A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients with Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513302-56-00

Acronym

ITI-1284-301

Enrollment

312

Registered

2024-12-11

Start date

2025-11-17

Completion date

Unknown

Last updated

2025-12-17

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

Conditions

Generalized Anxiety Disorder

Brief summary

Primary efficacy endpoint is change from baseline to Week 6 in HAM-A total score.

Detailed description

Key secondary efficacy endpoint is change from baseline to Week 6 in CGI-S score., Additional secondary efficacy endpoints may include by visit: change from baseline in HAM-A total score; CGI-S score; or Q-LES-Q score; ≥ 50% reduction from baseline in HAM-A total score; HAM-A remission (HAM-A total score ≤ 7); CGI-I scale score; change from baseline in MADRS total score; PGI-C scale score

Interventions

DRUGITI-1284

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoint is change from baseline to Week 6 in HAM-A total score.	—

Secondary

Measure	Time frame
Key secondary efficacy endpoint is change from baseline to Week 6 in CGI-S score., Additional secondary efficacy endpoints may include by visit: change from baseline in HAM-A total score; CGI-S score; or Q-LES-Q score; ≥ 50% reduction from baseline in HAM-A total score; HAM-A remission (HAM-A total score ≤ 7); CGI-I scale score; change from baseline in MADRS total score; PGI-C scale score	—

Countries

Bulgaria, Czechia, Finland, Poland

Outcome results

None listed

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