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

Primary Purpose

Major Depressive Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Centanafadine (328.8 mg)

Escitalopram

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, Centanafadine, SSRI, Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders, Behavioral Symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

For additional information regarding sites, contact 844-687-8522Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

328.8 mg dose Total Daily Dose (TDD) Centanafadine + Placebo

328.8 mg dose Total Daily Dose (TDD) Centanafadine + Escitalopram

Escitalopram + Placebo

Placebo + Placebo

Arm Description

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.

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.

1 escitalopram XR capsule and 2 placebo XR capsules to be taken once daily in the morning.

3 placebo XR capsules to be taken once daily in the morning.

Outcomes

Primary Outcome Measures

Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.

Secondary Outcome Measures

Change from baseline to Week 6 in Clinical Global Impression - Severity (CGI-S) score

Mean Clinical Global Impression - Change (CGI-C) score

Change from baseline to Week 6 in Patient Global Impression - Severity (PGI-S) score

Mean Patient Global Impression - Change (PGI-C) score

Change from baseline to Week 6 in Symptoms of Major Depressive Disorder Scale (SMDDS) Total score

Change from screening to Week 6 in 6-item Short-Form Health Survey Version 2 (SF-36v2)

Change from screening in Apathy Evaluation Scale - Self-rated (AES-S) score

Percentage of Subjects with MADRS Response (where response is defined as 50% reduction in MADRS Total score from baseline)

Percentage of Subjects with MADRS Remission (where remission is defined as MADRS Total score ≤ 10)

Full Information

NCT ID

NCT05536414

First Posted

September 7, 2022

Last Updated

June 27, 2023

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05536414

Brief Title

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

Acronym

JUNIPER

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 12, 2022 (Actual)

Primary Completion Date

April 18, 2024 (Anticipated)

Study Completion Date

April 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

MDD, Centanafadine, SSRI, Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders, Behavioral Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

328.8 mg dose Total Daily Dose (TDD) Centanafadine + Placebo

Arm Type

Experimental

Arm Description

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.

Arm Title

328.8 mg dose Total Daily Dose (TDD) Centanafadine + Escitalopram

Arm Type

Experimental

Arm Description

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.

Arm Title

Escitalopram + Placebo

Arm Type

Active Comparator

Arm Description

1 escitalopram XR capsule and 2 placebo XR capsules to be taken once daily in the morning.

Arm Title

Placebo + Placebo

Arm Type

Placebo Comparator

Arm Description

3 placebo XR capsules to be taken once daily in the morning.

Intervention Type

Drug

Intervention Name(s)

Centanafadine (328.8 mg)

Intervention Description

Oral, extended-release (XR) capsule

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

Oral, extended-release (XR) capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral, extended-release (XR) capsule

Primary Outcome Measure Information:

Title

Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.

Time Frame

Baseline, Weeks 1, 2, 4, and 6

Secondary Outcome Measure Information:

Title

Change from baseline to Week 6 in Clinical Global Impression - Severity (CGI-S) score

Time Frame

Baseline, Weeks 1, 2, 4, and 6

Title

Mean Clinical Global Impression - Change (CGI-C) score

Time Frame

Weeks 1, 2, 4, and 6

Title

Change from baseline to Week 6 in Patient Global Impression - Severity (PGI-S) score

Time Frame

Baseline, Weeks 1, 2, 4, and 6

Title

Mean Patient Global Impression - Change (PGI-C) score

Time Frame

Weeks 1, 2, 4, and 6

Title

Change from baseline to Week 6 in Symptoms of Major Depressive Disorder Scale (SMDDS) Total score

Time Frame

Baseline, Day 4, Weeks 1, 2, 4, and 6

Title

Change from screening to Week 6 in 6-item Short-Form Health Survey Version 2 (SF-36v2)

Time Frame

Screening and Week 6

Title

Change from screening in Apathy Evaluation Scale - Self-rated (AES-S) score

Time Frame

Screening and Week 6

Title

Percentage of Subjects with MADRS Response (where response is defined as 50% reduction in MADRS Total score from baseline)

Time Frame

Baseline, Weeks 1, 2, 4, and 6

Title

Percentage of Subjects with MADRS Remission (where remission is defined as MADRS Total score ≤ 10)

Time Frame

Baseline, Weeks 1, 2, 4, and 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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 have been treated with electroconvulsive therapy or transcranial magnetic stimulation for depression, have had a vagus nerve stimulation or deep brain stimulation device implanted or have been treated in the past with ketamine, arketamine, or esketamine, will be excluded.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Otsuka Call Center

Phone

844-687-8522

OtsukaUS@druginfo.com

Facility Information:

Facility Name

For additional information regarding sites, contact 844-687-8522

City

Austin

State/Province

Texas

ZIP/Postal Code

78754

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://clinical-trials.otsuka.com

Learn more about this trial

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

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