Role of Magnesium Supplementation in the Treatment of Depression
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|ClinicalTrials.gov Identifier: NCT02466087|
Recruitment Status : Unknown
Verified May 2016 by Emily Tarleton, University of Vermont.
Recruitment status was: Active, not recruiting
First Posted : June 9, 2015
Last Update Posted : May 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Magnesium chloride||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Magnesium Supplementation in the Treatment of Depression|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2018|
|Experimental: Mg Cl||
Drug: Magnesium chloride
Four supplements a day for 6 weeks.
|No Intervention: Control|
- Patient Health Questionnaire-9 [ Time Frame: Baseline and weeks 2, 4, 6, 8, 12 ]
- 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 ]Documentation of side effects (i.e. nausea, diarrhea) and severity (i.e. frequency, duration)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466087
|United States, Vermont|
|University of Vermont|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Emily Tarleton, MS, RD||University of Vermont|