Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01597167
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2012-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Magnesium Sulfate Versus 5% Dextrose With Treatment Resistant Depression
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
A Double-blinded Randomized Study of IV Infusion of Magnesium Sulfate Versus 5% Dextrose in a Crossover Design in Male and Female Volunteers With Treatment Resistant Depression
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study is a 1-week, randomized, double-blind, placebo-controlled, trial to evaluate the efficacy of an IV infusion of magnesium sulfate on symptoms of treatment resistant mild and moderate depression in 20 males and females (21-70 years of age). Participants will be assessed at screening/baseline, day 1, day 2, day 7, and day 8. Each subject will be randomized in a double-blind fashion to receive either IV infusion of magnesium sulfate or 5% dextrose followed by a washout period of 5 days then crossover to receive either IV infusion of 5% dextrose or magnesium sulfate.
Detailed Description:
Purpose:
1. To determine the magnesium deficient status in treatment-resistant mild and moderate depression patients via 24-hour urine magnesium assessment before and after IV magnesium infusion.
2. Correlation of intracellular magnesium (EXATEST), urine magnesium, and serum magnesium as well as sensitivity to the IV magnesium infusion.
3. To assess the effectiveness of magnesium sulfate infusion on treatment resistant mild and moderate depression patients.
Objectives:
Primary:
1. To investigate the magnesium deficient status in treatment-resistant mild and moderate depression patients via assay of 24-hour urine magnesium, blood magnesium, and EXATEST of intracellular magnesium of epithelial cells before and after IV infusion.
2. To assess the effectiveness of the magnesium sulfate infusion on the mean change in scores on the Hamilton Rating Scale for Depression and the Patient Health Questionnaire (PHQ-9) for depression.
Secondary:
1\. To correlate the levels of magnesium with the scores on the Hamilton Rating Scale for Depression and the Patient Health Questionnaire (PHQ-9) for depression.
1. To determine the magnesium deficient status in treatment-resistant mild and moderate depression patients via 24-hour urine magnesium assessment before and after IV magnesium infusion.
2. Correlation of intracellular magnesium (EXATEST), urine magnesium, and serum magnesium as well as sensitivity to the IV magnesium infusion.
3. To assess the effectiveness of magnesium sulfate infusion on treatment resistant mild and moderate depression patients.
Objectives:
Primary:
1. To investigate the magnesium deficient status in treatment-resistant mild and moderate depression patients via assay of 24-hour urine magnesium, blood magnesium, and EXATEST of intracellular magnesium of epithelial cells before and after IV infusion.
2. To assess the effectiveness of the magnesium sulfate infusion on the mean change in scores on the Hamilton Rating Scale for Depression and the Patient Health Questionnaire (PHQ-9) for depression.
Secondary:
1\. To correlate the levels of magnesium with the scores on the Hamilton Rating Scale for Depression and the Patient Health Questionnaire (PHQ-9) for depression.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: