Role of Magnesium Supplementation in the Treatment of Depression

University of Vermont

Status and phase: Completed; Phase 3; Phase 2

Conditions: Depression

Treatments: Drug: Mg Cl

Study type: Interventional

Funder types: Other

Identifiers

NCT02466087

M15-337

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Mg Cl

Experimental group

Description:

500mg Mg Cl per day for 6 weeks

Treatment:

Drug: Mg Cl

Control

No Intervention group

Description:

No intervention