Phase 3
N=126
Role of Magnesium Supplementation in the Treatment of Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02466087 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Patient Health Questionnaire-9 — -4.28; -0.09 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mg Cl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Health Questionnaire-9 |
-4.28; -0.09 | — |
| SECONDARY Generalized Anxiety Disorder 7 Item Questionnaire |
-3.88; 0.80 | — |
| SECONDARY Change in Headaches While Taking Supplements |
-0.14; -0.14 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02466087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.