Recruiting nowNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
AgeNot listed to Not listed
SexAll
Healthy volunteersAccepted
ConditionDepression, Depressive Disorder, Overweight or Obesity, Depressive Symptoms
Full registry criteria
INCLUSION 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 study participation is prohibited) * 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) EXCLUSION CRITERIA 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 interventional 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 (except for benzodiazepines and opiates). * 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 * DM * Untreated hypothyroidism * History of myocardial infarction or stroke * Symptomatic peripheral arterial disease * Monogenic familial hypercholesterolemia
Primary outcomes
Change in Severity of the depression1 monthThe change in the total PHQ-9 score between baseline and 4-weeks follow-up is the primary outcome measure. This measure is a patient-rated inventory of depressive symptoms. All items are scored on scales ranging from 0-3 and the sum of the scores provides the total score for the measure. On this scale, higher scores indicate poorer outcomes. Scores 9-19 and 20-27 are considered moderate and severe depression respectively.
Change in BMI3 monthsChange in Body Mass Index (BMI): BMI will be measured at baseline and study completion and calculated as weight in kilograms divided by height in meters squared (kg/m²). The outcome will be assessed as the change in BMI from baseline. Asian BMI Classification: Underweight: \< 18.5 kg/m² Normal weight: 18.5-22.9 kg/m² Overweight: 23.0-24.9 kg/m² Obesity Class I: 25.0-29.9 kg/m² Obesity Class II: ≥ 30.0 kg/m² BMI reduction \< 1 kg/m²: Minimal change BMI reduction ≥ 1 kg/m²: Clinically meaningful improvement Weight loss ≥ 5% of baseline body weight: Clinically significant weight reduction associated with metabolic health benefits. A decrease in BMI from baseline and/or movement to a lower BMI category will be considered indicative of improvement in obesity-related outcomes.
