Role of Magnesium Supplementation in the Treatment of Depression

NCT02466087 | Completed Phase 2 Results

• 1 other identifier: M15-337
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Generalized Anxiety Disorder 7 Item Questionnaire

  12 weeks

• Change in Headaches While Taking Supplements

  12 weeks

Study Arms (2)

Mg Cl

EXPERIMENTAL

500mg Mg Cl per day for 6 weeks

Drug: Mg Cl

Control

NO INTERVENTION

No intervention

Interventions

Mg Cl DRUG

Four supplements a day for 6 weeks.

Mg Cl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Emily Tarleton, MS, RD
• Organization: University of Vermont

emily.tarleton@uvm.edu

802-847-4730

Study Officials

• Emily Tarleton, MS, RD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bionutrition Research Manager

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 9, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 8, 2019
• Results First Posted: May 8, 2019

Record last verified: 2019-04

Locations

US (1)