A Phase 2/3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in the Treatment of Adults with Generalized Anxiety Disorder

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502077-42-00

Acronym

SEP361-226

Enrollment

255

Registered

2023-07-24

Start date

2023-09-14

Completion date

2025-09-17

Last updated

2025-08-29

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

Conditions

generalised anxiety disorder

Brief summary

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint.

Detailed description

Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint.

Interventions

DRUGUlotaront

DRUGPlacebo SEP-365856

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint.	—

Secondary

Measure	Time frame
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint.	—

Countries

Bulgaria, Estonia, Finland, Slovakia, Spain, Sweden

Outcome results

None listed

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