A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Patients with Schizophrenia, Followed by an Open-label Extension Phase

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503006-20-00

Acronym

DA801201

Enrollment

Registered

2023-08-11

Start date

Unknown

Completion date

2023-10-02

Last updated

2023-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acutely Psychotic Patients with Schizophrenia

Brief summary

Primary Efficacy Endpoint: Change from Baseline in PANSS total score at Week 6

Detailed description

Efficacy Endpoint: Secondary Efficacy Endpoint: Change from Baseline in CGI-S score at Week 6

Interventions

DRUGSEP-363856

DRUGSEP-363856 matching placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Endpoint: Change from Baseline in PANSS total score at Week 6	—

Secondary

Measure	Time frame
Efficacy Endpoint: Secondary Efficacy Endpoint: Change from Baseline in CGI-S score at Week 6	—

Countries

Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026