AXS-05-MDD-301: a randomized, double-blind, placebo-controlled trial of AXS-05 in subjects with major glutamatergic neurotransmission disorder.
Altered glutamatergic neurotransmission has been implicated in the pathogenesis of depression. This trial evaluated the efficacy and protection of AXS-05 (dextromethorphan-bupropion), an oral N-methyl-D-aspartate receptor antagonist and σ1 receptor agonist, inside the remedy for the most important depressive disorder.
This double-blind, segment three trial, turned into conducted between patients with a DSM-five prognosis of MDD had been randomized in a 1:1 ratio to acquire dextromethorphan-bupropion (45 mg-105 mg pill) or placebo, orally (once each day for days 1-3, two times every day thereafter) for 6 weeks. The primary endpoint became the exchange from baseline to week 6 within the 1st viscount Montgomery of Alamein-Asberg depression rating Scale total score. different efficacy endpoints and variables covered changes from baseline at weeks 1 and 2, scientific remission.
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