RecruitingPhase 4ACTRN12613000856718

Metformin for Mind and Metabolism

Metformin for Mind and Metabolism: The effect of metformin 2000mg/day on mood and cognition in adults with treatment resistant depression and abdominal obesity: a pilot randomized placebo controlled trial over 12 weeks.

Sponsor

The Alfred Hospital

Enrollment

30 participants

Start Date

Jun 16, 2014

Study Type

Interventional

Conditions

Depression Abdominal Obesity

Summary

Metformin is a medication originally derived from French Lilac which has been used to treat diabetes for over 50 years. The aim of this study is to see whether metformin can improve mood and memory in people who have depression and obesity. We will recruit 30 adults who feel depressed despite currently taking an antidepressant medication and who also have a large waist measurement (more than 88cm for women and 102cm for men). The study will last for 12 weeks. Participants will be randomized to either metformin 1000mg twice per day with food or placebo. At the beginning and the end of the study mood will be rated by self-report and by the doctor’s impression. Memory will be measured using a series of computer based tests, similar to playing simple computer games. The hope is that metformin will help obese adults with depression by reducing levels of the hormone insulin as well as markers of inflammation, within the brain, thereby improving mood.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a diabetes medication called metformin can improve mood and memory in people who are both depressed and obese. Metformin has been used to treat type 2 diabetes for over 50 years, but researchers think it might also help the brain by lowering insulin levels and reducing inflammation. Participants will take either metformin or a placebo (sugar pill) for 12 weeks, and their mood and thinking skills will be measured at the start and end of the study. You may be eligible if: - You are between 18 and 65 years old - You are still having symptoms of depression despite taking an antidepressant for at least 8 weeks - You have a large waist measurement (over 88 cm for women, over 102 cm for men) - You are male or female You may NOT be eligible if: - You have kidney disease (eGFR below 60) - You are at risk of suicide - You have a psychotic disorder - You have diabetes - You are allergic to metformin or its ingredients Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Metformin 2 x 500mg oral tablets twice daily for 12 weeks (total daily dose 2000mg). Adherence will be monitored by counting drug returns on a monthly basis.