BridgeMD
New treatment option for Depression
Official title Metformin as Adjunct Therapy in Depression-Obesity Comorbidity: Clinical and Genetic Evaluation
ClinicalTrials.gov ID: NCT07654179
What this study is testing
What is Metformin?
Metformin is an investigational medicine, being studied as a potential treatment for depression.
Also referred to as Trade names: Glucophage, Neodipar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults. Healthy volunteers may be eligible.
You may be able to join if
- Group I: Normal Controls Group II: Depression Group III: Obesity Group IV and V:
- Age ≥ 18 years
- Both males and females
- Recurrent depressive disorder (6A71) according to ICD-11,
- Asian cut off: Obese and overweight (BMI \< 23)
You likely can't join if
- Groups I-III: Negative Controls (Normal: no depression and Obesity for SNP comparison only)
- Age less than 18
- Dementia/ Mentally impaired who can not fill self report performas for inclusion criteria Group IV: Positive Control (RCT patients)
- Patients with comorbid conditions (HTN, CKD) if taking any drug for that condition.
- The patient is not an employee of the investigator study site, or a family member of the employees or the investigator, or otherwise dependent on the...
- The patient did not participate in other treatment trials during the 6 months before and at the time of this trial. The patient does not have a...
See the full eligibility criteria
- Group I: Normal Controls Group II: Depression Group III: Obesity Group IV and V:
- Age ≥ 18 years
- Both males and females
- Recurrent depressive disorder (6A71) according to ICD-11,
- Asian cut off: Obese and overweight (BMI \< 23)
- BDI score ≥ 13 or PHQ score ≥ 4
- Either medication-naïve or medication-free for at least 2 weeks before enrollment, or the patient did not take antidepressants during the last 7 days before study entry (discontinuation of effective medication to enable...
- In case of non-psychotropic medication: The patient received stable pharmacological medication for at least 14 days before study entry (any changes in medication dose or frequency of therapy must be answered with no)
- Groups I-III: Negative Controls (Normal: no depression and Obesity for SNP comparison only)
- Age less than 18
- Dementia/ Mentally impaired who can not fill self report performas for inclusion criteria Group IV: Positive Control (RCT patients)
- Patients with comorbid conditions (HTN, CKD) if taking any drug for that condition.
- The patient is not an employee of the investigator study site, or a family member of the employees or the investigator, or otherwise dependent on the sponsor, the investigator, or the investigator study site.
- The patient did not participate in other treatment trials during the 6 months before and at the time of this trial. The patient does not have a history of non-response to antidepressants included in the study.
- The patient has not given birth within the 6 months before study entry and is not breastfeeding
- The patient did not receive treatment with ketamine, irreversible MAO inhibitor (e.g. tranylcypromine), electroconvulsive therapy (ECT) or other stimulatory treatments in the index episode.
- The patient is not diagnosed with dementia and does not have moderate or severe impairment of general cognitive function according to clinical impression.
- The patient does not meet the criteria for alcohol use disorder (DSM-5: 303.90; ICD-10: F10.20) or substance use disorder (DSM-5: 304; ICD-10: F11.20 - F19.20) in DSM-5, and a urine/serum drug screening is negative...
- The patient does not have:
- A known allergy or contraindication against antidepressants included in the study
- History of suicidal tendencies
- Uncontrolled hepatic disorder, renal or cardiovascular disease
- Untreated hypothyroidism
- History of myocardial infarction or stroke
- Symptomatic peripheral arterial disease
- Monogenic familial hypercholesterolemia
The study team makes the final eligibility decision.
Where it's taking place
- Rawalpindi, Punjab Province, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rawalpindi, Punjab Province, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.