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

• Status: Completed
• Trial end date: 2018-12-12
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BlackThorn Therapeutics, Inc.

Criteria

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.