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NCT Number: NCT05931965

Combination Therapy of Different Antidepressants With Dietary Supplements

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway Hospital, IIMC-T, Riphah International University

Rawalpindi, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-methylfolate

Dietary Supplement

Participants receive L-methylfolate 400µg orally twice daily for 4 weeks

Other names: 5-methyl-terahydrofolate

Vitamin B12

Dietary Supplement

Participants receive mecobalamin 500µg intramuscularly stat on alternate days (6 total injections)

Other names: mecobalamin

magnesium

Dietary Supplement

Participants receive magnesium glycinate 400mg twice daily orally for 4 weeks (elemental 120mg approx.)

Other names: Mg

Primary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 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 outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 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.

  2. Side-effects

    Time frame: 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.

  3. Depressive symptoms remission

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Efficacy of Antidepressants With L-methylfolate, B12, and Magnesium in Depressive Disorders

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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