Axsome Therapeutics has enrolled the first patient in the Assessing Clinical Episodes in Depression (ASCEND) trial of AXS-05 to treat major depressive disorder (MDD), a serious condition characterised by depressed mood or a loss of interest or pleasure in daily activities.

The double-blind, randomised, active-controlled, multi-centre Phase ll trial aims to enrol around 74 patients.

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Under the trial, the patients will be randomised in a 1:1 ratio to receive AXS-05 or bupropion for a period of six weeks.

The trial will evaluate the safety parameters, Montgomery-Åsberg Depression Rating Scale (MADRS), other clinician-rated scales, as well as patient-reported outcome measures throughout the study duration.

Topline results from the ASCEND trial are scheduled to be released in the second half of this year.

“AXS-05 is now being studied in four clinical trials across four indications.”

Axsome Therapeutics CEO Herriot Tabuteau said: “AXS-05 features multiple novel mechanisms of action, which, along with the recent positive interim futility analysis of the Phase ll trial in TRD, support its evaluation in the broader MDD population.

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“AXS-05 is now being studied in four clinical trials across four indications.

“We look forward to a busy second half of 2018 for AXS-05, with anticipated topline results from the Phase ll ASCEND trial in MDD, the first interim analysis of the Phase ll/lll ADVANCE-1 trial in Alzheimer’s disease agitation, and the next and final interim analysis for efficacy of the Phase lll STRIDE-1 trial in TRD.”

AXS-05 is a new, oral, glutamatergic and monoaminergic investigational medicine that features dextromethorphan and bupropion.

It is currently under development for the treatment of central nervous system (CNS) disorders.