Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients

Sponsor
Fazaia Ruth Pfau Medical College
Study ID
NCT06707012
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride — DRUG
    Participants will be divided in 2 groups 1 group will receive metformin and 2nd group will receive placebo

Study Details

To evaluate the efficacy of metformin as an adjunct therapy in improving depressive symptoms and metabolic markers in newly diagnosed obese depressed patients on standard antidepressant therapy. investigator will compare between Two groups 1\. metformin group 2 placebo group Primary outcome measure will be the improvement in depressive symptoms, indicating by a reduction in Hamilton Depression Rating Scale (HAM-D) scores. Secondary outcome measures will include the assessment of oxidative stress markers, specifically by measuring the increase in enzymatic activity of superoxide dismutase, catalase, and glutathione peroxidase Investigators hypothesize that the addition of metformin to standard antidepressant treatment will result in a significant reduction in symptoms of depression among newly diagnosed obese individuals.

Key Dates

Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    We will prescribe metformin with starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines.
  • Placebo Comparator: placebo group
    Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression

Primary Outcome Measure

Decrease scoring of Hamilton depression rating scale [ Time Frame: 18 months ]

Central Contacts

Related Studies