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

NCT06480383 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: ITI-1284-3012024-513302-56-00
• Study Type: interventional
• Target: 705
• Locations: 5 countries
• Sites: 56

Brief Summary

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Rating Scale (HAM-A)

  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 Outcomes (1)

• Clinical Global Impression Scale-Severity (CGI-S)

  Week 6

Study Arms (3)

ITI-1284 10 mg

EXPERIMENTAL

Drug: ITI-1284 10 mg

ITI-1284 20 mg

EXPERIMENTAL

Drug: ITI-1284 20 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ITI-1284 10 mg DRUG

ITI-1284 10 mg tablet, taken once daily, sublingual administration.

ITI-1284 10 mg

ITI-1284 20 mg DRUG

ITI-1284 20 mg tablet, taken once daily, sublingual administration.

ITI-1284 20 mg

Placebo DRUG

Matching placebo tablet, taken once daily, sublingual administration

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent before the initiation of any study specific procedures;
• Male or female patients ≥ 18 years of age;
• 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 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;
• 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.

You may not qualify if:

• 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 (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).

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (56)

Behavioral Research Specialists LLC

Glendale, California, 91206, United States

RECRUITING

Sun Valley Research Center

Imperial, California, 92251, United States

RECRUITING

Synergy East

Lemon Grove, California, 91945, United States

RECRUITING

Excell Research Inc

Oceanside, California, 92056, United States

RECRUITING

NRC Research Institute

Orange, California, 92868, United States

RECRUITING

Anderson Clinical Research

Redlands, California, 92374, United States

RECRUITING

Premier Clinical Research

Miami, Florida, 33122, United States

RECRUITING

Global Medical Institutes

Miami, Florida, 33125, United States

RECRUITING

Miami Dade Medical Research Institute

Miami, Florida, 33176, United States

RECRUITING

Sunshine Medical Solution

Miami, Florida, 33186, United States

RECRUITING

South Florida Research Inc

Miami Springs, Florida, 33166, United States

RECRUITING

K2 Medical Research

Tampa, Florida, 33634, United States

RECRUITING

CenExeli Research LLC

Atlanta, Georgia, 30030, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

Michigan Clinical Research Institute

Ann Arbor, Michigan, 48105, United States

RECRUITING

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

RECRUITING

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

RECRUITING

Neuro Behavioral Clinical Research

North Canton, Ohio, 44720, United States

RECRUITING

Sooner Clinical Research

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Lehigh Center for Clinical Research LLC

Allentown, Pennsylvania, 18103, United States

RECRUITING

Suburban Research Associates

Media, Pennsylvania, 19063, United States

RECRUITING

Austin Clinical Trial Partners

Austin, Texas, 78737, United States

RECRUITING

BioBehavioral Research of Austin PC

Austin, Texas, 78759, United States

RECRUITING

Aims Trials LLC

Plano, Texas, 75093, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Medical Center Sv Dimitar Blagoevgrad

Blagoevgrad, 2700, Bulgaria

RECRUITING

Mental Health Center Prof. Dr. Ivan Temkov

Burgas, 8001, Bulgaria

RECRUITING

Outpatient care-group practice for specialized psychiatric care Datamed OOD

Pleven, 5800, Bulgaria

RECRUITING

Medical Center Mentalcare OOD

Plovdiv, 4004, Bulgaria

RECRUITING

Mental Health Center - Rousse

Rousse, 7003, Bulgaria

RECRUITING

Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

Sofia, 1113, Bulgaria

RECRUITING

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

Sofia, 1408, Bulgaria

RECRUITING

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

RECRUITING

Medical Center Intermedica, OOD

Sofia, 1680, Bulgaria

RECRUITING

Medical center - VAS OOD

Targovishte, 7700, Bulgaria

RECRUITING

Diagnostic Consulting Center Mladost - M Varna 1

Varna, 9020, Bulgaria

RECRUITING

Diagnostic Consulting Center Mladost - M Varna

Varna, 9020, Bulgaria

RECRUITING

Mental Health Center - Vratsa EOOD

Vratsa, 3000, Bulgaria

RECRUITING

Medipa S R O

Brno, 60200, Czechia

RECRUITING

A Shine S R O

Pilsen, 301 00, Czechia

RECRUITING

Clintrial s r o

Prague, 10000, Czechia

RECRUITING

Medical Services Prague S R O

Prague, 16000, Czechia

RECRUITING

Institut Neuropsychiatricke pece

Prague, 18600, Czechia

RECRUITING

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, 15-404, Poland

RECRUITING

Przychodnia Srodmiescie SP. z o.o.

Bydgoszcz, 85-080, Poland

RECRUITING

Specjalistyczna Praktyka Lekarska Piotr Zalitacz

Gorlice, 38-300, Poland

RECRUITING

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, 64-100, Poland

RECRUITING

Filip Rybakowski Specjalistyczna Praktyka Lekarska

Poznan, 60 744, Poland

RECRUITING

Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed

Torun, 87 100, Poland

RECRUITING

Institute of Mental Health Serbia

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center of Serbia 1

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

University Clinical Hospital Center Dr Dragisa Misovic- Dedi

Belgrade, 11000, Serbia

RECRUITING

Special Neuropsychiatric Hospital Kovin

Kovin, 26220, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

Novi Kneževac, 23330, Serbia

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Intra-Cellular Therapies,Inc. Clinical Trial

  Intra-Cellular Therapies, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): March 16, 2027
• Study Completion (Estimated): October 21, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (6); SE (7); BU (13); CZ (5); US (25)