Role of Magnesium Supplementation in the Treatment of Depression

Depression Clinical Trial

Official title:

Role of Magnesium Supplementation in the Treatment of Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466087
• Other study ID #: M15-337
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2019
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Mg Cl
Four supplements a day for 6 weeks.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 weeks
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.	12 weeks
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); Mild; Moderate; Severe (worse)	12 weeks