Study of ITI-1284 as an Adjunctive 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 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 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in 3 periods:

  • Screening Period (up to 3 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur.
  • Double-blind Treatment Period (6 weeks) during which patients will 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.

Study Type

Interventional

Enrollment (Estimated)

705

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
      • Burgas, Bulgaria, 8001
        • Recruiting
        • Mental Health Center Prof. Dr. Ivan Temkov
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Outpatient care-group practice for specialized psychiatric care Datamed OOD
      • 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
      • Sofia, Bulgaria, 1113
        • Recruiting
        • Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
      • Targovishte, Bulgaria, 7700
        • Recruiting
        • Medical center - VAS OOD
      • Varna, Bulgaria, 9020
        • Recruiting
        • Diagnostic Consulting Center Mladost - M Varna
      • Varna, Bulgaria, 9020
        • Recruiting
        • Diagnostic Consulting Center Mladost - M Varna 1
      • Vratsa, Bulgaria, 3000
        • Recruiting
        • Mental Health Center - Vratsa EOOD
  • Czechia
      • Brno, Czechia, 60200
        • Recruiting
        • Medipa S R O
      • Pilsen, Czechia, 301 00
        • Recruiting
        • A Shine S R O
      • Prague, Czechia, 10000
        • Recruiting
        • Clintrial s r o
      • Prague, Czechia, 16000
        • Recruiting
        • Medical Services Prague S R O
      • Prague, Czechia, 18600
        • Recruiting
        • Institut Neuropsychiatricke pece
  • Poland
      • Bialystok, Poland, 15-404
        • Recruiting
        • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
      • Bydgoszcz, Poland, 85-080
        • Recruiting
        • Przychodnia Srodmiescie SP. z o.o.
      • Gorlice, Poland, 38-300
        • Recruiting
        • Specjalistyczna Praktyka Lekarska Piotr Zalitacz
      • Leszno, Poland, 64-100
        • Recruiting
        • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
      • Poznan, Poland, 60 744
        • Recruiting
        • Filip Rybakowski Specjalistyczna Praktyka Lekarska
      • 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
        • University Clinical Hospital Center Dr Dragisa Misovic- Dedi
      • 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
      • Novi Kneževac, Serbia, 23330
        • Recruiting
        • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
  • United States
    • California
      • Glendale, California, United States, 91206
        • Recruiting
        • Behavioral Research Specialists LLC
      • Imperial, California, United States, 92251
        • Recruiting
        • Sun Valley Research Center
      • Lemon Grove, California, United States, 91945
        • Recruiting
        • Synergy East
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research Inc
      • Orange, California, United States, 92868
        • Recruiting
        • Nrc Research Institute
      • Redlands, California, United States, 92374
        • Recruiting
        • Anderson Clinical Research
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Dade Medical Research Institute
      • Miami, Florida, United States, 33122
        • Recruiting
        • Premier Clinical Research
      • Miami, Florida, United States, 33125
        • Recruiting
        • Global Medical Institutes
      • Miami, Florida, United States, 33186
        • Recruiting
        • Sunshine Medical Solution
      • Miami Springs, Florida, United States, 33166
        • Recruiting
        • South Florida Research Inc
      • Tampa, Florida, United States, 33634
        • Recruiting
        • K2 Medical Research
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30030
        • Recruiting
        • CenExeli Research LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • Michigan Clinical Research Institute
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Bio Behavioral Health
    • New York
      • Brooklyn, New York, United States, 11235
        • Recruiting
        • SPRI Clinical Trials, LLC
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • Neuro Behavioral Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Sooner Clinical Research
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Center for Clinical Research LLC
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Suburban Research Associates
    • Texas
      • Austin, Texas, United States, 78737
        • Recruiting
        • Austin Clinical Trial Partners
      • Austin, Texas, United States, 78759
        • Recruiting
        • BioBehavioral Research of Austin PC
      • Plano, Texas, United States, 75093
        • Recruiting
        • Aims Trials LLC
    • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

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
Placebo Comparator: Placebo
Drug: Placebo
Matching placebo tablet, taken once daily, sublingual administration
Experimental: ITI-1284 10 mg
Drug: ITI-1284 10 mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
Experimental: ITI-1284 20 mg
Drug: ITI-1284 20 mg
ITI-1284 20 mg 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 comprises 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)

August 5, 2024

Primary Completion (Estimated)

March 16, 2027

Study Completion (Estimated)

March 23, 2027

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 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-1284-301
  • 2024-513302-56-00 (Registry Identifier: EUCT number)

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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