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

NCT06707012 Phase 4 RECRUITING

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.

Details

Lead sponsor	Fazaia Ruth Pfau Medical College
Phase	Phase 4
Status	RECRUITING
Enrolment	140
Start date	2025-10-01
Completion	2026-12

Conditions

• Depression

Interventions

• Metformin Hydrochloride

Primary outcomes

• Decrease scoring of Hamilton depression rating scale — 18 months
  Primary outcome measure will be the improvement in depressive symptoms, indicating by a change in Hamilton Depression Rating Scale (HAM-D) scores. Decrease in the score will be considered as indicator of improvement in depression. 0-7: Normal (no depression) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23 and above: Very severe depression Investigators will compare the change in both groups.

Countries

Pakistan