BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder

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.