Role of Magnesium Supplementation in the Treatment of Depression

Study Overview
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Brief Summary
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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.

Official Title
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Role of Magnesium Supplementation in the Treatment of Depression

Conditions
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Depression

Intervention / Treatment
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* Drug: Mg Cl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mg Cl<br>500mg Mg Cl per day for 6 weeks | Drug: Mg Cl<br>* Four supplements a day for 6 weeks.<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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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 |