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Metformin for Antipsychotic-Induced Weight Gain in Intellectual Disability (METIDD Trial)

Phase 4
Recruiting
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years
Diagnosed with IDD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 4, 8, 12, 16, 10, 24
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial aims to study the effectiveness of a medication called metformin in helping overweight or obese adults with intellectual and developmental disabilities (IDD) who have gained weight due to taking antipsychotic medications

Who is the study for?
Adults aged 18-65 with intellectual and developmental disabilities (IDD) who are obese due to antipsychotic medications can join. They must have been on a stable dose of antipsychotics for at least 3 months, have a BMI ≥30 or ≥27 with weight-related health issues like high blood pressure. Participants should either abstain from sex or use reliable contraception during the trial.
What is being tested?
The study is testing if Metformin helps reduce weight gain caused by antipsychotic drugs in adults with IDD. It's the first study of its kind and will compare Metformin's effects against a placebo while participants also receive lifestyle advice.
What are the potential side effects?
Metformin may cause side effects such as stomach upset, diarrhea, nausea, and loss of appetite. Some people might experience changes in taste or mild rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with an intellectual developmental disorder.
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My BMI is over 30, or over 27 with a condition like high blood pressure or sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 4, 8, 12, 16, 10, 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 4, 8, 12, 16, 10, 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Individual's percentage change in body weight
Secondary study objectives
Between group (metformin vs placebo) absolute change in weight
Between group absolute change in BMI
Between group absolute change in waist circumference
+9 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Metformin (Oral)Experimental Treatment2 Interventions
50 participants will be administered oral metformin titrated to a maximum dose of 2000mg/day for 24 weeks.
Group II: PlaceboPlacebo Group2 Interventions
50 participants will be administered an identical oral placebo for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Intervention
2001
Completed Phase 3
~8370
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
375 Previous Clinical Trials
82,787 Total Patients Enrolled
~33 spots leftby Dec 2025
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