.
Planned surgery or procedure requiring contrast.
Pregnant at screening contact.

Show all 11Show fewer

On other psychotropic concomitant medications for less than 2 months.
Treatment or planned treatment with concomitant medications with unacceptable interactions with metformin, including topiramate, levetiracetam, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, diuretics, or histamine H2 receptor antagonists.
Unable to tolerate blood work.
Current use of medication for target symptoms of appetite or weight loss.
Planned change of medication, medication dose, or behavioral treatment targeting weight loss during the study period.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States3 sites

Ohio State University/Nationwide Children's Hospital
Columbus, Ohio, 43210
Vanderbilt University
Nashville, Tennessee, 37212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15203

Other trials in United States

Canada1 site

Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8

Other trials in Canada

About this study

Read the detailed description

This is a double-blind, placebo-controlled, multi-site randomized trial to evaluate oral fixed dose metformin (Riomet®) in decreasing weight or weight gain in children ages 6-17 years, 4 months with ASD who are currently taking atypical antipsychotic medication. A 16-week, double-blind, placebo-controlled randomized trial of metformin with dose guided by age will be conducted. A secondary study aim will be to assess the long-term safety and efficacy of metformin by conducting a 16-week open label continuation.

Conditions: Overweight, Autism Spectrum Disorder
Being tested: Metformin, Placebo
Keywords: Metformin, Overweight, Atypical Antipsychotic, Medication, Randomized Clinical Trial, Children
Medical subject headings: Overweight, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetforminDrug
Also called Riomet
Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
PlaceboDrug
The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.

Study groups in NCT01825798
Study group	Role	What they receive
Placebo Hydrochloride Oral Solution	Placebo comparator	Not described Receives: Drug: Placebo
Metformin	Experimental	Not described Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Body Mass Index Z-score
Measured: Baseline, 16 Weeks

Secondary outcomes (11)

Changes in Additional Body Composition Parameters (Absolute Change in Weight)
Measured: Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Relative Change in Weight)
Measured: Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Absolute BMI)
Measured: Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Abdominal Circumference)
Measured: Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Hip Circumference)
Measured: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Total Cholesterol)
Measured: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (LDL)
Measured: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (HDL)
Measured: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Triglycerides)
Measured: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Glucose)
Measured: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Insulin)
Measured: Baseline, 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Oct 2015

First posted8 Apr 2013 (estimated)
Study startApr 2013
Primary completionJun 2015
Study completionOct 2015

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for OverweightStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01825798
Sponsor's protocol ID: MET-10-2012
Acronym: MET
Status last verified: Jan 2018
First submitted: 7 Feb 2013
Last updated: 16 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Handen BL, Anagnostou E, Aman MG, Sanders KB, Chan J, Hollway JA, Brian J, Arnold LE, Capano L, Williams C, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Peleg N, Odrobina D, McAuliffe-Bellin S, Marler S, Wong T, Wagner A, Hadjiyannakis S, Macklin EA, Veenstra-VanderWeele J. A Randomized, Placebo-Controlled Trial of Metformin for the Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorder: Open-Label Extension. J Am Acad Child Adolesc Psychiatry. 2017 Oct;56(10):849-856.e6. doi: 10.1016/j.jaac.2017.07.790. Epub 2017 Aug 19.
PubMed 28942807
Anagnostou E, Aman MG, Handen BL, Sanders KB, Shui A, Hollway JA, Brian J, Arnold LE, Capano L, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Hadjiyannakis S, Peleg N, Odrobina D, McAuliffe-Bellin S, Zakroysky P, Marler S, Wagner A, Wong T, Macklin EA, Veenstra-VanderWeele J. Metformin for Treatment of Overweight Induced by Atypical Antipsychotic Medication in Young People With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Sep 1;73(9):928-37. doi: 10.1001/jamapsychiatry.2016.1232.
PubMed 27556593

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Overweight trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
ClinicalTrials.gov ID: NCT01825798
Acronym / sponsor ID: MET / MET-10-2012
Conditions: Overweight, Autism Spectrum Disorder
Keywords: Metformin, Overweight, Atypical Antipsychotic, Medication, Randomized Clinical Trial, Children
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
Collaborators: Massachusetts General Hospital, Vanderbilt University, University of Pittsburgh Medical Center, Nationwide Children's Hospital, Ohio State University
Study start: Apr 2013
Primary completion: Jun 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 8 Apr 2013 (estimated)
Results: Posted 22 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo Hydrochloride Oral Solution	Placebo comparator	Drug: Placebo
Metformin	Experimental	Drug: Metformin

