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

• ClinicalTrials.gov Identifier: NCT04880460
• Recruitment Status: Completed
• First Posted: May 10, 2021
• Last Update Posted: March 21, 2022
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Information provided by (Responsible Party): Dr. Sarmin Sultana, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Tracking Information

• First Submitted Date: May 4, 2021
• First Posted Date: May 10, 2021
• Last Update Posted Date: March 21, 2022
• Actual Study Start Date: March 18, 2021
• Actual Primary Completion Date: November 21, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 6, 2022)

Depression severity score assessment [ Time Frame: 8 weeks ]

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.

Original Primary Outcome Measures (submitted: May 7, 2021)

Depression severity score assessment [ Time Frame: 8 weeks ]

Assess the severity score of depressive symptoms by DASS-21 (Depression Anxiety and Stress Scale) at baseline, after 4 weeks , and after 8 weeks. And compare the score between two group. 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.

Current Secondary Outcome Measures (submitted: March 6, 2022)

• Biochemical assessment [ Time Frame: 8 weeks ]
  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.
• Side effects assessment [ Time Frame: 8 weeks ]
  Participants were asked about the side effects using a preformed checklist. And compare the effects between two arms.

Original Secondary Outcome Measures (submitted: May 7, 2021)

Biochemical assessment [ Time Frame: 8 weeks ]

Serum magnesium level is assessed at baseline and after 8 weeks intervention. Compare the serum magnesium level between two group.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients
• Official Title: Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients: A Randomized, Double-Blind, Placebo-Controlled Trial
• 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Double (Participant, Investigator)
Masking Description:

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.

Primary Purpose: Treatment

• Condition: MDD

Intervention

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

Study Arms

• Active Comparator: Experimental
  45 MDD patients were included in this arm who were received SSRIs and Magnesium tablets
  Intervention: Dietary Supplement: Magnesium Glycinate tablet 200mg
• Placebo Comparator: Control
  45 MDD patients were included in this arm who were received SSRIs and placebo tablets
  Intervention: Dietary Supplement: Placebo tablet 200mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2021): 90
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 21, 2021
• Actual Primary Completion Date: November 21, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bangladesh

Administrative Information

• NCT Number: NCT04880460
• Other Study ID Numbers: BSMMU/2021/257
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr. Sarmin Sultana, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Original Responsible Party: Same as current
• Current Study Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Prof. Md. Sayedur Rahman, MBBS, MPhil, FCPS; Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

• PRS Account: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Verification Date: November 2021