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Early Results Show Anti-Depressive Drug Effects

Man with depression

(TypographyImages, Pixabay)

15 Oct. 2019. Initial results from a clinical trial show a drug designed to supplement first-line treatments helps reduce symptoms of major depressive disorder. Findings from the trial were released today by Relmada Therapeutics Inc. in New York, developers of the treatment tested and sponsor of the study.

Relmada Therapeutics is developing the drug dextromethadone, code-named REL-1017, as an adjunctive or supplemental therapy for major depressive disorder. Depression is a widespread condition, which when it becomes persistent or severe, is called major depression, and can interfere with normal family and work life, and lead to disability. National Institute of Mental Health estimates in 2017, 17.3 million adults in the U.S., or 7.1 percent of the adult population, suffered a major depressive episode in the previous 12 months.

REL-1017 is an N-methyl-D-aspartate, or NMDA, receptor antagonist formulated by Relmada to treat several conditions, with major depressive disorder the most advanced of the drug’s applications. NMDA receptors are proteins that help keep synapses flexible, which affects memory, learning, and development of the central nervous system. The company says REL-1017 does not cause opioid-style dependencies or toxicities in patients.

The mid-stage clinical trial tested REL-1017 among 62 adults at 10 sites in the U.S. with major depressive disorder that had not responded to previous treatments. Participants were randomly assigned to receive doses of 75 or 100 milligrams of REL-1017 mixed with fruit juice on day 1 of the trial, followed by 25 or 50 milligrams of the drug respectively each day for the next six days. A comparison group of participants received only fruit juice on each of the seven days. All participants continued to take their regular anti-depression drugs during the trial, as well as REL-1017 or the placebo.

The study team looked primarily for adverse effects from REL-1017 treatments for 21 days after the start of treatments, and report no more than mild or moderate effects, but did not disclose the nature of those effects. The team says no evidence of psychosis or dissociative effects were experienced by any participants, as well as no withdrawal indicators when treatments ended.

The researchers also tracked participants’ scores on a number of standard rating scales for depression during the seven days when REL-1017 or a placebo were given and for seven days after treatments ended. The team says scores improved more on the Montgomery-Asberg Depression Rating Scale, Clinical Global Impression – Severity scale, Clinical Global Impression – Improvement scale, and Symptoms of Depression Questionnaire among participants receiving REL-1017 than participants receiving the placebo, with the differences large enough to be statistically reliable.

In addition, scores on the Montgomery-Asberg Depression Rating Scale and the two Clinical Global Impression scales were noticeably higher at day 4 of the trial among REL-1017 recipients. These results suggest the treatment’s effects happen quickly, and continue throughout the treatment period.

“This is the first clinical evidence that REL-1017 exerts a rapid and robust antidepressant effect, which continues even after treatment discontinuation,” says Ottavio Vitolo, who heads R&D at Relmada Therapeutics in a company statement. “These findings replicate what was previously observed in animal studies and support a potentially neurotrophic effect of REL-1017.”

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