Depression
Conditions
Keywords
Depression, magnesium, Vit B12, L-methylfolate
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.
Interventions
DIETARY_SUPPLEMENTL-methylfolate
Participants receive L-methylfolate 400µg orally twice daily for 4 weeks
DIETARY_SUPPLEMENTVitamin B12
Participants receive mecobalamin 500µg intramuscularly stat on alternate days (6 total injections)
DIETARY_SUPPLEMENTmagnesium
Participants receive magnesium glycinate 400mg twice daily orally for 4 weeks (elemental 120mg approx.)
Sponsors
Riphah International University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Pakistan
Outcome results
None listed