Trial Outcomes & Findings for Role of Magnesium Supplementation in the Treatment of Depression (NCT NCT02466087)

NCT ID: NCT02466087

Last Updated: 2019-05-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 126 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-05-08

Participant Flow

Participant milestones

Measure	Mg Cl (Weeks 1-6), Then no Intervention (Weeks 7-12) MgCl for weeks 1-6 and then no treatment for weeks 7-12	No Intervention (Weeks 1-6), Then MgCl (Weeks 7-12) No Treatment for weeks 1-6 and then MgCl for weeks 7-12
First Intervention: Weeks 1-6 STARTED	62	64
First Intervention: Weeks 1-6 COMPLETED	55	57
First Intervention: Weeks 1-6 NOT COMPLETED	7	7
Second Intervention: Weeks 7-12 STARTED	55	57
Second Intervention: Weeks 7-12 COMPLETED	55	57
Second Intervention: Weeks 7-12 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Numbers represent participants with analyzable data.

Baseline characteristics by cohort

Measure	Entire Study Population n=126 Participants Includes groups randomized to receive MgCl first and no intervention first
Age, Continuous	52.4 years STANDARD_DEVIATION 12.9 • n=5 Participants • Numbers represent participants with analyzable data.
Sex: Female, Male Female	78 Participants n=5 Participants • Numbers reflect participants with analyzable data
Sex: Female, Male Male	48 Participants n=5 Participants • Numbers reflect participants with analyzable data
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	123 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	126 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Number of participants with analyzable data.

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.

Outcome measures

Measure	MgCl n=112 Participants 6 weeks of MgCl supplements	Control n=112 Participants 6 weeks of no supplements
Patient Health Questionnaire-9	-4.28 score on a scale Interval -4.99 to -3.56	-0.09 score on a scale Interval -0.9 to 0.72

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MgCl n=112 Participants 6 weeks of MgCl supplements	Control n=112 Participants 6 weeks of no supplements
Generalized Anxiety Disorder 7 Item Questionnaire	-3.88 scores on a scale Interval -4.7 to -3.07	0.80 scores on a scale Interval 0.02 to 1.59

SECONDARY outcome

Timeframe: 12 weeks

Population: headaches

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)

Outcome measures

Measure	MgCl n=112 Participants 6 weeks of MgCl supplements	Control n=112 Participants 6 weeks of no supplements
Change in Headaches While Taking Supplements	-0.14 score on a scale Interval -0.25 to -0.03	-0.14 score on a scale Interval -0.25 to -0.03

Adverse Events

Mg Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emily Tarleton, MS, RD

University of Vermont

Phone: 802-847-4730

Email: emily.tarleton@uvm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place