Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

August 27, 2026 updated by: Intra-Cellular Therapies, Inc.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in 3 periods:

  • Screening Period (up to 2 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur;
  • Double-blind Treatment Period (6 weeks) during which a total of approximately 570 patients are planned to be randomized in a 1:1:1 ratio to receive one of the 3 treatments (ITI-1284 10 mg, ITI-1284 20 mg, or placebo);
  • Safety Follow-up Period (1 week) during which all patients will return for a safety follow-up visit approximately 1 week after the last dose of study drug.

Study Type

Interventional

Enrollment (Estimated)

570

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Recruiting
        • Medical Center Sv Dimitar Blagoevgrad
      • Kardzhali, Bulgaria, 6600
        • Recruiting
        • Medical Center Lifemed
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Medical Center Medconsult-Pleven
      • Plovdiv, Bulgaria, 4004
        • Recruiting
        • Medical Center Mentalcare OOD
      • Rousse, Bulgaria, 7003
        • Recruiting
        • Mental Health Center - Rousse
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Medical Center Intermedica, OOD
      • Sofia, Bulgaria, 1408
        • Recruiting
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Medical Center Hera EOOD
      • Targovishte, Bulgaria, 7700
        • Recruiting
        • Medical center - VAS OOD
  • Poland
      • Bialystok, Poland, 15272
        • Recruiting
        • Prywatne Gabinety Lekarskie PROMEDICUS
      • Bydgoszcz, Poland, 85-080
        • Recruiting
        • Przychodnia Srodmiescie SP. z o.o.
      • Gdansk, Poland, 80 283
        • Recruiting
        • Centrum Zdrowia Alcea
      • Leszno, Poland, 64-100
        • Recruiting
        • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
      • Torun, Poland, 87 100
        • Recruiting
        • Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute of Mental Health Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Center Dr Dragisa Misovic Dedinje
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia 1
      • Kovin, Serbia, 26220
        • Recruiting
        • Special Neuropsychiatric Hospital Kovin
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac
      • Niš, Serbia, 18000
        • Recruiting
        • University Clinical Center Nis
      • Novi Kneževac, Serbia, 23330
        • Recruiting
        • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
  • Slovakia
      • Bratislava, Slovakia, 821 01
        • Recruiting
        • Psychiatricka Ambulancia Mentum S.R.O.
      • Rimavská Sobota, Slovakia, 979 01
        • Recruiting
        • Psychiatricka Ambulancia Psycholine S.R.O.
      • Svidník, Slovakia, 08901
        • Recruiting
        • Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk
      • Vranov nad Topľou, Slovakia, 093 01
        • Recruiting
        • Crystal Comfort s.r.o.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Woodland International Research Group
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Woodland Research Northwest
    • California
      • Culver City, California, United States, 90230
        • Recruiting
        • ProScience Research Group
      • Encino, California, United States, 91316
        • Recruiting
        • Wake Research PRI Encino
      • Encino, California, United States, 91316
        • Recruiting
        • Leading Edge Research
      • Los Angeles, California, United States, 90025
        • Recruiting
        • CalNeuro Research
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research Inc
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • California Neuroscience Research
      • Upland, California, United States, 91786
        • Completed
        • Pacific Clinical Research Medical Group
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Sunwise Clinical Research
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Recruiting
        • University of Connecticut Health Center
    • Florida
      • Gainesville, Florida, United States, 32607
        • Completed
        • Sarkis Clinical Trials
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Dade Medical Research Institute
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • iResearch Atlanta LLC
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Precise Clinical Research, Inc.
    • New York
      • Brooklyn, New York, United States, 11235
        • Recruiting
        • SPRI Clinical Trials, LLC
      • Buffalo, New York, United States, 14215
        • Recruiting
        • University of Buffalo
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Richmond Behavioral Associates
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Recruiting
        • Sooner Clinical Research
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Suburban Research Associates
    • Texas
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Relaro Medical Trials
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ITI-1284 10mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
Drug: ITI-1284 10 mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
Experimental: ITI-1284 20mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Drug: ITI-1284 20 mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Placebo Comparator: Placebo
Matching placebo tablet, taken once daily, sublingual administration
Drug: Placebo
Matching placebo tablet, taken once daily, sublingual administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Week 6
The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It is comprised of 14 items that are rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 with a higher score indicating increased severity of anxiety symptoms.
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression Scale-Severity (CGI-S)
Time Frame: Week 6
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Investigators

  • Study Director: Intra-Cellular Therapies,Inc. Clinical Trial, Intra-Cellular Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Estimated)

October 14, 2027

Study Completion (Estimated)

July 20, 2028

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-1284-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe