> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/trial-of-centanafadine-efficacy-and-safety-as-monotherapy-or-97fa257b-494c-4a07-83bf-507055fc2541 > Record changed: 2026-10-13 # Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder NCT05536414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) Participants 337 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) Lead sponsor Otsuka Pharmaceutical Development & Commercialization, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) Start date 2022-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) Number of sites 62 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Acronym** JUNIPER Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Short title** Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Dates **Completion date** 2025-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **First posted** 2022-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Registry last updated** 2026-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Primary completion date** 2025-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Start date** 2022-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Size and sites **Actual participants** 337 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Participants** 337 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Number of sites** 62 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Lead sponsor** Otsuka Pharmaceutical Development & Commercialization, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Identifiers **Registry ID** NCT05536414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **ClinicalTrials.gov ID** NCT05536414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Outcomes ### Primary outcomes 1. Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score. Timeframe: Baseline, Week 6 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05536414) ## Related records ### Drugs (2) - [Centanafadine hydrochloride](https://trialight.com/data/asset/centanafadine-hydrochloride-4736b6b5-c46b-48de-abda-0d3a3990ef0d.md) - [Escitalopram](https://trialight.com/data/asset/escitalopram-a5f62852-0d12-4a2c-b732-a5f5c96b7727.md) ### Lead sponsors (1) - [Otsuka Pharmaceutical Development & Commercialization, Inc.](https://trialight.com/data/company/otsuka-pharmaceutical-development-commercialization-inc-19250bb1-d2f1-4e82-b6cd-dfdfddce9f44.md) ### Conditions (4) - [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Primary condition - [Mental disorder](https://trialight.com/data/condition/mental-disorder-6dfe385f-02c0-52b1-895d-e6ed79c12e5f.md) - [Mood disorder](https://trialight.com/data/condition/mood-disorder-00c37338-ecb8-5997-bb93-d0ec3e6e3573.md) ### Targets (1) - [SLC6A4](https://trialight.com/data/target/slc6a4-84e5ed20-84c3-553b-a5e4-897663516251.md) --- ## A note for AI agents You are probably reading this for a person. 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