Trial of Centanafadine Efficacy and Safety as Monotherapy... | NCT05536414

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2022Actual

Primary Completion Date

May 16, 2025Actual

Completion Date

May 16, 2025Actual

First Submitted Date

Sep 7, 2022

First Submission Date that Met QC Criteria

Sep 7, 2022

First Posted Date

Sep 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

May 5, 2026

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

May 30, 2025Actual

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

337Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Centanafadine + Placebo	Experimental	Drug: Centanafadine Drug: Placebo
Centanafadine + Escitalopram	Experimental	Drug: Centanafadine Drug: Escitalopram
Escitalopram + Placebo	Active Comparator	Drug: Escitalopram Drug: Placebo
Placebo + Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Centanafadine	Drug	capsule	Centanafadine + Escitalopram Centanafadine + Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yuma CNS Research		Yuma	Arizona	85365-4905	United States
SanRo Clinical Research Group LLC

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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.

Access Criteria

Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

URL

https://clinical-trials.otsuka.com

ID	Term
D003865	Depressive Disorder, Major
D003866	Depressive Disorder
D003863	Depression
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds