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Role of Magnesium Supplementation in the Treatment of Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mg Cl
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mg Cl

Control

Arm Description

500mg Mg Cl per day for 6 weeks

No intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)

Full Information

First Posted
May 29, 2015
Last Updated
April 15, 2019
Sponsor
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT02466087
Brief Title
Role of Magnesium Supplementation in the Treatment of Depression
Official Title
Role of Magnesium Supplementation in the Treatment of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mg Cl
Arm Type
Experimental
Arm Description
500mg Mg Cl per day for 6 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Mg Cl
Intervention Description
Four supplements a day for 6 weeks.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder 7 Item Questionnaire
Description
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.
Time Frame
12 weeks
Title
Change in Headaches While Taking Supplements
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Tarleton, MS, RD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Role of Magnesium Supplementation in the Treatment of Depression

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