Assess the Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients

  • STATUS
    Recruiting
  • participants needed
    90
  • sponsor
    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Updated on 9 December 2021

Summary

The proposed study is 8 weeks, randomized, double-blind, placebo-controlled trial to assess the effect of magnesium glycinate on symptoms of moderate and severe depression in 90 patients. Participants will be assessed at baseline, 4 weeks, and 8 weeks. Subjects will be randomized to receive either 400 mg elemental magnesium daily or 400 mg placebo tablet daily for 8 weeks. The primary outcome is the measure of the DASS21 questionnaire and the secondary measure includes serum magnesium level.

Description

Major depressive disorder (MDD), is a mood disorder affecting 300 million people worldwide with a prevalence of 6.7% in Bangladesh. Depression is the main contributor to suicidal deaths and globally ranked as the single largest contributor to non-fatal health loss. Various psychological, genetic, environmental, and biochemical factors are presumed to be involved in the causation of MDD. About 60-70% of individuals with MDD do not achieve complete remission from symptoms to conventional available anti-depressant medicines. Recent trials attempted to assess the effect of magnesium in reducing depressive symptoms in MDD patients. This study evaluates whether there is any role of magnesium in reducing depressive symptoms between those who did and did not receive magnesium in an 8 weeks period. This includes 90 major depressive patients who were recruited from psychiatry OPD of BSMMU. Participants will take either 400 mg elemental magnesium daily in the form of magnesium glycinate tablet or 400 mg placebo tablet daily for 8 weeks. Initially, baseline serum magnesium level will be measured and repeated again after 8 weeks of intervention. A baseline depression survey will be done by DASS21 items and also repeated at 4 weeks and 8 weeks. DASS21 is a validated set of three self-report scales to measure the state of depression, anxiety, and stress, where each of the three scales contains 7 items. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest, anhedonia, and inertia.

Details
Condition Major depression, major depressive disorders
Treatment Magnesium Glycinate tablet 200mg, Placebo tablet 200mg
Clinical Study IdentifierNCT04880460
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Last Modified on9 December 2021

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