NCT06701903From ClinicalTrials.govRecruiting

Study of ITI-1284 as Monotherapy 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 Monotherapy Treatment in Patients With Generalized Anxiety Disorder Who Have Had 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: 570
Started: 21 November 2024
Main results due: 14 October 2027
Study sites: 51
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
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:

* 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)

What this study is about

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

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.

Study sites(51)

University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Woodland International Research Group
Little Rock, Arkansas, United States
Recruiting
Woodland Research Northwest
Rogers, Arkansas, United States
Recruiting
Proscience Research Group
Culver City, California, United States
Recruiting
Leading Edge Research
Encino, California, United States
Recruiting
Wake Research PRI Encino
Encino, California, United States
Recruiting
CalNeuro Research
Los Angeles, California, United States
Recruiting
Excell Research Inc
Oceanside, California, United States
Recruiting
California Neuroscience Research
Sherman Oaks, California, United States
Recruiting
Pacific Clinical Research Medical Group
Upland, California, United States
Completed
Sunwise Clinical Research
Walnut Creek, California, United States
Recruiting
University of Connecticut Health Center
Farmington, Connecticut, United States
Recruiting
Sarkis Clinical Trials
Gainesville, Florida, United States
Completed
Miami Dade Medical Research Institute
Miami, Florida, United States
Recruiting
University of South Florida
Tampa, Florida, United States
Recruiting
iResearch Atlanta LLC
Decatur, Georgia, United States
Recruiting
Precise Clinical Research, Inc.
Flowood, Mississippi, United States
Recruiting
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Recruiting
University of Buffalo
Buffalo, New York, United States
Recruiting
Richmond Behavioral Associates
Staten Island, New York, United States
Recruiting
The Ohio State University
Columbus, Ohio, United States
Recruiting
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Recruiting
Suburban Research Associates
Media, Pennsylvania, United States
Recruiting
Relaro Medical Trials
Dallas, Texas, United States
Recruiting
Northwest Clinical Research Center
Bellevue, Washington, United States
Recruiting
Medical Center Sv Dimitar Blagoevgrad
Blagoevgrad, Bulgaria
Recruiting
Medical Center Lifemed
Kardzhali, Bulgaria
Recruiting
Medical Center Medconsult-Pleven
Pleven, Bulgaria
Recruiting
Medical Center Mentalcare OOD
Plovdiv, Bulgaria
Recruiting
Mental Health Center - Rousse
Rousse, 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
Prywatne Gabinety Lekarskie PROMEDICUS
Bialystok, Poland
Recruiting
Przychodnia Srodmiescie SP. z o.o.
Bydgoszcz, Poland
Recruiting
Centrum Zdrowia Alcea
Gdansk, Poland
Recruiting
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, Poland
Recruiting
Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed
Torun, Poland
Recruiting
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, Serbia
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
Special Neuropsychiatric Hospital Kovin
Kovin, Serbia
Recruiting
University Clinical Center Kragujevac
Kragujevac, Serbia
Recruiting
University Clinical Center NIS
Niš, Serbia
Recruiting
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
Novi Kneževac, Serbia
Recruiting
Psychiatricka Ambulancia Mentum S.R.O.
Bratislava, Slovakia
Recruiting
Psychiatricka Ambulancia Psycholine S.R.O.
Rimavská Sobota, Slovakia
Recruiting
Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk
Svidník, Slovakia
Recruiting
Crystal Comfort s.r.o.
Vranov nad Topľou, Slovakia
Recruiting

Showing 51 of 51 sites. 49 of the 51 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 NCT06701903. 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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