Metformin for early comorbid glucose dysregulation and schizophrenia spectrum disorders: a pilot double-blind randomized clinical trial
Open accessAbstract
Patients with schizophrenia have exceedingly high rates of metabolic comorbidity including type 2 diabetes and lose 15-20 years of life due to cardiovascular diseases, with early accrual of cardiometabolic disease. In this study, thirty overweight or obese (Body Mass Index (BMI) > 25) participants under 40 years old with schizophrenia spectrum disorders and early comorbid prediabetes or type 2 diabetes receiving antipsychotic medications were randomized, in a double-blind fashion, to metformin 1500 mg/day or placebo (2:1 ratio; n = 21 metformin and n = 9 placebo) for 4 months. The primary outcome measures were improvements in glucose homeostasis (HbA1c, fasting glucose) and insulin resistance (Matsuda index-derived from oral glucose tolerance tests and homeostatic model of insulin resistance (HOMA-IR)). Secondary outcome measures included changes in weight, MRI measures of fat mass and distribution, symptom severity, cognition, and hippocampal volume. Twenty-two patients (n = 14 metformin; n = 8 placebo) completed the trial. The metformin group had a significant decrease over time in the HOMA-IR (p = 0.043) and fasting blood glucose (p = 0.007) vs. placebo. There were no differences between treatment groups in the Matsuda index, HbA1c, which could suggest liver-specific effects of metformin. There were no between group differences in other secondary outcome measures, while weight loss in the metformin arm correlated significantly with decreases in subcutaneous, but not visceral or hepatic adipose tissue. Our results show that metformin improved dysglycemia and insulin sensitivity, independent of weight loss, in a young population with prediabetes/diabetes and psychosis spectrum illness, that is at extremely high risk of early cardiovascular mortality. Trial Registration: This protocol was registered with clinicaltrials.gov (NCT02167620).
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Metformin is recommended across treatment guidelines for the prevention and management of antipsychotic-induced weight gain.
“At present, metformin, which is considered the first-line treatment for T2D globally, has shown evidence in the prevention and management of AIWG among patients, and is now recommended across treatment guidelines for this indication.14–17”
From The Effect of Semaglutide on Antipsychotic-Induced Weight Gain and Other Metabolic Parameters, among a Cohort of Inpatients (2026) · cites this paper as [17]
The Introduction says metformin has evidence for antipsychotic-related weight gain and is recommended for that indication in the Canadian Obesity Guidelines, alongside lifestyle modification. It does not establish that metformin is recommended across multiple treatment guidelines or that those guidelines recommend it specifically for prevention as well as management. (LLM, conf=0.87)
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- Authors
- Agarwal, S. M., Panda, R., Costa-Dookhan, K. A., MacKenzie, N. E., Treen, Q. C., Caravaggio, F., Hashim, E., Leung, G., Kirpalani, A., Matheson, K., Chintoh, A. F., Kramer, C. K., Voineskos, A. N., Graff-Guerrero, A., Remington, G. J., & Hahn, M. K.
- Affiliations
- Centre for Addiction and Mental Health (CA)
- St. Michael's Hospital (CA)
- Mount Sinai Hospital (CA)
- Corresponding author
- Hahn, Margaret K.
- ORCID
- Venue
- Translational Psychiatry
- Published
- 2021-04-14
- Volume
- 11
- Issue
- 1
- Pages
- 219-219
- ISSN
- 2158-3188 (ISSN-L)
- PMC
- PMC8046796
- OpenAlex
- W3153610861
- Cited by
- 41
- References
- 42
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 10 · 2023: 8 · 2022: 6 · 2021: 1
- FWCI
- 4.48
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Translational Psychiatry (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Slaight Family Foundation Grant Award
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- metformin, schizophrenia spectrum disorders, prediabetes, type 2 diabetes, insulin resistance, glucose dysregulation, cardiometabolic comorbidities, antipsychotic drugs, young adults, weight loss, body fat distribution, hippocampal volume, cognitive function, cardiovascular risk
- MeSH terms
- Adult, Blood Glucose, Diabetes Mellitus, Type 2, Double-Blind Method, Glucose, Humans, Hypoglycemic Agents, Insulin Resistance, Metformin, Schizophrenia
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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