A Phase 2 interventional study of Centanafadine and Escitalopram in Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 62 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's enrollment of 337 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 295 studies on the registry; 18 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Centanafadine · Drug: Placebo
Drug: Centanafadine · Drug: Escitalopram
Drug: Escitalopram · Drug: Placebo
Drug: Placebo
capsule
capsule
capsule
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
Time frame: Baseline, Week 6
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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/
Data sharing details ↗ · clinical-trials.otsuka.com
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in May 2025, 32 months.
Of 96 industry-sponsored phase 2 interventional studies under Depressive Disorder, Major, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 23. This study's 32 months is above that.
Counting every sponsor, half of 195 studies reached it within 22 months; a quarter within 14 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Centanafadine · Escitalopram
Otsuka Pharmaceutical Development & Commercialization, Inc. →