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Effectiveness of metformin in reducing weight gain caused by antipsychotics

Metformin for treatment of atypical antipsychotic induced weight gain: a randomized double blind placebo controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2010/004
Enrollment
Unknown
Registered
2010-07-02
Start date
2010-07-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

The study drug is metformin. Intervention group will be given metformin and the control group a similar appearing placebo one tablet tds. Intervention group Metformin dose- commencing dose 250mg b.d.

Sponsors

Faculty of Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with schizophrenia or schizoaffective disorder according to ICD-10 research criteria 2.Age > 18 years 3.Treated with olanzapine, risperidone or clozapine 4. Gained more than 10% of the pre treatment body weight

Exclusion criteria

Exclusion criteria: 1. Those concurrently treated with other psychotropics known to cause weight gain, (lithium carbonate, carbamazepine, sodium valproate and antidepressants) 2. Patients too ill to consent 3. Patients previously diagnosed with diabetes 4. Pregnant patients 5. Patients with impaired renal functions before enrollment (Sample size calculation is based on an expected difference in weight of Body Weight Gain of between the 2 groups, a power of 80%, and a Type I error of 5%. Sample size required in each group=64)

Design outcomes

Primary

MeasureTime frame
change in total body weight [Baseline, 12 weeks and 24 weeks]

Secondary

MeasureTime frame
Body Mass Index (BMI), waist/hip ratio, fasting blood sugar, lipid profile [Baseline, 12 weeks and 24 weeks]

Countries

Sri Lanka

Contacts

Public ContactDr. Varuni de Silva

Senior Lecturer in Psychiatry

varunidesilva2@yahoo.co.uk2574011 2691581

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026