New anxiety drug candidate ITI-1284 enters Mid-Stage trial

NCT ID NCT06701903

Recruiting now Symptom relief Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily tablet called ITI-1284, taken under the tongue, can help people with generalized anxiety disorder whose current treatments aren't working well enough. About 570 adults will receive either the drug or a placebo, and researchers will measure changes in anxiety symptoms over time. The trial is double-blind, meaning neither participants nor doctors know who gets the real drug.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ITI-1284 (a tablet taken under the tongue once daily)
What this could lead to: If successful, this could offer a new option for people with generalized anxiety disorder who don't get enough relief from existing treatments.
What could go wrong: This is an early Phase 2 trial, so results are uncertain. The drug may not work better than placebo, and side effects are still being studied.

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Conditions

The condition(s) this trial relates to.

generalized anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GENERALIZED ANXIETY DISORDER

Contacts and locations

Locations

Cinical Site
ACTIVE_NOT_RECRUITING

Orlando, Florida, 32803, United States
Clinical Site
RECRUITING

Birmingham, Alabama, 35294, United States
Clinical Site
RECRUITING

Little Rock, Arkansas, 72211, United States
Clinical Site
RECRUITING

Rogers, Arkansas, 72758, United States
Clinical Site
RECRUITING

Culver City, California, 90230, United States
Clinical Site
RECRUITING

Encino, California, 91316, United States
Clinical Site
RECRUITING

Los Angeles, California, 90025, United States
Clinical Site
RECRUITING

Oceanside, California, 92056, United States
Clinical Site
RECRUITING

Sherman Oaks, California, 91403, United States
Clinical Site
ACTIVE_NOT_RECRUITING

Upland, California, 91786, United States
Clinical Site
RECRUITING

Walnut Creek, California, 94596, United States
Clinical Site
RECRUITING

Farmington, Connecticut, 06030, United States
Clinical Site
ACTIVE_NOT_RECRUITING

Gainesville, Florida, 32607, United States
Clinical Site
RECRUITING

Miami, Florida, 33176, United States
Clinical Site
NOT_YET_RECRUITING

Tampa, Florida, 33612, United States
Clinical Site
NOT_YET_RECRUITING

Tampa, Florida, 33613, United States
Clinical Site
RECRUITING

Decatur, Georgia, 30030, United States
Clinical Site
NOT_YET_RECRUITING

Chicago, Illinois, 60611, United States
Clinical Site
ACTIVE_NOT_RECRUITING

Boston, Massachusetts, 02131, United States
Clinical Site
RECRUITING

Flowood, Mississippi, 39232, United States
Clinical Site
RECRUITING

Brooklyn, New York, 11235, United States
Clinical Site
ACTIVE_NOT_RECRUITING

Buffalo, New York, 14215, United States
Clinical Site
RECRUITING

Staten Island, New York, 10314, United States
Clinical Site
NOT_YET_RECRUITING

Columbus, Ohio, 43210, United States
Clinical Site
RECRUITING

Oklahoma City, Oklahoma, 73116, United States
Clinical Site
RECRUITING

Media, Pennsylvania, 19063, United States
Clinical Site
NOT_YET_RECRUITING

Dallas, Texas, 75231, United States
Clinical Site
RECRUITING

Dallas, Texas, 75243, United States
Clinical Site
RECRUITING

Bellevue, Washington, 98007, United States
Clinical Site
RECRUITING

Blagoevgrad, 2700, Bulgaria
Clinical Site
RECRUITING

Kardzhali, 6600, Bulgaria
Clinical Site
RECRUITING

Pleven, 5800, Bulgaria
Clinical Site
RECRUITING

Plovdiv, 4004, Bulgaria
Clinical Site
RECRUITING

Rousse, 7003, Bulgaria
Clinical Site
RECRUITING

Sofia, 1408, Bulgaria
Clinical Site
RECRUITING

Sofia, 1510, Bulgaria
Clinical Site
RECRUITING

Sofia, 1680, Bulgaria
Clinical Site
RECRUITING

Targovishte, 7700, Bulgaria
Clinical Site
NOT_YET_RECRUITING

Helsinki, 00100, Finland
Clinical Site
NOT_YET_RECRUITING

Kuopio, 70110, Finland
Clinical Site
NOT_YET_RECRUITING

Oulu, 90100, Finland
Clinical Site
NOT_YET_RECRUITING

Tampere, 33210, Finland
Clinical Site
RECRUITING

Bialystok, 15272, Poland
Clinical Site
RECRUITING

Bydgoszcz, 85-080, Poland
Clinical Site
RECRUITING

Gdansk, 80283, Poland
Clinical Site
RECRUITING

Leszno, 64100, Poland
Clinical Site
RECRUITING

Torun, 87100, Poland
Clinical Site
RECRUITING

Belgrade, 11000, Serbia
Clinical Site
RECRUITING

Kovin, 26220, Serbia
Clinical Site
RECRUITING

Kragujevac, 34000, Serbia
Clinical Site
RECRUITING

Niš, 18000, Serbia
Clinical Site
RECRUITING

Novi Kneževac, 23330, Serbia
Clinical Site
RECRUITING

Bratislava, 82101, Slovakia
Clinical Site
RECRUITING

Rimavská Sobota, 97901, Slovakia
Clinical Site
RECRUITING

Svidník, 08901, Slovakia
Clinical Site
RECRUITING

Vranov nad Topľou, 09301, Slovakia
Clinical Site_2
RECRUITING

Encino, California, 91316, United States
Clinical Site_2
RECRUITING

Belgrade, 11000, Serbia
Clinical Site_3
RECRUITING

Belgrade, 11000, Serbia
Clinical Site_4
RECRUITING

Belgrade, 11000, Serbia

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