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Trial Shows Drug Reduces Depression in One Day

Depressed man

(NIH.gov)

27 January 2015. A clinical trial testing a new drug to treat major depressive disorder shows the drug improved symptoms in patients after a single dose within one day. The intermediate-stage trial was conducted by Naurex Inc., a biopharmaceutical company in Evanston, Illinois and a spin-off from Northwestern University.

Naurex develops drugs for diseases of the central nervous system that stimulate N-Methyl-D-aspartate (NMDA) receptors, molecules found in synapses, a part of nerve cells that permit sending and receiving of signals. NMDA receptors help keep synapses flexible, which affects memory, learning, and development of the central nervous system. Naurex uses this platform to develop drugs to treat mood and anxiety disorders, cognitive disorders, neurodegenerative diseases, developmental disorders, neuropathic pain, and addiction.

The clinical trial tested Naurex’s compound code-named NRX-1074 in adult patients with major depressive disorder, an acute form of depression that affects thought and behavior of people with the condition. The disorder often interferes with daily family and work life, and requires clinical intervention to treat effectively. Counseling and medications are often prescribed as treatments.

Naurex says NRX-1074 is a follow-on medication to its lead product rapastinel, and while chemically similar, is more potent and can be given as an oral drug. However, the trial used intravenous injections in doses of 1, 5, and 10 milligrams, or a placebo, with the 140 patients; the oral form of the drug will be tested in a later study. The trial looked primarily at scores on the Hamilton Depression Rating Scale, a standard assessment test with 17 items measuring the patients’ behaviors related to or indicative of depression. Researchers also gathered data on other symptom assessment tests, as well as safety of the different dosage levels.

The results show patients receiving the highest (10 milligram) dose of NRX-1074 report Hamilton Depression Rating Scale scores 14 points lower than patients receiving the placebo, as soon as 1 day following treatment. According to the company, the effect size of the antidepression efficacy — a quantitative measure of strength of a statistical relationship — after 24 hours is more than twice the effect size reported for other antidepression drugs taken in multiple doses over 4 to 6 weeks.

In addition, 72 percent of patients receiving the highest NRX-1074 dose reported a reduction of half or more in Hamilton Depression Rating Scale scores after 24 hours, compared to 39 percent for patients receiving the placebo. Naurex says NRX-1074 was well tolerated with no adverse reactions reported, or patients dropping out of the study due to adverse events.

Results of the study, conducted at 12 sites in the U.S., will be used to determine dosages for the next study of repeated doses of NRX-1074, taken in oral form, among patients with major depressive disorder.

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