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

MDD Clinical Trial

Official title:

Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients: A Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880460
• Other study ID #: BSMMU/2021/257
• Status: Completed
• Phase: Phase 2
• Start date: March 18, 2021
• Est. completion date: November 21, 2021

Study information

• Verified date: November 2021
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, double-blind, placebo-controlled trial was conducted to assess the effect of magnesium glycinate on symptoms of moderate to severe depression in 90 patients. Patients were assessed at baseline, end of the 4 weeks, and end of the 8 weeks of treatment. Patients were randomized to receive either 200 mg elemental magnesium or 200 mg placebo tablet twice daily for 8 weeks. The primary outcome measure was depression severity score assessment using Depression Anxiety Stress Scale 21 items Bangla Version (DASS-21 BV) and the secondary outcome measure was serum magnesium level estimation and side effects assessment using a preformed checklist.

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 is 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 30% to 50% of patients do not respond to initial antidepressant medication, and 15% of them continue to suffer from symptoms despite the completion of multiple antidepressants and more aggressive treatment regimens, in addition to facing untoward adverse drug reactions with increasing dose. Recent trials attempted to assess the effect of magnesium in reducing depressive symptoms in MDD patients. This study evaluates whether there was any role of magnesium in reducing depressive symptoms between those who did and did not receive magnesium in 8 weeks period. Patients attending the Outpatient Department of Psychiatry, BSMMU, and diagnosed with MDD were evaluated using the DASS-21 BV for assessment of severity. Those patients who were experiencing moderate to severe symptoms (scores of 14-27) were enrolled according to inclusion and exclusion criteria. Total enrolled 90 MDD patients who have received either 200 mg elemental magnesium twice daily in the form of magnesium glycinate tablet or 200 mg placebo tablet twice daily for 8 weeks. A baseline depression severity score assessment was done using DASS-21 items and again repeated at the end of the 4 weeks and 8 weeks of treatment. Initially, baseline serum magnesium level (mg/dL) was measured and repeated again at the end of the 8 weeks of treatment. DASS-21 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, and each item is rated from 0 to 3. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest, anhedonia, and inertia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 21, 2021
• Est. primary completion date: November 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed 18 years or older MDD patients of both gender according to DSM-5 at the Outpatient Department of Psychiatry, BSMMU

• Moderate to severe MDD according to DASS-21 (scores of 14-27)

• Patients prescribed only SSRIs

Exclusion Criteria:

• Patients having any other psychiatric disease, kidney disease, or gastrointestinal disease

• Taking dietary supplements in the last two months

• Taking fluoroquinolones, aminoglycosides, tetracyclines, calcium channel blockers, bisphosphonates, and skeletal muscle relaxants

• Pregnancy and lactation

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• MDD

Intervention

Dietary Supplement:
• Magnesium Glycinate tablet 200mg
Magnesium glycinate tablet 200mg twice daily orally for 8 weeks along with SSRIs
• Placebo tablet 200mg
Placebo tablet 200mg twice daily orally for 8 weeks along with SSRIs

Locations

Country	Name	City	State
Bangladesh	Basic Science and Paraclinical Science of BSMMU	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression severity score assessment	Assessed the severity score of depressive symptoms using DASS-21 at baseline, end of the 4 weeks, and end of the 8 weeks treatment.; Compared the score between before and after treatment. Compared the score between two arms. DASS21 score range from 0-28+ with the following scores: 0-9 Normal, 10-13 Mild, 14-20 Moderate, 21-27 Severe, 28+ Extremely severe.	8 weeks
Secondary	Biochemical assessment	Serum magnesium level (mg/dL) was measured at baseline and end of the 8 weeks treatment.; Compared the serum magnesium level (mg/dL) between before and after treatment. Compare the serum magnesium level (mg/dL) between two arms.	8 weeks
Secondary	Side effects assessment	Participants were asked about the side effects using a preformed checklist. And compare the effects between two arms.	8 weeks