['major depressive disorder']
['btrx-246040 oral capsule(s)', 'placebo oral capsule(s)']

        Inclusion Criteria:

          -  Patients with a diagnosis of MDD as defined by DSM-5 criteria and have had at least 1
             prior major depressive episode in the past 10 years

          -  Patients must present with a new current episode of MDD and the duration of the
             current episode must be at least 4 weeks but not longer than 18 months.

          -  At Visit 1 (screening) and Visit 2 (baseline), patients must have clinically
             significant depressive symptoms defined by tandem (investigator- and
             computer-administered) Montgomery-Asberg Depression Rating Scale (MADRS) total scores
             ≥ 26 with a difference of ≤ 7 points between the Investigator- and
             computer-administered MADRS total scores

          -  Patients must have a CGI-S score ≥ 4 at Visit 2 (baseline).

        Exclusion Criteria:

          -  Patients who present with any current DSM-5 disorder other than MDD which is the focus
             of treatment.

          -  Patients who are homicidal in the opinion of the Investigator or are at suicidal risk
             (any suicide attempts within 12 months prior to Visit 1 [screening] or any suicidal
             intent, including a plan, within 3 months prior to Visit 1 [screening]; C-SSRS answer
             of "YES" on item 4 or 5 [suicidal ideation]; Investigator- or computer-administered
             MADRS score of ≥ 5 on item 10 [suicidal thoughts]; by Investigator clinical
             evaluation).

          -  Patients cannot have any history of substance or alcohol use disorder within 12 months
             prior to Visit 1 (screening) per DSM-5 criteria

          -  Patients must not have a clinically significant comorbid disease.
      