Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill may ease anxiety when current meds fall short

NCT ID NCT06480383

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an experimental drug called ITI-1284 for people with generalized anxiety disorder (GAD) whose current treatment isn't working well enough. About 705 adults will receive either ITI-1284 or a placebo added to their usual therapy. The goal is to see if the drug safely reduces anxiety symptoms better than placebo.

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 705 people

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

Started

Aug 2024

Expected to finish

Mar 2027

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Provide written informed consent before the initiation of any study specific procedures; 2. Male or female patients ≥ 18 years of age; 3. 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: 1. HAM-A Total score of ≥ 22; 2. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2; 3. CGI-S score of ≥ 4; 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 1 GAD-approved treatment (ie, one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 milligrams \[mg\], venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms; 5. Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study. NOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure. Exclusion Criteria: 1. Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: 1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; 2. Bipolar Disorder; 2. MADRS total score \> 18 at Screening or Baseline; 3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or 1. 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; 2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; 3. At Screening or Baseline MADRS Item 10 score ≥ 5; or 4. The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator. 4. 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 (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Generalized anxiety disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

    56 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

  • A Shine S R O

    RECRUITING

    Pilsen, 301 00, Czechia

  • Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed

    RECRUITING

    Torun, 87 100, Poland

  • Aims Trials LLC

    RECRUITING

    Plano, Texas, 75093, United States

  • Anderson Clinical Research

    RECRUITING

    Redlands, California, 92374, United States

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Austin Clinical Trial Partners

    RECRUITING

    Austin, Texas, 78737, United States

  • Behavioral Research Specialists LLC

    RECRUITING

    Glendale, California, 91206, United States

  • Bio Behavioral Health

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • BioBehavioral Research of Austin PC

    RECRUITING

    Austin, Texas, 78759, United States

  • CenExeli Research LLC

    RECRUITING

    Atlanta, Georgia, 30030, United States

  • Clintrial s r o

    RECRUITING

    Prague, 10000, Czechia

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

    RECRUITING

    Sofia, 1408, Bulgaria

  • Diagnostic Consulting Center Mladost - M Varna

    RECRUITING

    Varna, 9020, Bulgaria

  • Diagnostic Consulting Center Mladost - M Varna 1

    RECRUITING

    Varna, 9020, Bulgaria

  • Excell Research Inc

    RECRUITING

    Oceanside, California, 92056, United States

  • Filip Rybakowski Specjalistyczna Praktyka Lekarska

    RECRUITING

    Poznan, 60 744, Poland

  • Global Medical Institutes

    RECRUITING

    Miami, Florida, 33125, United States

  • Institut Neuropsychiatricke pece

    RECRUITING

    Prague, 18600, Czechia

  • Institute of Mental Health Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • K2 Medical Research

    RECRUITING

    Tampa, Florida, 33634, United States

  • Lehigh Center for Clinical Research LLC

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Medical Center Hera EOOD

    RECRUITING

    Sofia, 1510, Bulgaria

  • Medical Center Intermedica, OOD

    RECRUITING

    Sofia, 1680, Bulgaria

  • Medical Center Mentalcare OOD

    RECRUITING

    Plovdiv, 4004, Bulgaria

  • Medical Center Sv Dimitar Blagoevgrad

    RECRUITING

    Blagoevgrad, 2700, Bulgaria

  • Medical Services Prague S R O

    RECRUITING

    Prague, 16000, Czechia

  • Medical center - VAS OOD

    RECRUITING

    Targovishte, 7700, Bulgaria

  • Medipa S R O

    RECRUITING

    Brno, 60200, Czechia

  • Mental Health Center - Rousse

    RECRUITING

    Rousse, 7003, Bulgaria

  • Mental Health Center - Vratsa EOOD

    RECRUITING

    Vratsa, 3000, Bulgaria

  • Mental Health Center Prof. Dr. Ivan Temkov

    RECRUITING

    Burgas, 8001, Bulgaria

  • Miami Dade Medical Research Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Michigan Clinical Research Institute

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

    RECRUITING

    Bialystok, 15-404, Poland

  • Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

    RECRUITING

    Sofia, 1113, Bulgaria

  • NRC Research Institute

    RECRUITING

    Orange, California, 92868, United States

  • Neuro Behavioral Clinical Research

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    RECRUITING

    Leszno, 64-100, Poland

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Outpatient care-group practice for specialized psychiatric care Datamed OOD

    RECRUITING

    Pleven, 5800, Bulgaria

  • Premier Clinical Research

    RECRUITING

    Miami, Florida, 33122, United States

  • Przychodnia Srodmiescie SP. z o.o.

    RECRUITING

    Bydgoszcz, 85-080, Poland

  • SPRI Clinical Trials, LLC

    RECRUITING

    Brooklyn, New York, 11235, United States

  • Sooner Clinical Research

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • South Florida Research Inc

    RECRUITING

    Miami Springs, Florida, 33166, United States

  • Special Neuropsychiatric Hospital Kovin

    RECRUITING

    Kovin, 26220, Serbia

  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

    RECRUITING

    Novi Kneževac, 23330, Serbia

  • Specjalistyczna Praktyka Lekarska Piotr Zalitacz

    RECRUITING

    Gorlice, 38-300, Poland

  • Suburban Research Associates

    RECRUITING

    Media, Pennsylvania, 19063, United States

  • Sun Valley Research Center

    RECRUITING

    Imperial, California, 92251, United States

  • Sunshine Medical Solution

    RECRUITING

    Miami, Florida, 33186, United States

  • Synergy East

    RECRUITING

    Lemon Grove, California, 91945, United States

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University Clinical Center of Serbia 1

    RECRUITING

    Belgrade, 11000, Serbia

  • University Clinical Hospital Center Dr Dragisa Misovic- Dedi

    RECRUITING

    Belgrade, 11000, Serbia

More trials for these conditions

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