DepressionNCT01597167
Magnesium Sulfate Versus 5% Dextrose With Treatment Resistant Depression
A study testing Magnesium sulfate in people with Depression, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential participants must be English speaking.
- Between the ages of 21 and 70.
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
- Pregnant, plan to become pregnant, or currently breast feeding.
- 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).
- Systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg.
- 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.
- 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.
- A history of substance abuse (e.g., alcohol, opiates, benzodiazepines, or amphetamines).
- 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.).
- Diagnosed with a terminal illness.
- Donated blood in the last 30 days.
- Any severe, acute illness within the last five days.
- Have a pacemaker or internal medical device.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Clinical Research Building
Miami, Florida, 33136
About this study
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
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.
Read the detailed description
Purpose:
- 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.
- Correlation of intracellular magnesium (EXATEST), urine magnesium, and serum magnesium as well as sensitivity to the IV magnesium infusion.
- To assess the effectiveness of magnesium sulfate infusion on treatment resistant mild and moderate depression patients.
Objectives:
Primary:
- 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.
- 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:
- 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.
- Conditions
- Depression
- Being tested
- Magnesium sulfate
- Keywords
- mild moderate treatment-resistant depression, magnesium sulfate
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDietary supplement
4 grams magnesium sulfate in 100 ml IV over 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate crossover | Experimental | IV infusion of magnesium sulfate followed by 5-day washout period and crossover to 5% dextrose (placebo) Receives: Dietary Supplement: Magnesium sulfate |
| Placebo crossover | Placebo comparator | IV infusion of 5% dextrose with 5 day washout and crossover to magnesium sulfate Receives: Dietary Supplement: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnesium levels in treatment resistant mild and moderate depression
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.
Measured: 8 days
Self reported depression measures
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.
Measured: 8 days
Secondary outcomes (1)
Correlation of magnesium levels with self reported measures of depression
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
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Life Extension Foundation Inc.
- Responsible party
- Principal investigator, John E. Lewis, University of Miami
- Investigators
- John Lewis, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597167
- Sponsor's protocol ID
- 20110168
- Status last verified
- Jan 2016
- First submitted
- 9 May 2012
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01597167
- Acronym / sponsor ID
- 20110168
- Conditions
- Depression
- Keywords
- mild moderate treatment-resistant depression, magnesium sulfate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Life Extension Foundation Inc.
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Correlation of intracellular magnesium (EXATEST), urine magnesium, and serum magnesium as well as sensitivity to the IV magnesium infusion.
- To assess the effectiveness of magnesium sulfate infusion on treatment resistant mild and moderate depression patients.
Objectives:
Primary:
- 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.
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate crossover | Experimental | Dietary Supplement: Magnesium sulfateIV infusion of magnesium sulfate followed by 5-day washout period and crossover to 5% dextrose (placebo) |
| Placebo crossover | Placebo comparator | Dietary Supplement: Magnesium sulfateIV infusion of 5% dextrose with 5 day washout and crossover to magnesium sulfate |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Potential participants must be English speaking.
- Between the ages of 21 and 70.
- 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.
Key exclusion criteria (21 listed)
- 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).
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 |
|---|---|---|
| Magnesium sulfate4 grams magnesium sulfate in 100 ml IV over 4 hours | Dietary supplement | Magnesium sulfate crossover, Placebo crossover |
Primary outcome
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.
1 secondary outcome
Correlation of magnesium levels with self reported measures of depression
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
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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.
John Lewis, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate in people with Depression, run by University of Miami 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 9 inclusion and 21 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 21 Jan 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Magnesium levels in treatment resistant mild and moderate depression (time frame: 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2016.