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NCT05542264 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT05542264: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT05542264 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05542264, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia, and assess wether it affectsbody-weight associated parameters. This study is accepting male and female participants age 18 years to 65 years. This study will be conducted in approximately 6 study sites in the United States. Participation could last up to 13 weeks.
Interventions
- DRUG SEP-363856
- DRUG Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-11-15 |
| Est. Completion | 2024-02-12 |
| Phase | Phase 1 |
What the finished NCT05542264 record still lists
NCT05542264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which SEP-363856 is the first listed.
NCT05542264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05542264 about?
NCT05542264 is a clinical study titled "A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia". A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia, and assess wether it affectsbody-weight associated parameters. This study is accepting male and female participants age 18 years to 65 years. This study will be co...
What is the current status of trial NCT05542264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2022-11-15. Estimated completion is 2024-02-12.
What interventions are being tested in trial NCT05542264?
The interventions under investigation include: SEP-363856 (DRUG), Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) (DRUG).
Who is sponsoring clinical trial NCT05542264?
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 NCT05542264's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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