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

NCT06701903 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

  • Generalized Anxiety Disorder

Interventions

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

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Finland
  • Poland
  • Serbia
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06701903 on ClinicalTrials.gov