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

NCT ID NCT06701903

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 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.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 570 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Provide written informed consent before the initiation of any study specific procedures; * At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline: * HAM-A Total score of ≥ 22; * HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2; * CGI-S score of ≥ 4; * History of inadequate response (\< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire \[ATRQ\] for GAD) to at least 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 milligram \[mg\], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms. Exclusion Criteria: * Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: * Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; * Bipolar Disorder; * MADRS total score \> 18 at Screening or Baseline; * In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or * At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit; * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; * At Screening or Baseline MADRS Item 10 score ≥ 5; or * The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator; * Lifetime history of failure to respond to \> 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks)

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed

    RECRUITING

    Torun, 87 100, Poland

  • CalNeuro Research

    RECRUITING

    Los Angeles, California, 90025, United States

  • California Neuroscience Research

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk

    RECRUITING

    Svidník, 08901, Slovakia

  • Centrum Zdrowia Alcea

    RECRUITING

    Gdansk, 80 283, Poland

  • Clinical Center Dr Dragisa Misovic Dedinje

    RECRUITING

    Belgrade, 11000, Serbia

  • Crystal Comfort s.r.o.

    RECRUITING

    Vranov nad Topľou, 093 01, Slovakia

  • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

    RECRUITING

    Sofia, 1408, Bulgaria

  • Excell Research Inc

    RECRUITING

    Oceanside, California, 92056, United States

  • Institute of Mental Health Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • Leading Edge Research

    RECRUITING

    Encino, California, 91316, United States

  • Medical Center Hera EOOD

    RECRUITING

    Sofia, 1510, Bulgaria

  • Medical Center Intermedica, OOD

    RECRUITING

    Sofia, 1680, Bulgaria

  • Medical Center Lifemed

    RECRUITING

    Kardzhali, 6600, Bulgaria

  • Medical Center Medconsult-Pleven

    RECRUITING

    Pleven, 5800, Bulgaria

  • Medical Center Mentalcare OOD

    RECRUITING

    Plovdiv, 4004, Bulgaria

  • Medical Center Sv Dimitar Blagoevgrad

    RECRUITING

    Blagoevgrad, 2700, Bulgaria

  • Medical center - VAS OOD

    RECRUITING

    Targovishte, 7700, Bulgaria

  • Mental Health Center - Rousse

    RECRUITING

    Rousse, 7003, Bulgaria

  • Miami Dade Medical Research Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    RECRUITING

    Leszno, 64-100, Poland

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Pacific Clinical Research Medical Group

    COMPLETED

    Upland, California, 91786, United States

  • Precise Clinical Research, Inc.

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Proscience Research Group

    RECRUITING

    Culver City, California, 90230, United States

  • Prywatne Gabinety Lekarskie PROMEDICUS

    RECRUITING

    Bialystok, 15272, Poland

  • Przychodnia Srodmiescie SP. z o.o.

    RECRUITING

    Bydgoszcz, 85-080, Poland

  • Psychiatricka Ambulancia Mentum S.R.O.

    RECRUITING

    Bratislava, 821 01, Slovakia

  • Psychiatricka Ambulancia Psycholine S.R.O.

    RECRUITING

    Rimavská Sobota, 979 01, Slovakia

  • Relaro Medical Trials

    RECRUITING

    Dallas, Texas, 75243, United States

  • Richmond Behavioral Associates

    RECRUITING

    Staten Island, New York, 10314, United States

  • SPRI Clinical Trials, LLC

    RECRUITING

    Brooklyn, New York, 11235, United States

  • Sarkis Clinical Trials

    COMPLETED

    Gainesville, Florida, 32607, United States

  • Sooner Clinical Research

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

  • Special Neuropsychiatric Hospital Kovin

    RECRUITING

    Kovin, 26220, Serbia

  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

    RECRUITING

    Novi Kneževac, 23330, Serbia

  • Suburban Research Associates

    RECRUITING

    Media, Pennsylvania, 19063, United States

  • Sunwise Clinical Research

    RECRUITING

    Walnut Creek, California, 94596, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center NIS

    RECRUITING

    Niš, 18000, Serbia

  • University Clinical Center of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University Clinical Center of Serbia 1

    RECRUITING

    Belgrade, 11000, Serbia

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Buffalo

    RECRUITING

    Buffalo, New York, 14215, United States

  • University of Connecticut Health Center

    RECRUITING

    Farmington, Connecticut, 06032, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33613, United States

  • Wake Research PRI Encino

    RECRUITING

    Encino, California, 91316, United States

  • Woodland International Research Group

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Woodland Research Northwest

    RECRUITING

    Rogers, Arkansas, 72758, United States

  • iResearch Atlanta LLC

    RECRUITING

    Decatur, Georgia, 30030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.