Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD) who have reported inadequate response to at least 1 but no more than 3 treatments for depression in their current major depressive episode.

The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.

The trial will consist of up to a 28-day screening period, a 6-week double-blind treatment period, and a 7-day safety follow-up period. The trial is planned to be conducted on an outpatient basis with 336 subjects in the United States.

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

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Citalopram

Criteria

Key Inclusion/Exclusion Criteria:

• The trial population will consist of adult patients (18 to 65 years of age, inclusive) with a current primary diagnosis of MDD, single or recurrent episode, without psychotic features and do not meet criteria for MDD with mixed features subtype, who are in a current Major Depressive Episode (MDE) as defined by the DSM-5 criteria and confirmed by the SCID-5-CT.

• All patients must have a score of ≥ 18 on the Hamilton Depression Rating Scale - 17 item (HAM-D17) and a rating of 4 or higher on the Clinical Global Impression - Severity (CGI-S) scale at screening and baseline.

• Patients who are not willing or are unable to discontinue all prohibited medications or who have started psychotherapy within the last 3 months will be excluded.

• Patients who at any time in the past have been treated with electroconvulsive therapy or neuromodulation devices (eg, transcranial magnetic stimulation, vagus nerve stimulation, or transcranial direct current stimulation) for depression or have been treated in the past with ketamine, arketamine, or esketamine, will be excluded.