Role of Magnesium Supplementation in the Treatment of Depression

Phase 2

Completed

• Conditions: Depression
• Interventions: Drug: Mg Cl

• Registration Number: NCT02466087
• Lead Sponsor: University of Vermont

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-09
• Primary Completion: 2016-05
• Study Completion: 2016-12
• Results First Submitted: 2017-06-29
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Results First Posted: 2019-05-08
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mg Cl	Mg Cl	500mg Mg Cl per day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9	12 weeks	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

Name	Time	Method
Generalized Anxiety Disorder 7 Item Questionnaire	12 weeks	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	12 weeks	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); 1. Mild; 2. Moderate; 3. Severe (worse)

Trial Locations

Locations (1)

University of Vermont; 🇺🇸 Burlington, Vermont, United States