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New treatment option for Intellectual Disability
Official title Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability
ClinicalTrials.gov ID: NCT05744479
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for intellectual disability.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- People with IDD (intellectual and developmental disability) have very high rates of obesity and die prematurely from cardiometabolic disease. While antipsychotics contribute to this problem, their use is necessary and appropriate in a significant subgroup of individuals with IDD.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 65
You may be able to join if
- Stable outpatients
- Age 16-65 years
- Diagnosed with an IDD
- On maintenance treatment with an antipsychotic (stable dose for ≥3 months).
- BMI must be ≥30 kg/m2, OR ≥27 kg/m2 with at least one weight-related comorbidity (treated or untreated) such as: hypertension, dyslipidaemia...
You likely can't join if
- Females who are nursing, currently pregnant, or have a positive pregnancy test
- Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, hepatic, renal, or pulmonary disease
- Previous treatment and lack of how well it works or side effects with metformin
- History or diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (TD2) or fasting blood work, HbA1c \> 6.5%
- History of metabolic acidosis or lactic acidosis
- Treatment with weight-lowering agents
See the full eligibility criteria
- Stable outpatients
- Age 16-65 years
- Diagnosed with an IDD
- On maintenance treatment with an antipsychotic (stable dose for ≥3 months).
- BMI must be ≥30 kg/m2, OR ≥27 kg/m2 with at least one weight-related comorbidity (treated or untreated) such as: hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose, OR \>=25 for...
- Females of child-bearing age must be on one of the following regular contraceptives:
- Agree to abstain from sex for the duration of the trial or
- A barrier method of a diaphragm with spermicide and/or Latex condom or
- An oral contraceptive agent, implantable contraceptive or an injectable contraceptive for at least six months prior to entering the study and will continue its use throughout the study, or
- An intrauterine device, or
- Partner has had a vasectomy at least 3 months prior to study start
- Females who are nursing, currently pregnant, or have a positive pregnancy test
- Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, hepatic, renal, or pulmonary disease
- Previous treatment and lack of how well it works or side effects with metformin
- History or diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (TD2) or fasting blood work, HbA1c \> 6.5%
- History of metabolic acidosis or lactic acidosis
- Treatment with weight-lowering agents
- Medications with significant renal impact
- Major medical or surgical event in the preceding 3 months
- Acute suicidal risk.
- Moderate to severe substance use disorder, other than caffein or nicotine use disorder
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.