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
NCT: NCT05536414 ·
Status: COMPLETED ·
Phase: Phase 2
· Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
· Started: 2022-09-12
· Est. Completion: 2025-05-16
Official 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.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 337 participants
Interventions
- DRUG: Centanafadine — capsule
- DRUG: Escitalopram — capsule
- DRUG: Placebo — capsule
Primary Outcomes
- Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score. (Baseline, Week 6)
Trial Locations
- Yuma CNS Research, Yuma, Arizona, United States
- SanRo Clinical Research Group LLC, Bryant, Arkansas, United States
- Behavioral Research Specialists-California-Irvine, Glendale, California, United States
- Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS, Lafayette, California, United States
- OM Research LLC - Lancaster - ClinEdge - PPDS, Lancaster, California, United States
- Synergy Research Centers - SRC - ERG - PPDS, Lemon Grove, California, United States
- ATP Clinical Research, Orange, California, United States
- NRC Research Institute - Orange - PPDS, Orange, California, United States
- Prospective Research Innovations, Rancho Cucamonga, California, United States
- Anderson Clinical Research - ClinEdge - PPDS, Redlands, California, United States
- ...and 10 more locations
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.