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Magnesium Sulfate Versus 5% Dextrose With Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT01597167
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : January 21, 2016
Sponsor:
Collaborator:
Life Extension Foundation Inc.
Information provided by (Responsible Party):
John E. Lewis, University of Miami

Tracking Information
First Submitted Date  ICMJE May 9, 2012
First Posted Date  ICMJE May 11, 2012
Last Update Posted Date January 21, 2016
Study Start Date  ICMJE October 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
  • 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 Questionnnaire (PHQ-9) for depression.
Change History Complete list of historical versions of study NCT01597167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
Correlation of magnesium levels with self reported measures of depression [ Time Frame: 8 days ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnesium Sulfate Versus 5% Dextrose With Treatment Resistant Depression
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE Dietary Supplement: Magnesium sulfate
4 grams magnesium sulfate in 100 ml IV over 4 hours
Study Arms  ICMJE
  • Experimental: Magnesium sulfate crossover
    IV infusion of magnesium sulfate followed by 5-day washout period and crossover to 5% dextrose (placebo)
    Intervention: Dietary Supplement: Magnesium sulfate
  • Placebo Comparator: Placebo crossover
    IV infusion of 5% dextrose with 5 day washout and crossover to magnesium sulfate
    Intervention: Dietary Supplement: Magnesium sulfate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2012)
20
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Potential participants must be English speaking.
  2. Between the ages of 21 and 70.
  3. Overall healthy and have no difficulty with digestion or absorption of food
  4. 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.
  5. Willing to provide informed consent to participate in the study.
  6. Willing and able to comply with all study procedures and data recording obligations for the entire length of the study.
  7. 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).
  8. If currently taking an SSRI for more than 90 days, have maintained the same dose for the past 90 days.
  9. A non-smoker or have quit smoking at least 6 months ago.

Exclusion Criteria:

  1. 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.
  2. 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.)
  3. 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.
  4. Taking Digoxin (used to treat congestive heart failure and to slow the heart rate in patients with atrial fibrillation.
  5. Taking penicillamine (also known as Cuprimine or Depen for Wilson's disease or rheumatoid arthritis).
  6. Taking any antibiotic (including tetracycline or a quinolone).
  7. 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.
  8. 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.
  9. A history of any medical or surgical procedure that would preclude participation in the study.
  10. Diagnosed with gastrointestinal disorders that could lead to uncertain resorption of the study supplements.
  11. Pregnant, plan to become pregnant, or currently breast feeding.
  12. Unwilling to avoid pregnancy (use medically-acceptable birth control method during the study with at least one method for the period of one month prior to beginning of the study until at least three months after study completion or are surgically sterile or postmenopausal (at least 12 months without a period).
  13. Systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg.
  14. Had any of the following abnormal laboratory test values: (a) bilirubin > 2x upper normal limit, (b) AST and ALT > 2x upper normal limit, (c) serum creatinine > 1.5 mg/dl, (d) blood glucose below 80 mg/dl or above 110 mg/dl, (e) calcium level < 8.6 mg/dl, or (f) triglycerides >200 mg/dl.
  15. Currently undergoing any chemotherapy or radiation treatment for cancer, have an active malignancy, or have had within the past 5 years any type of malignancy, other than non-melanomatous skin malignancies.
  16. A history of substance abuse (e.g., alcohol, opiates, benzodiazepines, or amphetamines).
  17. Currently consume more than 6 standard alcoholic drinks a week (A standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor.).
  18. Diagnosed with a terminal illness.
  19. Donated blood in the last 30 days.
  20. Any severe, acute illness within the last five days.
  21. Have a pacemaker or internal medical device.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01597167
Other Study ID Numbers  ICMJE 20110168
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John E. Lewis, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Life Extension Foundation Inc.
Investigators  ICMJE
Principal Investigator: John Lewis, PhD University of Miami
PRS Account University of Miami
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP