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Trial record 1 of 48 for:    "Depressive Disorder" [DISEASE] | ( Map: Vermont, United States )
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Role of Magnesium Supplementation in the Treatment of Depression

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ClinicalTrials.gov Identifier: NCT02466087
Recruitment Status : Unknown
Verified May 2016 by Emily Tarleton, University of Vermont.
Recruitment status was:  Active, not recruiting
First Posted : June 9, 2015
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Emily Tarleton, University of Vermont

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.


Condition or disease Intervention/treatment Phase
Depression Drug: Magnesium chloride Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Magnesium Supplementation in the Treatment of Depression
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mg Cl Drug: Magnesium chloride
Four supplements a day for 6 weeks.

No Intervention: Control



Primary Outcome Measures :
  1. Patient Health Questionnaire-9 [ Time Frame: Baseline and weeks 2, 4, 6, 8, 12 ]

Secondary Outcome Measures :
  1. Generalized Anxiety Disorder 7 Item Questionnaire [ Time Frame: Baseline and weeks 2, 4, 6, 8, 12 ]
  2. Number and severity of side effects [ Time Frame: Baseline and weeks 2, 4, 6, 8, 12 ]
    Documentation of side effects (i.e. nausea, diarrhea) and severity (i.e. frequency, duration)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 MVI or magnesium supplement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466087


Locations
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United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
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Principal Investigator: Emily Tarleton, MS, RD University of Vermont

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Responsible Party: Emily Tarleton, Bionutrition Research Manager, University of Vermont
ClinicalTrials.gov Identifier: NCT02466087     History of Changes
Other Study ID Numbers: M15-337
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders