Depression
Conditions
Brief 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.
Interventions
DRUGMg Cl
Four supplements a day for 6 weeks.
Sponsors
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder 7 Item Questionnaire | 12 weeks | 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. |
| Change in Headaches While Taking Supplements | 12 weeks | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive MgCl first and no intervention first | 126 |
| Total | 126 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 12.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 123 Participants |
| Region of Enrollment United States | 126 Participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 64 |
| other Total, other adverse events | 0 / 62 | 0 / 64 |
| serious Total, serious adverse events | 0 / 62 | 0 / 64 |
Outcome results
Primary
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
Population: Number of participants with analyzable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MgCl | Patient Health Questionnaire-9 | -4.28 score on a scale |
| Control | Patient Health Questionnaire-9 | -0.09 score on a scale |
Regression, Linear
Secondary
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
Population: headaches
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MgCl | Change in Headaches While Taking Supplements | -0.14 score on a scale |
| Control | Change in Headaches While Taking Supplements | -0.14 score on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MgCl | Generalized Anxiety Disorder 7 Item Questionnaire | -3.88 scores on a scale |
| Control | Generalized Anxiety Disorder 7 Item Questionnaire | 0.80 scores on a scale |