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Diagnosis of Autism Spectrum Disorder (autistic disorder, pervasive developmental disorder not otherwise specified), Asperger's disorder) based upon an Autism Diagnostic Observation Scale (ADOS) and Diagnostic and Statistical Manual (DSM-IV) interview.
Minimum of 1 month on a stable atypical antipsychotic dose with no plans to change the dose for the next 4 months.
A documented greater than/equal to 7% increase in BMI since starting atypical antipsychotic therapy(going back as far as prior 12 months); or, if BMI is greater or equal to 85th percentile corrected for age and sex, then a greater than 5% body weight increase per year (prorated at greater than 5% body weight increase if medicated for longer than a year).
Age 6 years to 17 years, 4 months.
Subjects and their parents (guardians) must be judged reliable for medication compliance and must agree to keep appointments for study visits and tests as outlined in the protocol.

Key exclusion criteria (11 listed)

History of intolerable adverse effects with metformin.
Prior history of an exposure to metformin of sufficient dose or duration to determine response status.
History of liver disease, renal impairment, congestive heart failure, pernicious anemia, any other condition increasing the risk for lactic acidosis, or any serious medical illness requiring treatment.
Use of cationic drugs excreted by the kidneys.
Planned surgery or procedure requiring contrast.

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: RiometMetformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.	Drug	Metformin
PlaceboThe placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.	Drug	Placebo Hydrochloride Oral Solution

Primary outcome

Change in Body Mass Index Z-score
Time frame: Baseline, 16 Weeks

11 secondary outcomes

Changes in Additional Body Composition Parameters (Absolute Change in Weight)
Time frame: Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Relative Change in Weight)
Time frame: Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Absolute BMI)
Time frame: Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Abdominal Circumference)
Time frame: Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Hip Circumference)
Time frame: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Total Cholesterol)
Time frame: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (LDL)
Time frame: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (HDL)
Time frame: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Triglycerides)
Time frame: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Glucose)
Time frame: Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Insulin)
Time frame: Baseline, 16 Weeks

Results and safety

Results posted to the registry on 22 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Hydrochloride Oral Solution	32	30
Metformin	28	23

Primary outcome: Change in Body Mass Index Z-score

Time frame: Baseline, 16 Weeks. Mean (95% Confidence Interval). Unit: 16-wk change in BMI z-score

Measure	Placebo Hydrochloride Oral Solution n = 32	Metformin n = 28
Value	0.02 (-0.03 to 0.06)	-0.08 (-0.13 to -0.04)

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Hydrochloride Oral Solution	1 of 32 (3.1%)	32 of 32 (100%)	Not reported
Metformin	0 of 28 (0%)	28 of 28 (100%)	Not reported

Limitations and caveats (from the sponsor): Treatment length doesn't capture metabolic benefits. Unable to evaluate maintenance of initial improvements. Limited information on length of overall exposure to antipsychotic medications. No evaluation on benefit of lifestyle.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28942807Handen BL, Anagnostou E, Aman MG, Sanders KB, Chan J, Hollway JA, Brian J, Arnold LE, Capano L, Williams C, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Peleg N, Odrobina D, McAuliffe-Bellin S, Marler S, Wong T, Wagner A, Hadjiyannakis S, Macklin EA, Veenstra-VanderWeele J. A Randomized, Placebo-Controlled Trial of Metformin for the Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorder: Open-Label Extension. J Am Acad Child Adolesc Psychiatry. 2017 Oct;56(10):849-856.e6. doi: 10.1016/j.jaac.2017.07.790. Epub 2017 Aug 19.
Derived from this study: PubMed 27556593Anagnostou E, Aman MG, Handen BL, Sanders KB, Shui A, Hollway JA, Brian J, Arnold LE, Capano L, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Hadjiyannakis S, Peleg N, Odrobina D, McAuliffe-Bellin S, Zakroysky P, Marler S, Wagner A, Wong T, Macklin EA, Veenstra-VanderWeele J. Metformin for Treatment of Overweight Induced by Atypical Antipsychotic Medication in Young People With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Sep 1;73(9):928-37. doi: 10.1001/jamapsychiatry.2016.1232.

Related trials for Overweight

RecruitingObservational study
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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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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.

Evdokia Anagnostou, M.D. principal investigator

Holland Bloorview Kids Rehabilitation Hospital

Jeremey Veenstra-VanderWeele, M.D. principal investigator

Columbia University

Benjamin Handen, Ph.D. principal investigator

University of Pittsburgh Medical Center

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin in people with Overweight and Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 4 sites in 2 countries.

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 11 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Feb 2018). 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 in Body Mass Index Z-score (time frame: Baseline, 16 Weeks). 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 NCT01825798, which also lists 2 linked publications.

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 16 Jul 2025.