Clinical trial NCT06707012: Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
Official title: Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Depression
Keywords: Depression
oxidative stress
antidepressants
obesity
Lead sponsor: Fazaia Ruth Pfau Medical College
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Design This is a comparative clinical study with randomized groups. Participants will be allocated to either the metformin group or the placebo group in conjunction with standard antidepressant therapy. Randomization will be achieved using computer generated numbers in 1:1 ratio.

Metformin Group: Starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines.

Placebo Group: Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression

Setting:

At psychiatric Out Patient Department of Fazaia Ruth Pfau Medical College and Hospital Karachi Pakistan

Study Duration:

18 months
Primary purpose: TREATMENT

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.

Detailed description: This is a comparative clinical study with randomized groups. Participants will be allocated to either the metformin group or the placebo group in conjunction with standard antidepressant therapy. Randomization will be achieved using computer generated numbers in 1:1 ratio.

Metformin Group: Starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines.

Placebo Group: Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression.

Study will take place at psychiatric Out Patient Department of Fazaia Ruth Pfau Medical College and Hospital Karachi Pakistan

Investigators will recruit participants from the psychiatric outpatient department of PAF Hospital diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition for at least 2 weeks and having obesity. depression is assessed with help of Hamilton Depression Scale (HAM-D). Participants whose score is above 8 and will meet the inclusion criteria will be added in study.

Informed consent:

Participants who meets the criteria will be asked for written informed consent form and explain in detail about the study

Base Line Data Collection After taking informed consent, detailed history, physical examination, HbA1c and serum creatinine will be measured. Participants whose HbA1c results is below 5.7% and creatinine clearance is above 30% will be selected in the study. Investigators will assess HbA1c, serum creatinine levels at every 12 weeks' interval. Serum levels of antioxidant enzymes (superoxide dismutase, catalase, glutathione peroxidase) will measured in participants by using biochemical assays at baseline and at the end of the study.

Follow up visits Participants will be followed up six times throughout the study duration. 1st follow up visit will occur at 4th week to evaluate the response to treatment by using Hamilton depression rating scale for depression, as according to Maudsley guidelines initial response to treatment should be assessed within 4 weeks. Next follow ups will take place at every 6th week till 36 weeks to assess improvement in depression and changes in BMI.

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.

Primary outcomes:
measure: Decrease scoring of Hamilton depression rating scale
timeFrame: 18 months
Secondary outcomes:
measure: elevation in oxidative enzymes level (superoxide dismutase,catalase,glutathione peroxidase
timeFrame: 18 months
Other outcomes:
measure: change in Basal Metabolic Rate
timeFrame: 18 months
Locations:
city: Karachi
country: Pakistan
facility: Fazaia Rurh Pfau Medical College
state: Sindh
city: Karachi
country: Pakistan
facility: Fazaia Ruth Pfau Medical College
state: Sindh
Study officials:
affiliation: Fazaia Ruth Pfau Medical College
name: sadia khan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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