DepressionPhase 2/3NCT02466087

Role of Magnesium Supplementation in the Treatment of Depression

A Phase 2/3 study testing Mg Cl in people with Depression, run by University of Vermont at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression
What is being tested?: Mg Cl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteUnited States
Study dates: May 2015to Dec 2016
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Show all 23Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

University of Vermont
Burlington, Vermont, 05401

Other trials in United States

About this study

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
Being tested: Mg Cl
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mg ClDrug
Four supplements a day for 6 weeks.

Study groups in NCT02466087
Study group	Role	What they receive
Mg Cl	Experimental	500mg Mg Cl per day for 6 weeks Receives: Drug: Mg Cl
Control	No intervention	No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Secondary outcomes (2)

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.
Measured: 12 weeks
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)
1. Mild
2. Moderate
3. Severe (worse)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Dec 2016

First posted9 Jun 2015 (estimated)
Study startMay 2015
Primary completionMay 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02466087
Sponsor's protocol ID: M15-337
Status last verified: Apr 2019
First submitted: 29 May 2015
Last updated: 8 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Magnesium Supplementation in the Treatment of Depression
ClinicalTrials.gov ID: NCT02466087
Acronym / sponsor ID: M15-337
Conditions: Depression
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: University of VermontUniversity, hospital or other
Study start: May 2015 (actual)
Primary completion: May 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 9 Jun 2015 (estimated)
Results: Posted 8 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this project is to test the hypothesis that magnesium supplementation will decrease depressive symptoms in adults.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mg Cl	Experimental	Drug: Mg Cl500mg Mg Cl per day for 6 weeks
Control	No intervention	–No intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mg ClFour supplements a day for 6 weeks.	Drug	Mg Cl

Primary outcome

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.

2 secondary outcomes

Generalized Anxiety Disorder 7 Item Questionnaire
Time frame: 12 weeks
Change in Headaches While Taking Supplements
Time frame: 12 weeks

Results and safety

Results posted to the registry on 8 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mg Cl (Weeks 1-6), Then no Intervention (Weeks 7-12)	62	55
No Intervention (Weeks 1-6), Then MgCl (Weeks 7-12)	64	57

Primary outcome: Patient Health Questionnaire-9

Time frame: 12 weeks. Mean (95% Confidence Interval). Unit: score on a scale

Measure	MgCl n = 112	Control n = 112
Value	-4.28 (-4.99 to -3.56)	-0.09 (-0.90 to 0.72)

MgCl vs Control: diiference in differences: 1.5, Regression, Linear

Population analysed: Number of participants with analyzable data.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mg Supplementation	0 of 62 (0%)	0 of 62 (0%)	0 of 62
Control	0 of 64 (0%)	0 of 64 (0%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emily Tarleton, MS, RD principal investigator

University of Vermont

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Mg Cl in people with Depression, run by University of Vermont at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire-9 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02466087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.