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

NCT05536414
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Phase
Phase 2
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Recruitment status
Completed
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Participants
337
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Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Start date
2022-09-12
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Number of sites
62
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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.
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Acronym
JUNIPER
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Short title
Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-05-16
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First posted
2022-09-10
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Registry last updated
2026-05-14
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Primary completion date
2025-05-16
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Start date
2022-09-12
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Actual participants
337
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Participants
337
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
62
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Registry sponsor category
Industry
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Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05536414
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ClinicalTrials.gov ID
NCT05536414
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
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  1. Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.

    Timeframe: Baseline, Week 6

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

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.
Sources for eligibility
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  • Yuma CNS ResearchYuma, United States
  • SanRo Clinical Research Group LLCBryant, United States
  • Behavioral Research Specialists-California-IrvineGlendale, United States
  • Sunwise Clinical Research, LLC - Lafayette - IVY - PPDSLafayette, United States
  • OM Research LLC - Lancaster - ClinEdge - PPDSLancaster, United States
  • Synergy Research Centers - SRC - ERG - PPDSLemon Grove, United States
  • ATP Clinical ResearchOrange, United States
  • NRC Research Institute - Orange - PPDSOrange, United States
  • Prospective Research InnovationsRancho Cucamonga, United States
  • Anderson Clinical Research - ClinEdge - PPDSRedlands, United States
  • Lumos Clinical ResearchSan Jose, United States
  • Syrentis Clinical ResearchSanta Ana, United States
  • Schuster Medical Research InstituteSherman Oaks, United States
  • Viking Clinical Research LtdTemecula, United States
  • CNS Clinical Research GroupCoral Springs, United States
  • Gulfcoast Clinical Research CenterFort Myers, United States
  • Clinical Neuroscience Solutions IncJacksonville, United States
  • South Florida Research Phase I - IVMiami Springs, United States
  • Behavioral Clinical Research, IncNorth Miami, United States
  • Clinical Neuroscience Solutions IncOrlando, United States
  • University of South FloridaTampa, United States
  • Atlanta Center for Medical Research - CenExel ACMR - PPDSAtlanta, United States
  • iResearch Atlanta - CenExel - PPDSDecatur, United States
  • Psych AtlantaMarietta, United States
  • Accelerated Clinical Trials,LLCPeachtree Corners, United States

And 37 more, listed on the interactive page.

Sources for sites
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Related records

Drugs (2)

Lead sponsors (1)

Conditions (4)

Targets (1)