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

NCT04880460 | Completed Phase 2

• 1 other identifier: BSMMU/2021/257
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MDD

Keywords

MDD; Magnesium; DASS-21; Serum magnesium level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Biochemical assessment

  8 weeks

• Side effects assessment

  8 weeks

Study Arms (2)

Experimental

ACTIVE COMPARATOR

45 MDD patients were included in this arm who were received SSRIs and Magnesium tablets

Dietary Supplement: Magnesium Glycinate tablet 200mg

Control

PLACEBO COMPARATOR

45 MDD patients were included in this arm who were received SSRIs and placebo tablets

Dietary Supplement: Placebo tablet 200mg

Interventions

Magnesium Glycinate tablet 200mg DIETARY_SUPPLEMENT

Magnesium glycinate tablet 200mg twice daily orally for 8 weeks along with SSRIs

Experimental

Placebo tablet 200mg DIETARY_SUPPLEMENT

Placebo tablet 200mg twice daily orally for 8 weeks along with SSRIs

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Basic Science and Paraclinical Science of BSMMU

Dhaka, Bangladesh

Location

MeSH Terms

Interventions

magnesium diglycinate

Study Officials

• Prof. Md. Sayedur Rahman, MBBS, MPhil, FCPS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. The type of masking was double-blind masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 10, 2021
• Study Start: March 18, 2021
• Primary Completion: November 21, 2021
• Study Completion: November 21, 2021
• Last Updated: March 21, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)