trial

A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

NCTId NCT05848700
as of 2026-07-01
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at a glance
Phase 1 · Completed
Enrollment 60 (actual)
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion 2024-03-15
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 1
Status
Completed
Enrollment
60 (actual)
Study type
Interventional
Allocation
Randomized
Model
Parallel
Masking
Quadruple
Start
2023-06-21
Primary completion
2024-03-15
Eligibility
ALL · 18 Years · 65 Years

Interventions & indications

Drugs
Ulotaront

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

Sites

7 total
Little Rock, United StatesRogers, United StatesMiami Lakes, United StatesOakland Park, United StatesAtlanta, United StatesNorth Canton, United StatesRichardson, United States

Facts & assertions

4 sourced
Enrollment
60
Phase
PHASE1
Primary Completion Date
2024-03-15
Status
COMPLETED
relationships
The graph out of here
drug
Ulotaront
drug
lead_sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
company
indication
Schizophrenia
indication
Schizophrenia
indication