The study, entitled “A double blinded, randomized, placebo-controlled study of an IV infusion of Magnesium Sulfate vs. 5% Dextrose in a crossover design in male and female volunteers with treatment resistant depression,” is sponsored by Fort Lauderdale, Fla.-based Life Extension Foundation, a non-profit organization dedicated to finding new scientific methods to enhance and expand the healthy human life span, in conjunction with the research division at the University of Miami under the direction of John E. Lewis, associate professor of psychiatry and behavioral sciences.
This clinical trial will assess the effectiveness of an intravenous magnesium sulfate infusion in participants who display symptoms of treatment resistant mild and moderate depression. According to Life Sciences, each of the 20 study subjects will be randomized in a double-blinded fashion to receive either an intravenous infusion of magnesium sulfate or placebo containing 5% dextrose. This will be followed by a washout period and then crossover to receive the product that was not initially received.
“The magnesium deficient status will be determined via assessment of the magnesium level in the blood and urine before and after each infusion,” said Dr. Steven Hirsh, director of clinical research at Life Extension Clinical Research, Inc. “The effectiveness of the infusion will be determined through scores attained on a rating scale for depression as well as a patient health questionnaire for depression.” A correlation will then be conducted with levels of magnesium and these scores.
Dr. Hirsch told Nutraceuticals World a variety of factors inspired the study of this type of therapy. “Some interesting published studies noted an association between low magnesium levels and depressed mood,” he said. “In a study involving 55 diabetic patients, it was observed that serum magnesium levels were significantly lower among those in depressive states when compared to controls. A 2008 clinical trial revealed that magnesium administration was as effective as the anti-depressant drug imipramine in improving depression symptoms. Also, animals on a low magnesium diet had increased immobility time indicating depression-like behavior.”
He went on to explain that he and his colleagues are hoping to prove that magnesium is indeed effective. “Data is being gathered to help determine if magnesium infusion can improve depression symptoms in individuals with treatment-resistant mild to moderate depression,” he said. “Established questionnaires called the Hamilton Rating Scale, and the Patient Health Questionnaire (PHQ-9), are being used to determine the level of depression in subjects. Based on past human and animal research, the hypothesis is that by improving magnesium status, there will also be improvement in the scores for these two questionnaires.”
As for what makes magnesium such an important influence in the treatment of depression, Dr. Hirsch said magnesium plays a key role in the production of neurotransmitters that regulate mood. “Studies show that magnesium deficiency makes brain cells more susceptible to overstimulation of NMDA (N-methyl-D-aspartate) receptors,” he said. “These receptors are significant because when they get overexcited it can inhibit proper nerve function. Studies show that magnesium opposes NMDA receptors. Substances that oppose NMDA receptors (called NMDA receptor antagonists) can have anti-anxiety and anti-depressant properties.
Dr. Hirsch said he expected the study’s preliminary results to be available by the second quarter of 2013.
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