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

January 7, 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 an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an 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
        • Clinical Site
      • Kardzhali, Bulgaria, 6600
        • Recruiting
        • Clinical Site
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Clinical Site
      • Plovdiv, Bulgaria, 4004
        • Recruiting
        • Clinical Site
      • Rousse, Bulgaria, 7003
        • Recruiting
        • Clinical Site
      • Sofia, Bulgaria, 1408
        • Recruiting
        • Clinical Site
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Clinical Site
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Clinical Site
      • Targovishte, Bulgaria, 7700
        • Recruiting
        • Clinical Site
  • Finland
      • Helsinki, Finland, 00100
        • Not yet recruiting
        • Clinical Site
      • Kuopio, Finland, 70110
        • Not yet recruiting
        • Clinical Site
      • Oulu, Finland, 90100
        • Not yet recruiting
        • Clinical Site
      • Tampere, Finland, 33210
        • Not yet recruiting
        • Clinical Site
  • Poland
      • Bialystok, Poland, 15272
        • Recruiting
        • Clinical Site
      • Bydgoszcz, Poland, 85-080
        • Recruiting
        • Clinical Site
      • Gdansk, Poland, 80283
        • Recruiting
        • Clinical Site
      • Leszno, Poland, 64100
        • Recruiting
        • Clinical Site
      • Torun, Poland, 87100
        • Recruiting
        • Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site_2
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site_3
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site_4
      • Kovin, Serbia, 26220
        • Recruiting
        • Clinical Site
      • Kragujevac, Serbia, 34000
        • Recruiting
        • Clinical Site
      • Niš, Serbia, 18000
        • Recruiting
        • Clinical Site
      • Novi Kneževac, Serbia, 23330
        • Recruiting
        • Clinical Site
  • Slovakia
      • Bratislava, Slovakia, 82101
        • Recruiting
        • Clinical Site
      • Rimavská Sobota, Slovakia, 97901
        • Recruiting
        • Clinical Site
      • Svidník, Slovakia, 08901
        • Recruiting
        • Clinical Site
      • Vranov nad Topľou, Slovakia, 09301
        • Recruiting
        • Clinical Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Clinical Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Clinical Site
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Clinical Site
    • California
      • Culver City, California, United States, 90230
        • Recruiting
        • Clinical Site
      • Encino, California, United States, 91316
        • Recruiting
        • Clinical Site
      • Encino, California, United States, 91316
        • Recruiting
        • Clinical Site_2
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Clinical Site
      • Oceanside, California, United States, 92056
        • Recruiting
        • Clinical Site
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • Clinical Site
      • Upland, California, United States, 91786
        • Active, not recruiting
        • Clinical Site
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Clinical Site
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • Clinical Site
    • Florida
      • Gainesville, Florida, United States, 32607
        • Active, not recruiting
        • Clinical Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Clinical Site
      • Orlando, Florida, United States, 32803
        • Active, not recruiting
        • Cinical Site
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Clinical Site
      • Tampa, Florida, United States, 33613
        • Not yet recruiting
        • Clinical Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Active, not recruiting
        • Clinical Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Clinical Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Recruiting
        • Clinical Site
      • Buffalo, New York, United States, 14215
        • Active, not recruiting
        • Clinical Site
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Clinical Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Recruiting
        • Clinical Site
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Clinical Site
    • Texas
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Clinical Site
      • Dallas, Texas, United States, 75231
        • Not yet recruiting
        • Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Clinical Site

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 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 (at least the minimum GAD-approved dose per package insert) 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 (ie, at least the minimum dose approved for GAD per package insert) 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
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.

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)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

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)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 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.

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