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 Jan 10, 2026 · Last updated Jun 22, 2026 · Updated 31 times

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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Cinical Site
ACTIVE_NOT_RECRUITING

Orlando, Florida, 32803, United States
Clinical Site
RECRUITING

Birmingham, Alabama, 35294, United States
Clinical Site
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Little Rock, Arkansas, 72211, United States
Clinical Site
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Rogers, Arkansas, 72758, United States
Clinical Site
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Culver City, California, 90230, United States
Clinical Site
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Encino, California, 91316, United States
Clinical Site
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Los Angeles, California, 90025, United States
Clinical Site
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Oceanside, California, 92056, United States
Clinical Site
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Sherman Oaks, California, 91403, United States
Clinical Site
ACTIVE_NOT_RECRUITING

Upland, California, 91786, United States
Clinical Site
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Walnut Creek, California, 94596, United States
Clinical Site
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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
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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
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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
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Blagoevgrad, 2700, Bulgaria
Clinical Site
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Kardzhali, 6600, Bulgaria
Clinical Site
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Pleven, 5800, Bulgaria
Clinical Site
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Plovdiv, 4004, Bulgaria
Clinical Site
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Rousse, 7003, Bulgaria
Clinical Site
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Sofia, 1408, Bulgaria
Clinical Site
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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
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Bydgoszcz, 85-080, Poland
Clinical Site
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Gdansk, 80283, Poland
Clinical Site
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Leszno, 64100, Poland
Clinical Site
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Torun, 87100, Poland
Clinical Site
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Belgrade, 11000, Serbia
Clinical Site
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Kovin, 26220, Serbia
Clinical Site
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Kragujevac, 34000, Serbia
Clinical Site
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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

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.

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 GENERALIZED ANXIETY DISORDER