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

BlackThorn Therapeutics

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: BTRX-246040 oral capsule(s); Drug: Placebo oral capsule(s)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03193398

NEP-MDD-201

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

BTRX-246040

Experimental group

Description:

40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.

Treatment:

Drug: BTRX-246040 oral capsule(s)

Placebo

Placebo Comparator group

Description:

administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.

Treatment:

Drug: Placebo oral capsule(s)