Combination Therapy of Different Antidepressants With Dietary Supplements

Riphah International University

Status

Completed

Conditions

Depression

Treatments

Dietary Supplement: magnesium

Dietary Supplement: Vitamin B12

Dietary Supplement: L-methylfolate

Study type

Interventional

Funder types

Other

Identifiers

NCT05931965

Riphah/IIMC/IRC/22/2069

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

88 participants in 4 patient groups

Antidepressant

No Intervention group

Description:

Participants receive either escitalopram 10-20mg, sertraline 50-100mg, fluoxetine 20-40mg, duloxetine 30-60mg, mirtazapine 15-30mg, venlafaxine 75-150mg, trazodone 50-100mg, amitriptyline 25-75mg, or clomipramine 25-75mg orally daily for 4 weeks.

Antidepressant and L-methylfolate

Experimental group

Description:

Participants receive a combination of antidepressant and L-methylfolate 400µg twice daily orally for 4 weeks

Treatment:

Dietary Supplement: L-methylfolate

Antidepressant and injectable mecobalamin

Experimental group

Description:

Participants receive a combination of antidepressant and mecobalamin 500µg intramuscularly stat on alternate days (6 total injections)

Treatment:

Dietary Supplement: Vitamin B12