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Completed

NCT Number: NCT02466087

Role of Magnesium Supplementation in the Treatment of Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Vermont

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mg Cl

Drug

Four supplements a day for 6 weeks.

Primary outcomes

  1. Patient Health Questionnaire-9

    Time frame: 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 outcomes

  1. Generalized Anxiety Disorder 7 Item Questionnaire

    Time frame: 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.

  2. Change in Headaches While Taking Supplements

    Time frame: 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)

    • Mild
    • Moderate
    • Severe (worse)

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2015
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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