NCT06701903

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 570 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.

Detailed description

The study will be conducted in 3 periods: * Screening Period (up to 2 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur; * Double-blind Treatment Period (6 weeks) during which a total of approximately 570 patients are planned to be randomized in a 1:1:1 ratio to receive one of the 3 treatments (ITI-1284 10 mg, ITI-1284 20 mg, or placebo); * Safety Follow-up Period (1 week) during which all patients will return for a safety follow-up visit approximately 1 week after the last dose of study drug.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	ITI-1284 10 mg	ITI-1284 10 mg tablet, taken once daily, sublingual administration.
DRUG	ITI-1284 20 mg	ITI-1284 20 mg tablet, taken once daily, sublingual administration.
DRUG	Placebo	Matching placebo tablet, taken once daily, sublingual administration

Timeline

• Start date: 2024-11-21
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-11-22
• Last updated: 2026-01-09

Locations

60 sites across 6 countries: United States, Bulgaria, Finland, Poland, Serbia, Slovakia

Regulatory

• FDA-regulated drug study