Role of Magnesium Supplementation in the Treatment of Depression

The objective of this project is to test the hypothesis that magnesium supplementation will decrease depressive symptoms in adults.

This study takes place over 12 consecutive weeks. While the investigators will follow the volunteers for the full 12 weeks volunteers will only take magnesium supplements for 6 consecutive weeks. Volunteers will be randomly assigned to start the supplement at week 1 or week 7. Volunteers will take two supplement two times a day for a total of 248 mg elemental magnesium daily in the form of magnesium chloride. This amount of magnesium is less than the tolerable upper limit of 350 mg per day. The supplements will be provided. Volunteers will be asked to maintain their normal diet for the 12 weeks of the study.

The primary outcome measure is the PHQ-9 questionnaire, a validated measure of depression. Secondary measures include the GAD-7 for Anxiety and side effects.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: Mg Cl

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adults at least 18 years of age
• A Patient Health Questionnaire-9 (PHQ-9) score of greater or equal to 5 but less than 20
• People who are currently being treated for depression are still eligible to participate but their treatment must be stable (no changes in medication dose or brand and/or no changes in therapy regimen for at least 2 months).

Exclusion Criteria:

• Active delirium or dementia
• Medicinal treatment for bipolar disorder, personality disorder or schizophrenia,
• Glomerular Filtration Rate of less than 60
• Irritable Bowel Disease
• Inflammatory Bowel Disease
• GERD
• Gastritis
• Pregnant as reported by potential volunteer
• Myasthenia Gravis
• Planned elective surgery

• Currently taking

  • Long Term Antibiotics
  • Fluoroquinolone
  • Trientine or Penicillamine
  • Long Term Antivirals
  • Digoxin
  • Bisphosphonates
  • Eltrombopag
  • Opiods
  • Calcium Channel Blockers
  • Deferiprone
  • Doxercalciferol
• Unable or unwilling to stop taking a magnesium supplement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: Mg Cl; 500mg Mg Cl per day for 6 weeks	Drug: Mg Cl; Four supplements a day for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9	Change in score from week 1 to week 6 and week 7 to week 12 (difference in differences) The Patient Health Questionnaire-9 Item is a validated questionnaire with high sensitivity and specificity for the diagnosis of depression. The PHQ-9 score can range from 0 to 27, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-19 Moderate to Severe; 20-27 Severe.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder 7 Item Questionnaire	Change in score from week 1 to week 6 and week 7 to 12 (difference in differences) GAD-7 score has been shown to be a valid indication of anxiety symptoms. The GAD-7 score can range from 0 to 21, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-21 Severe.	12 weeks
Change in Headaches While Taking Supplements	Change in headaches compared to normal during the 6 weeks on supplements. Change was calculated from 2 time points-start of supplements and end of supplements. Change was recorded as 0, None (same); Mild; Moderate; Severe (worse)	12 weeks

Collaborators and Investigators

• Sponsor: University of Vermont
• Investigators: Principal Investigator: Emily Tarleton, MS, RD, University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: M15-337