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
1 other identifier
interventional
337
1 country
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Sep 2022
Typical duration for phase_2 major-depressive-disorder
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
September 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2025
CompletedMay 30, 2025
May 1, 2025
2.7 years
September 7, 2022
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
Baseline, Week 6
Study Arms (4)
Centanafadine + Placebo
EXPERIMENTALCentanafadine + Escitalopram
EXPERIMENTALEscitalopram + Placebo
ACTIVE COMPARATORPlacebo + Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Yuma CNS Research
Yuma, Arizona, 85365-4905, United States
SanRo Clinical Research Group LLC
Bryant, Arkansas, 72022-9252, United States
Behavioral Research Specialists-California-Irvine
Glendale, California, 91206-4282, United States
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS
Lafayette, California, 94549, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, 93534-5504, United States
Synergy Research Centers - SRC - ERG - PPDS
Lemon Grove, California, 91945-2956, United States
ATP Clinical Research
Orange, California, 92866, United States
NRC Research Institute - Orange - PPDS
Orange, California, 92868-2847, United States
Prospective Research Innovations
Rancho Cucamonga, California, 91730-4850, United States
Anderson Clinical Research - ClinEdge - PPDS
Redlands, California, 92374-4555, United States
Lumos Clinical Research
San Jose, California, 95124-4108, United States
Syrentis Clinical Research
Santa Ana, California, 92705-8675, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403-1747, United States
Viking Clinical Research Ltd
Temecula, California, 92591-5285, United States
CNS Clinical Research Group
Coral Springs, Florida, 33067-4644, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912-4367, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256-6040, United States
South Florida Research Phase I - IV
Miami Springs, Florida, 33166-7225, United States
Behavioral Clinical Research, Inc
North Miami, Florida, 33161-5832, United States
Clinical Neuroscience Solutions Inc
Orlando, Florida, 32801-2987, United States
University of South Florida
Tampa, Florida, 33613-4706, United States
Atlanta Center for Medical Research - CenExel ACMR - PPDS
Atlanta, Georgia, 30331, United States
iResearch Atlanta - CenExel - PPDS
Decatur, Georgia, 30030-3438, United States
Psych Atlanta
Marietta, Georgia, 30060-2585, United States
Accelerated Clinical Trials,LLC
Peachtree Corners, Georgia, 30071-2655, United States
Northwest Clinical Trials
Boise, Idaho, 83704-8638, United States
Flourish Research - Andersonville - PPDS
Chicago, Illinois, 60640-2831, United States
Revive Research Institute
Elgin, Illinois, 60123-9215, United States
American Medical Research Inc
Oak Brook, Illinois, 60523-1818, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, 71101-4603, United States
MTP Psychiatry, LLC
Baltimore, Maryland, 21229-1506, United States
Precise Research Centers - ClinEdge - PPDS
Flowood, Mississippi, 39232, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368-8223, United States
Bio Behavioral Health
Toms River, New Jersey, 08755-6434, United States
Integrative Clinical Trials - Hunt - PPDS
Brooklyn, New York, 11229-3576, United States
SPRI Clinical Trials, LLC - ERG - PPDS
Brooklyn, New York, 11235-5660, United States
Fieve Clinical Research
New York, New York, 10017-1945, United States
Manhattan Behavioral Medicine
New York, New York, 10036-4543, United States
Finger Lakes Clinical Research
Rochester, New York, 14618-1609, United States
Richmond Behavioral Associates
Staten Island, New York, 10314, United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, 45215-2123, United States
University of Cincinnati
Cincinnati, Ohio, 45219-2498, United States
Charak Clinical Research Center
Garfield Heights, Ohio, 44125-2946, United States
Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS
North Canton, Ohio, 44720-1528, United States
Cutting Edge Research
Oklahoma City, Oklahoma, 73116-1423, United States
Summit Research Network, Inc. - Portland - Headlands - PPDS
Portland, Oregon, 97210-5354, United States
Suburban Research Associates - ATLAS - West Chester - PPDS
West Chester, Pennsylvania, 19380-4370, United States
LLM Research - South Carolina
Myrtle Beach, South Carolina, 29577-5898, United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119-4806, United States
FutureSearch Trials of Dallas, LLC - IVY - PPDS
Dallas, Texas, 75251, United States
InSite Clinical Research, LLC
DeSoto, Texas, 75115-2066, United States
Houston Mind & Brain
Houston, Texas, 77055-6349, United States
Innovative Medical Research of Texas
Houston, Texas, 77065-4776, United States
Red Oak Psychiatry Associates P A
Houston, Texas, 77090-2607, United States
University Hills Clinical Research
Irving, Texas, 75062-2762, United States
AIM Trials
Plano, Texas, 75093-8346, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309-1608, United States
Alpine Research Organization, Inc
Clinton, Utah, 84015-8563, United States
Cedar Clinical Research - IVY - PPDS
Draper, Utah, 84020-9884, United States
The Memory Clinic
Bennington, Vermont, 05201-9810, United States
University of Virginia
Charlottesville, Virginia, 22903-9353, United States
Core Clinical Research
Everett, Washington, 98201-4077, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 10, 2022
Study Start
September 12, 2022
Primary Completion
May 16, 2025
Study Completion
May 16, 2025
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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/
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.