Recruiting PHASE2 INTERVENTIONAL 3-arm 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

Sponsor: Intra-Cellular Therapies, Inc.

Conditions Generalized Anxiety Disorder

Interventions ITI-1284 10 mg ITI-1284 20 mg Placebo

Updated 3 times since 2024 Last updated: Jan 7, 2026 Started: Nov 21, 2024 Primary completion: Jun 30, 2027 Completion: Jun 30, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06701903, this PHASE2 trial focuses on Generalized Anxiety Disorder and remains actively recruiting participants. Sponsored by Intra-Cellular Therapies, Inc., it has been updated 3 times since 2024, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

Change History

3 versions recorded

Feb 2026 — Present [monthly]

Recruiting PHASE2
Mar 2025 — Feb 2026 [monthly]

Recruiting PHASE2
Dec 2024 — Mar 2025 [monthly]

Recruiting PHASE2

First recorded

Nov 2024

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Intra-Cellular Therapies, Inc.

Data source: Intra-Cellular Therapies, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Belgrade, Serbia , Bellevue, United States , Bialystok, Poland , Birmingham, United States , Blagoevgrad, Bulgaria , Boston, United States , Bratislava, Slovakia , Brooklyn, United States , Buffalo, United States , Bydgoszcz, Poland and 42 more locations