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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 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 337 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05536414
The ClinicalTrials.gov registry entry for NCT05536414 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 337 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05536414 reports 0 study locations.
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.
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