Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05628103 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT05628103: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT05628103 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05628103, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study Summary
This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.
Primary Outcome
Discontinuation for clinical reasons was defined as reasons due to adverse event (AE) or lack of efficacy. AEs are defined as untoward medical occurrences that started at the same time of or after the first dose of study drug. The percentage of participants who discontinued for clinical reasons was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to clinical reasons as the numerator divided by the number of participants in the safety
Interventions
- DRUG SEP-363856
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2022-12-19 |
| Est. Completion | 2024-04-01 |
| Phase | Phase 3 |
What the finished NCT05628103 record still lists
NCT05628103 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which SEP-363856 is the first listed.
NCT05628103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05628103 about?
NCT05628103 is a clinical study titled "A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication". This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.
What is the current status of trial NCT05628103?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2022-12-19. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT05628103?
The interventions under investigation include: SEP-363856 (DRUG).
Who is sponsoring clinical trial NCT05628103?
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 NCT05628103's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04033497 · 101 participants · NA
Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases
- NCT05111574 · 101 participants · Phase 2
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
- NCT05984680 · 101 participants
COPD Care Pathway Among Patients With Cancer
- NCT06266299 · 101 participants · Phase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI