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NCT05536414 · ClinicalTrials.gov registry record · Phase 2
Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 337
- Enrollment target
NCT05536414: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT05536414 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 337 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (153% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05536414, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 337 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Escitalopram
- DRUG Centanafadine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 337 participants |
| Start Date | 2022-09-12 |
| Est. Completion | 2025-05-16 |
| Phase | Phase 2 |
What the finished NCT05536414 record still lists
NCT05536414 is an interventional study that assigns participants to a tested intervention. The registered 337 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (153% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05536414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05536414 about?
NCT05536414 is a clinical study titled "Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder". 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 t...
What is the current status of trial NCT05536414?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 337 participants. The study started on 2022-09-12. Estimated completion is 2025-05-16.
What interventions are being tested in trial NCT05536414?
The interventions under investigation include: Placebo (DRUG), Escitalopram (DRUG), Centanafadine (DRUG).
Who is sponsoring clinical trial NCT05536414?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05536414's enrollment target sits among peer trials
337 141st of 2000 higher than 1,860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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