Double-blind, randomized crossover study of intravenous infusion of … – PR Newswire (press release)

Studies have shown that 30-50 percent of patients diagnosed with MDD do not respond to an initial anti-depressant trial, while 15 percent will continue to suffer from depression. Treatment-resistant depression commonly refers to major depressive episodes that have not responded to two adequate trials of antidepressant monotherapy.

In a recent study conducted at the University of Miami Miller School of Medicine and published in Psychiatry and Clinical Neurosciences (2016), 12 subjects with mild or moderate TRD were randomized into a double-blind crossover trial to receive an intravenous (IV) infusion of 4 g of magnesium sulfate in five percent dextrose or an IV infusion of five percent dextrose (placebo) with a one week washout period in between.

Subjects were assessed before and after the intervention for serum and urine magnesium. Assessment tools included the Hamilton Rating Scale for Depression (HAM-D), which is a clinician-used questionnaire to assess severity of depressive symptoms related to mood, feelings of guilt, suicidal ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The Patient Health Questionnaire-9 (PHQ-9) was also utilized and is a brief self-report tool that can be rapidly used by clinicians to determine the response to treatment.

Study results indicated a significant increase in the serum magnesium level in response to the magnesium sulfate IV infusion and as the serum magnesium increased from baseline to day seven, the PHQ-9 score significantly decreased during the same timeframe suggesting an improvement in depression symptoms. The change in the score for the HAM-D scale from day two to eight was also positively correlated with the PHQ-9 score change during the same time period. It was also noted that the 24-hour post-infusion scores on the HAM-D and PHQ-9 did not change. The treatment was well tolerated, and no serious adverse events were noted.

Researchers concluded that IV infusion of magnesium sulfate increased the serum level of magnesium, which was correlated with improved depression symptoms according to the PHQ-9. Improvements in the PHQ-9 and HAM-D were positively correlated. This is in alignment with current literature noting that the administration of magnesium may be beneficial for patients with TRD. Additional research is needed to assess the use of the various forms of magnesium as an alternative to the current standard of care for TRD. Funding for this investigation was provided by a grant from the Life Extension Foundation, Fort Lauderdale, Fla.

For more information contact John E. Lewis, Ph.D., the principal investigator of the study at the University of Miami Miller School of Medicine at jelewis@miami.edu or Dr. Steven Hirsh, director of clinical research, Life Extension Clinical Research, Inc. at shirsh@lifeextension.com.

Mehdi S, Atlas S, Qadir S et al. Double-blind, randomized crossover study of intravenous infusion of magnesium sulfate versus 5% dextrose on depressive symptoms in adults with treatment-resistant depression. Psychiatry Clin Neurosci 2016 Nov 10 doi: 10.1111/pcn.12480.

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SOURCE Life Extension

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