Overview

This trial is active, not recruiting.

Condition depression
Treatment magnesium chloride
Phase phase 2/phase 3
Sponsor University of Vermont
Start date May 2015
End date December 2017
Trial size 100 participants
Trial identifier NCT02466087, M15-337

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
magnesium chloride
Four supplements a day for 6 weeks.
(No Intervention)

Primary Outcomes

Measure
Patient Health Questionnaire-9
time frame: Baseline and weeks 2, 4, 6, 8, 12

Secondary Outcomes

Measure
Generalized Anxiety Disorder 7 Item Questionnaire
time frame: Baseline and weeks 2, 4, 6, 8, 12
Number and severity of side effects
time frame: Baseline and weeks 2, 4, 6, 8, 12

Eligibility Criteria

Male or female participants at least 18 years old.

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 MVI or magnesium supplement

Additional Information

Official title Role of Magnesium Supplementation in the Treatment of Depression
Principal investigator Emily Tarleton, MS, RD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Vermont.