Combination Therapy of Different Antidepressants With Dietary Supplements
- Conditions
- Depression
- Interventions
- Dietary Supplement: Vitamin B12Dietary Supplement: L-methylfolateDietary Supplement: magnesium
- Registration Number
- NCT05931965
- Lead Sponsor
- Riphah International University
- Brief Summary
The aim of this clinical trial is to compare the effect of antidepressants in combination with different dietary supplements in patients with depression. Our main objective is to compare the efficacy of antidepressants in combination with either L-methyl folate, Vit B12, or magnesium) in patients with depressive disorders. The levels of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) at base level and during follow-up.
- Detailed Description
This is an open-label study assessing the comparative efficacy of antidepressants in combination therapy of either L-methylfolate, mecobalamin, or magnesium in patients with Depressive Disorder. The plan is to enroll 84 patients with depression based on Patient Health Questionnaire (PHQ-9) score of 9 and above, which is a valid and reliable Structured Clinical Interview. The investigators will collect data from the enrolled patient populations. The participants will be able to receive their results, on request, upon completion of the study. The investigators hypothesize that depressive symptoms can be improved by the addition of above mentioned nutritional supplementations with antidepressant medication.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Patients with Depressive Disorder having PHQ-9 Score 9 and above
- Age 12 and above
- Patients having low/marginal and low normal levels for arms 2 and 3 of respective supplements
- Patients having low/normal serum magnesium for arm 4
- Patients having psychiatric diagnosis other than Depressive Disorder according to the International Classification of Diseases 11th Revision (ICD-11)
- History of kidney disease, myasthenia gravis
- Mentally handicapped or terminally ill patients
- Age less than 12 years
- Patients already taking multiple nutritional supplements
- Patients on polypharmacy with potential interactions with antidepressants and supplements in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antidepressant and injectable mecobalamin Vitamin B12 Participants receive a combination of antidepressant and mecobalamin 500µg intramuscularly stat on alternate days (6 total injections) Antidepressant and L-methylfolate L-methylfolate Participants receive a combination of antidepressant and L-methylfolate 400µg twice daily orally for 4 weeks Antidepressant and Magnesium magnesium Participants receive a combination of antidepressant and magnesium glycinate 400mg (Elemental: ≈120mg) twice daily orally for 4 weeks
- Primary Outcome Measures
Name Time Method Patient Health Questionnaire (PHQ-9) Baseline and 4 weeks The 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.
- Secondary Outcome Measures
Name Time Method Depressive symptoms remission Baseline, 2 weeks, 4 weeks Remission rate of Major Depression in the two groups over the course of treatment, defining remission as a score ≤ 4 on the PHQ-9 scale.
Patient Health Questionnaire (PHQ-9) Baseline, 2-weeks and 4-weeks The change in the total PHQ-9 score between baseline, and the intermediate 2-weeks, and 4-weeks follow-up is the secondary outcome measures. 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.
Side-effects Baseline, 2-weeks, and 4-weeks follow up A self-assessment questionnaire for undesirable effects in psychopharmacological treatment, developed by the Department of Psychiatry, Riphah International University, Pakistan. This is to investigate the presence or absence of 4 symptoms (diarrhea, drowsiness, insomnia, and rash), and their relationship with the treatment.
Trial Locations
- Locations (1)
Pakistan Railway Hospital, IIMC-T, Riphah International University
🇵🇰Rawalpindi, Punjab, Pakistan