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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05536414

Collaborator

(none)

336

Enrollment

Location

Arms

10.6

Anticipated Duration (Months)

31.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Centanafadine (328.8 mg) Drug: Escitalopram Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

336 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Extended-release Capsules as Monotherapy or as Adjunct to SSRI in Adult Subjects With Major Depressive Disorder

Actual Study Start Date :

Sep 12, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 328.8 mg dose Total Daily Dose (TDD) Centanafadine + Placebo 328.8 mg TDD will be administered as 2 x 164.4 mg XR capsules and 1 placebo XR capsule to be taken once daily in the morning.	Drug: Centanafadine (328.8 mg) Oral, extended-release (XR) capsule Drug: Placebo Oral, extended-release (XR) capsule
Experimental: 328.8 mg dose Total Daily Dose (TDD) Centanafadine + Escitalopram 328.8 mg TDD will be administered as 2 x 164.4 mg XR capsules and 1 escitalopram XR capsule to be taken once daily in the morning.	Drug: Centanafadine (328.8 mg) Oral, extended-release (XR) capsule Drug: Escitalopram Oral, extended-release (XR) capsule
Active Comparator: Escitalopram + Placebo 1 escitalopram XR capsule and 2 placebo XR capsules to be taken once daily in the morning.	Drug: Escitalopram Oral, extended-release (XR) capsule Drug: Placebo Oral, extended-release (XR) capsule
Placebo Comparator: Placebo + Placebo 3 placebo XR capsules to be taken once daily in the morning.	Drug: Placebo Oral, extended-release (XR) capsule

Outcome Measures

Primary Outcome Measures

Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score. [Baseline, Weeks 1, 2, 4, and 6]

Secondary Outcome Measures

Change from baseline to Week 6 in Clinical Global Impression - Severity (CGI-S) score [Baseline, Weeks 1, 2, 4, and 6]
Mean Clinical Global Impression - Change (CGI-C) score [Weeks 1, 2, 4, and 6]
Change from baseline to Week 6 in Patient Global Impression - Severity (PGI-S) score [Baseline, Weeks 1, 2, 4, and 6]
Mean Patient Global Impression - Change (PGI-C) score [Weeks 1, 2, 4, and 6]
Change from baseline to Week 6 in Symptoms of Major Depressive Disorder Scale (SMDDS) Total score [Baseline, Day 4, Weeks 1, 2, 4, and 6]
Change from screening to Week 6 in 6-item Short-Form Health Survey Version 2 (SF-36v2) [Screening and Week 6]
Change from screening in Apathy Evaluation Scale - Self-rated (AES-S) score [Screening and Week 6]
Percentage of Subjects with MADRS Response (where response is defined as 50% reduction in MADRS Total score from baseline) [Baseline, Weeks 1, 2, 4, and 6]
Percentage of Subjects with MADRS Remission (where remission is defined as MADRS Total score ≤ 10) [Baseline, Weeks 1, 2, 4, and 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.