NCT06707012 Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
| NCT ID | NCT06707012 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fazaia Ruth Pfau Medical College |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2025-10-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * • Age \>18 to \<45 years * Gender: Both genders (Male and Female) * BMI \>25 * Diagnosis: Newly diagnose cases of depression (mild to severe) * HBA1C: Less than 5.7% (non-diabetic range) Exclusion Criteria: * Existing diabetes * Acute illnesses like acute kidney injury, recent history of myocardial infarction, acute liver injury * Intellectual disabilities or inability to understand due to any reason * Presence of Psychiatric disorders other than depression * Chronic kidney disease (eGFR \< 45 mL/min/1.73 m²). * Use of any psychotropic medication within the past 6 months.
Contact & Investigator
sadia khan, MBBS
PRINCIPAL INVESTIGATOR
Fazaia Ruth Pfau Medical College
Frequently Asked Questions
Who can join the NCT06707012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06707012 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06707012 currently recruiting?
Yes, NCT06707012 is actively recruiting participants. Contact the research team at sadiakhansk30@gmail.com for enrollment information.
Where is the NCT06707012 trial being conducted?
This trial is being conducted at Karachi, Pakistan, Karachi, Pakistan.
Who is sponsoring the NCT06707012 clinical trial?
NCT06707012 is sponsored by Fazaia Ruth Pfau Medical College. The principal investigator is sadia khan, MBBS at Fazaia Ruth Pfau Medical College. The trial plans to enroll 140 participants.
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