At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 22 enrolled
Drug / intervention
SEP-363856drug
Likely dose
SEP-363856 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Positron Emission Tomography Study to Investigate the Effect of Adjunctive Administration of SEP-363856 on Brain Dopamine Synthesis Capacity Using 18F-DOPA in Adult Subjects With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 31, 2019·Updated Dec 27, 2024
In Brief
A Phase 1 clinical trial evaluating SEP-363856 for Schizophrenia. Completed, enrolled 22 participants across 1 site.
Detailed Summary
A clinical study to investigate the effect of an investigational drug as an added medication to an antipsychotic, in adults with schizophrenia, as measured positron emission tomography (PET) imaging . This study is accepting male and female participants between 18 years old -45 years old who have been diagnosed with schizophrenia. This study will be conducted in 2 locations in the UK. The study will last approximately 14 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartAug 2019
Primary CompletionJun 2023
TodayJul 2026
First PostedJul 31, 2019
Enrollment StartAug 7, 2019
Primary CompletionJun 6, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.9 years ago
Interventions
SEP-363856drug
SEP-363856 50mg, 75mg flexable dosing, dosed once daily capsule