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

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

Inclusion Criteria3

  • adults aged 18-65
  • ongoing symptoms of depression (MADRS>10) despite at least 8 weeks on a stable dose of an antidepressant
  • adbominal obesity (waist circumference >88cm for women or 102cm for men)

Exclusion Criteria5

  • renal impairment (eGFR<60)
  • suicidal
  • psychotic disorders
  • diabetes mellitus
  • allergy to metformin, lactose or other component of metformin or placebo formulations

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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.

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.


Locations(1)

VIC, Australia

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