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

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

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).

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Centanafadine; Drug: Escitalopram

• Study Type: Interventional
• Enrollment (Estimated): 336
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Otsuka Call Center; Phone Number: 844-687-8522; Email: OtsukaUS@druginfo.com

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78754
      • Recruiting
      • For additional information regarding sites, contact 844-687-8522

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode.
• History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.

Key Exclusion Criteria:

• Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.
• Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder.
• Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
• Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo + Placebo	Drug: Placebo; capsule
Experimental: Centanafadine + Placebo	Drug: Placebo; capsule; Drug: Centanafadine; capsule
Experimental: Centanafadine + Escitalopram	Drug: Centanafadine; capsule; Drug: Escitalopram; capsule
Active Comparator: Escitalopram + Placebo	Drug: Placebo; capsule; Drug: Escitalopram; capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.	Baseline, Week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Estimated): January 17, 2025
• Study Completion (Estimated): January 17, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Mood Disorders; Depressive Disorder; MDD; Mental Disorders; Depressive Disorder, Major; SSRI; Behavioral Symptoms; Centanafadine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Escitalopram
• Other Study ID Numbers: 405-201-00062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No