The Hearts and Minds clinical trial is aiming to determine whether metformin or atorvastatin help to reduce symptoms of major depression and improve quality of life.
About this study
We are inviting adults with depression to take part in this novel research trial investigating metformin or atorvastatin as treatments for depression.
Metformin is a medication to help treat diabetes, and atorvastatin is a blood pressure medication. There is a 1 in 3 (33%) chance that participants will receive either metformin, atorvastatin, or placebo (a substance that has no therapeutic effect).
During the trial, participants will take three medication tablets a day for 16 weeks.
Anticipated enrolment close date: December 2026
Study duration
First, participants will attend an eligibility screening visit. Then, the treatment phase will last for 16 weeks, with a follow-up phone call 6 months after the last treatment.
The trial will be recruiting participants for approximately 3 years.
Who can take part
This trial might be right for you if you:
- Are aged 18 years and over
- Currently have major depressive disorder
- Do not have a bipolar, psychotic or substance use disorder
Please note that other eligibility criteria also apply.
What's involved
- Attending seven visits at RMH, plus a follow-up telephone call six months after finishing the trial medication
- Taking three medication tablets a day for 16 weeks
- Completing interviews and questionnaires
- Safety blood tests
Trial registration
Visit the Australian and New Zealand Clinical Trials Registry (ANZCTR) website to register for this trial.