Minerva Neurosciences Announces Enrollment of First Patient in Phase 2b Trial Comparing Seltorexant (MIN-202) Versus Quetiapine as Adjunctive Therapy to Antidepressants in Patients With Major Depressive Disorder
The primary objective of this multi-center, double-blind, randomized, flexible-dose, parallel-group study is to assess the efficacy of flexibly dosed seltorexant compared to flexibly dosed quetiapine as adjunctive therapy to a baseline antidepressant drug in delaying time to all-cause discontinuation of study drug over a 6-month treatment period. Time to all-cause discontinuation is defined as the number of days from administration of the first dose of study drug to administration of the last dose of study drug.
“Preclinical studies have demonstrated that inhibition of orexin 2 receptors diminishes stress-induced activation of the HPA (hypothalamic-pituitary-adrenal) axis, a major part of the neuroendocrine system that is implicated in the pathophysiology of mood disorders and controls reactions to stress,” said Dr.
The trial consists of three phases: a screening phase lasting up to four weeks, a six-month double-blind treatment phase and a two-week follow-up phase. Approximately 100 patients 18 to 64 years of age are planned to be randomized at approximately 34 sites in the U.S. to receive either flexibly dosed seltorexant, 20 milligrams (mg) or 40 mg, or flexibly dosed quetiapine XR, 150 mg or 300 mg. Subjects will continue to take their baseline antidepressant therapy of either an SSRI (selective serotonin reuptake inhibitor) or an SNRI (serotonin-norepinephrine reuptake inhibitor) at the same dose throughout the screening, double-blind and follow-up phases.
About Seltorexant (MIN-202)
Seltorexant is a selective orexin 2 receptor antagonist under co-development by
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to: the timing and results of future clinical milestones with seltorexant in major depressive disorder, including the timing and scope of future clinical trials and results of clinical trials with this compound; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize seltorexant; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether seltorexant will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the
VP, Investor Relations/
Source: Minerva Neurosciences, Inc