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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- University of Miami
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Magnesium levels in treatment resistant mild and moderate depression
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
John E. Lewis
Associate Professor of Psychiatry and Behavioral Sciences
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Potential participants must be English speaking.
- •Between the ages of 21 and
- •Overall healthy and have no difficulty with digestion or absorption of food
- •Have treatment-resistant depression defined as failure of clinical improvement after 6 weeks with an approved dose of a Selective Serotonin Uptake Inhibitor (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor (SNRI), Selective Noradrenaline Reuptake Inhibitor (NRI), tricyclic antidepressant, or bupropion.
- •Willing to provide informed consent to participate in the study.
- •Willing and able to comply with all study procedures and data recording obligations for the entire length of the study.
- •Able and willing to abstain from alcohol from 48 hours prior to the first intravenous infusion until after completion of the post-treatment follow-up visit (Day 2) and from 48 hours prior to the second intravenous infusion until after completion of the post-treatment follow-up visit (Day 8).
- •If currently taking an SSRI for more than 90 days, have maintained the same dose for the past 90 days.
- •A non-smoker or have quit smoking at least 6 months ago.
Exclusion Criteria
- •Currently enrolled (or have been in the last 30 days) in another research trial for investigative nutritional or other therapies thought to have an impact on depression.
- •Currently taking a medication or nutritional supplement containing more than 100% RDA of magnesium (for women over age 31, it is 320 mg/day and for men over age 31, it is 420 mg/day) and unable to discontinue using it 14 days prior to the Day 1 visit. (Current use must be stopped 2 weeks before enrolling in the study and during trial.)
- •Diagnosed with any medical condition, including diabetes, cardiovascular disease, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric (except for depression), immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment that would preclude participation in the study.
- •Taking Digoxin (used to treat congestive heart failure and to slow the heart rate in patients with atrial fibrillation.
- •Taking penicillamine (also known as Cuprimine or Depen for Wilson's disease or rheumatoid arthritis).
- •Taking any antibiotic (including tetracycline or a quinolone).
- •Taking any psychotropic medication for any indication, except sedatives for sleep such as Zolpidem, in addition to the SSRI, SNRI, NRI, tricyclic antidepressant, or bupropion in the course of treatment for your depression.
- •Taking a SSRI, SNRI, NRI, tricyclic antidepressant, or bupropion for less than 90 days or unable to maintain the same therapeutic regimen throughout the study duration.
- •A history of any medical or surgical procedure that would preclude participation in the study.
- •Diagnosed with gastrointestinal disorders that could lead to uncertain resorption of the study supplements.
Outcomes
Primary Outcomes
Magnesium levels in treatment resistant mild and moderate depression
Time Frame: 8 days
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.
Self reported depression measures
Time Frame: 8 days
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 Outcomes
- Correlation of magnesium levels with self reported measures of depression(8 days)