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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516684-82-00
Acronym
ITI-1284-302
Enrollment
349
Registered
2025-06-02
Start date
2025-07-21
Completion date
Unknown
Last updated
2025-11-19

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

The primary efficacy endpoint is the change from baseline to end of Week 6 in HAM-A total score.

Detailed description

The key secondary efficacy endpoint is the change from baseline to end of Week 6 in CGI-S score., Additional secondary efficacy endpoints include by visit, change from baseline in HAM-A total score; CGI-S score; 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

Sponsors

Intra-Cellular Therapies Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint is the change from baseline to end of Week 6 in HAM-A total score.—

Secondary

MeasureTime frame
The key secondary efficacy endpoint is the change from baseline to end of Week 6 in CGI-S score., Additional secondary efficacy endpoints include by visit, change from baseline in HAM-A total score; CGI-S score; 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, Slovakia

Outcome results

None listed

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