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NCT06480383From ClinicalTrials.govRecruiting

Study of ITI-1284 as an Adjunctive 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

  • Generalized Anxiety Disorder

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Intra-Cellular Therapies, Inc.
Enrolment target
705
Started
5 August 2024
Main results due
16 March 2027
Study sites
56
Registry updated
25 September 2026

Can you take part?

  • No age limit is stated.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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).

What this study is about

In the sponsor’s own words, from the registry.

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

Study sites(56)

  • Behavioral Research Specialists LLC

    Glendale, California, United States

    Recruiting

  • Sun Valley Research Center

    Imperial, California, United States

    Recruiting

  • Synergy East

    Lemon Grove, California, United States

    Recruiting

  • Excell Research Inc

    Oceanside, California, United States

    Recruiting

  • NRC Research Institute

    Orange, California, United States

    Recruiting

  • Anderson Clinical Research

    Redlands, California, United States

    Recruiting

  • Premier Clinical Research

    Miami, Florida, United States

    Recruiting

  • Global Medical Institutes

    Miami, Florida, United States

    Recruiting

  • Miami Dade Medical Research Institute

    Miami, Florida, United States

    Recruiting

  • Sunshine Medical Solution

    Miami, Florida, United States

    Recruiting

  • South Florida Research Inc

    Miami Springs, Florida, United States

    Recruiting

  • K2 Medical Research

    Tampa, Florida, United States

    Recruiting

  • CenExeli Research LLC

    Atlanta, Georgia, United States

    Recruiting

  • Atlanta Center for Medical Research

    Atlanta, Georgia, United States

    Recruiting

  • Michigan Clinical Research Institute

    Ann Arbor, Michigan, United States

    Recruiting

  • Bio Behavioral Health

    Toms River, New Jersey, United States

    Recruiting

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, United States

    Recruiting

  • Neuro Behavioral Clinical Research

    North Canton, Ohio, United States

    Recruiting

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, United States

    Recruiting

  • Lehigh Center for Clinical Research LLC

    Allentown, Pennsylvania, United States

    Recruiting

  • Suburban Research Associates

    Media, Pennsylvania, United States

    Recruiting

  • Austin Clinical Trial Partners

    Austin, Texas, United States

    Recruiting

  • BioBehavioral Research of Austin PC

    Austin, Texas, United States

    Recruiting

  • Aims Trials LLC

    Plano, Texas, United States

    Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington, United States

    Recruiting

  • Medical Center Sv Dimitar Blagoevgrad

    Blagoevgrad, Bulgaria

    Recruiting

  • Mental Health Center Prof. Dr. Ivan Temkov

    Burgas, Bulgaria

    Recruiting

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

    Pleven, Bulgaria

    Recruiting

  • Medical Center Mentalcare OOD

    Plovdiv, Bulgaria

    Recruiting

  • Mental Health Center - Rousse

    Rousse, Bulgaria

    Recruiting

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

    Sofia, Bulgaria

    Recruiting

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

    Sofia, Bulgaria

    Recruiting

  • Medical Center Hera EOOD

    Sofia, Bulgaria

    Recruiting

  • Medical Center Intermedica, OOD

    Sofia, Bulgaria

    Recruiting

  • Medical center - VAS OOD

    Targovishte, Bulgaria

    Recruiting

  • Diagnostic Consulting Center Mladost - M Varna 1

    Varna, Bulgaria

    Recruiting

  • Diagnostic Consulting Center Mladost - M Varna

    Varna, Bulgaria

    Recruiting

  • Mental Health Center - Vratsa EOOD

    Vratsa, Bulgaria

    Recruiting

  • Medipa S R O

    Brno, Czechia

    Recruiting

  • A Shine S R O

    Pilsen, Czechia

    Recruiting

  • Clintrial s r o

    Prague, Czechia

    Recruiting

  • Medical Services Prague S R O

    Prague, Czechia

    Recruiting

  • Institut Neuropsychiatricke pece

    Prague, Czechia

    Recruiting

  • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

    Bialystok, Poland

    Recruiting

  • Przychodnia Srodmiescie SP. z o.o.

    Bydgoszcz, Poland

    Recruiting

  • Specjalistyczna Praktyka Lekarska Piotr Zalitacz

    Gorlice, Poland

    Recruiting

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    Leszno, Poland

    Recruiting

  • Filip Rybakowski Specjalistyczna Praktyka Lekarska

    Poznan, Poland

    Recruiting

  • Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed

    Torun, Poland

    Recruiting

  • Institute of Mental Health Serbia

    Belgrade, Serbia

    Recruiting

  • University Clinical Center of Serbia 1

    Belgrade, Serbia

    Recruiting

  • University Clinical Center of Serbia

    Belgrade, Serbia

    Recruiting

  • University Clinical Hospital Center Dr Dragisa Misovic- Dedi

    Belgrade, Serbia

    Recruiting

  • Special Neuropsychiatric Hospital Kovin

    Kovin, Serbia

    Recruiting

  • University Clinical Center Kragujevac

    Kragujevac, Serbia

    Recruiting

  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

    Novi Kneževac, Serbia

    Recruiting

Showing 56 of 56 sites. 56 of the 56 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06480383. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder | Trialion