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RECRUITING

NCT06701903

PHASE2

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

Sponsor: Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

570

Start Date

2024-11-21

Completion Date

2027-10-14

Last Updated

2026-08-18

Healthy Volunteers

Conditions

Generalized Anxiety Disorder

Interventions

DRUG

ITI-1284 10 mg

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

DRUG

ITI-1284 20 mg

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

DRUG

Placebo

Matching placebo tablet, taken once daily, sublingual administration

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)

Locations (51)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

Proscience Research Group

Culver City, California, United States

Leading Edge Research

Encino, California, United States

Wake Research PRI Encino

Encino, California, United States

CalNeuro Research

Los Angeles, California, United States

Excell Research Inc

Oceanside, California, United States

California Neuroscience Research

Sherman Oaks, California, United States

Pacific Clinical Research Medical Group

Upland, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Miami Dade Medical Research Institute

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

iResearch Atlanta LLC

Decatur, Georgia, United States

Precise Clinical Research, Inc.

Flowood, Mississippi, United States

SPRI Clinical Trials, LLC

Brooklyn, New York, United States

University of Buffalo

Buffalo, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

The Ohio State University

Columbus, Ohio, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Suburban Research Associates

Media, Pennsylvania, United States

Relaro Medical Trials

Dallas, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Medical Center Sv Dimitar Blagoevgrad

Blagoevgrad, Bulgaria

Medical Center Lifemed

Kardzhali, Bulgaria

Medical Center Medconsult-Pleven

Pleven, Bulgaria

Medical Center Mentalcare OOD

Plovdiv, Bulgaria

Mental Health Center - Rousse

Rousse, Bulgaria

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

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Intermedica, OOD

Sofia, Bulgaria

Medical center - VAS OOD

Targovishte, Bulgaria

Prywatne Gabinety Lekarskie PROMEDICUS

Bialystok, Poland

Przychodnia Srodmiescie SP. z o.o.

Bydgoszcz, Poland

Centrum Zdrowia Alcea

Gdansk, Poland

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, Poland

Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed

Torun, Poland

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, Serbia

Institute of Mental Health Serbia

Belgrade, Serbia

University Clinical Center of Serbia 1

Belgrade, Serbia

University Clinical Center of Serbia

Belgrade, Serbia

Special Neuropsychiatric Hospital Kovin

Kovin, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

University Clinical Center NIS

Niš, Serbia

Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

Novi Kneževac, Serbia

Psychiatricka Ambulancia Mentum S.R.O.

Bratislava, Slovakia

Psychiatricka Ambulancia Psycholine S.R.O.

Rimavská Sobota, Slovakia

Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk

Svidník, Slovakia

Crystal Comfort s.r.o.

Vranov nad Topľou, Slovakia

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (51)