A Phase 2/3 interventional study of Mg Cl in Depression, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-08.
Sponsored by University of Vermont · Phase 2/3, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 126 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Currently taking
500mg Mg Cl per day for 6 weeks
Drug: Mg Cl
No intervention
Four supplements a day for 6 weeks.
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.
Time frame: 12 weeks
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.
Time frame: 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) 1. Mild 2. Moderate 3. Severe (worse)
Time frame: 12 weeks
| Milestone | Mg Cl (Weeks 1-6), Then no Intervention (Weeks 7-12) | No Intervention (Weeks 1-6), Then MgCl (Weeks 7-12) |
|---|---|---|
| Started | 62 | 64 |
| Completed | 55 | 57 |
| Not completed | 7 | 7 |
| Milestone | Mg Cl (Weeks 1-6), Then no Intervention (Weeks 7-12) | No Intervention (Weeks 1-6), Then MgCl (Weeks 7-12) |
|---|---|---|
| Started | 55 | 57 |
| Completed | 55 | 57 |
| Not completed | 0 | 0 |
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.
| score on a scale | MgCl | Control |
|---|---|---|
| Patient Health Questionnaire-9 | -4.28 (-4.99 to -3.56) | -0.09 (-0.90 to 0.72) |
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.
| scores on a scale | MgCl | Control |
|---|---|---|
| Generalized Anxiety Disorder 7 Item Questionnaire | -3.88 (-4.70 to -3.07) | 0.80 (0.02 to 1.59) |
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)
| score on a scale | MgCl | Control |
|---|---|---|
| Change in Headaches While Taking Supplements | -0.14 (-0.25 to -0.03) | -0.14 (-0.25 to -0.03) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mg Supplementation | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Control | 0/64 (0%) | 0/64 (0%) | 0/64 (0%) |
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Mean | 52.4 ± 12.9 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 78 |
| Male | 48 |
| Race (NIH/OMB)(Participants) | Entire Study Population |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 123 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Entire Study Population |
|---|---|
| United States | 126 |
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Vermont