Metformin / Overweight Or Obesity / Depression · Interventional Study

Metformin as Adjunct Therapy in Depression-obesity Comorbidity: Clinical and Genetic Evaluation

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned interventional study (NCT07654179) currently recruiting 200 participants to evaluate metformin as adjunct to antidepressant therapy in depression-obesity comorbidity, with genetic stratification by NEGR1/RPL31P12 polymorphisms. No results are posted in this registry record; the study design, statistical power, and control allocation are not specified, making premature judgment impossible.

What was studied

Interventional, Randomized, Parallel, Open label, Treatment purpose. Depression, Depressive Disorder, Overweight or Obesity, Depressive Symptoms; accepts healthy volunteers. Intervention: Adjunctive Metformin Therapy. Compared with: Antidepressant Monotherapy — Active Comparator. n = 200. 2 sites: Pakistan.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing a planned interventional study with no results posted; enrollment is ongoing and no outcome data are available for evaluation.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in Severity of the depression (assessed at 1 month); Change in BMI (assessed at 3 months)

DesignInterventional, Randomized, Parallel, Open label, Treatment purpose

PopulationDepression, Depressive Disorder, Overweight or Obesity, Depressive Symptoms; accepts healthy volunteers

Sample size200

InterventionAdjunctive Metformin Therapy

ComparatorAntidepressant Monotherapy — Active Comparator

Setting2 sites: Pakistan

Reported figures

Quoted from the source exactly as published.

Estimated enrollment200

Primary outcome measure 1Change in Severity of the depression, 1 month

Primary outcome measure 2Change in BMI, 3 months

Caveats

This is a registry record only; no results are posted or available for analysis.
Study phase not designated; randomization and blinding status not stated.
Comparator arm (antidepressant monotherapy) mentioned in brief summary but control design not formally specified in registry record.
Genetic stratification strategy (NEGR1/RPL31P12) described but power to detect gene-treatment interactions not reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Interventional study design stated; phase designation absent; no control arm clearly described.

Directness

insufficient

Registry record does not report results; directness cannot be assessed.

Consistency

insufficient

No results reported; consistency with other evidence cannot be evaluated.

Risk of bias

insufficient

Study design details insufficient to assess bias; blinding, randomization not stated.

Sample adequacy

moderate

Estimated enrollment 200 participants; adequate for exploratory design if completed.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07654179). This is a study registration, not published results. Lead sponsor: Riphah International University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Depression, Depressive Disorder, Overweight or Obesity, Depressive Symptoms. Interventions: DRUG: Metformin; DRUG: Antidepressant Therapy. Primary outcome measures: Change in Severity of the depression , 1 month; Change in BMI , 3 months. Brief summary: The patients with depression and obesity will receive add-on metformin with antidepressant therapy, which may result in greater improvement in depressive symptoms and BMI reduction compared to antidepressant monotherapy. NEGR1/RPL31P12 gene polymorphisms may influence the comparative efficacy of antidepressant monotherapy versus combination therapy (antidepressant + metformin) in Pakistani patients. Patients with certain variants may respond better or worse to antidepressants and may have different weight outcomes.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

MetforminOverweight Or ObesityNCT07654179DepressionDepressive DisorderRiphah International UniversityAntidepressant Therapy