Combination Therapy of Different Antidepressants With Dietary Supplements

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

The aim of this clinical trial is to compare the effect of antidepressants in combination with different dietary supplements in patients with depression.

The levels of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) at base level and during follow-up.

It had four arms (groups): Antidepressant (no intervention), Antidepressant and L-methylfolate (experimental), Antidepressant and injectable mecobalamin (experimental) and Antidepressant and Magnesium (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

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.

Who Took Part

The registry lists 88 actual participants took part.

It was open to people of any sex aged from 12 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: history of kidney disease, myasthenia gravis; mentally handicapped or terminally ill patients; age less than 12 years.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

It started in 2022-10-05 with completion listed for 2023-07-30.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Patient Health Questionnaire (PHQ-9) (time frame: Baseline and 4 weeks).

It also tracked 3 secondary outcomes, for example Patient Health Questionnaire (PHQ-9), Side-effects and Depressive symptoms remission.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cyanocobalamin (Vitamin B12) in 88 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.