RecruitingPhase 2NCT06701903

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

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


Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

570 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ITI-1284 for people with moderate-to-severe generalized anxiety disorder (GAD) who have already tried at least two standard anxiety medications without enough relief. **You may be eligible if...** - You have moderate or severe generalized anxiety disorder (GAD), confirmed by a structured clinical interview - Your anxiety symptoms score highly on standard scales (HAM-A score of 22 or more) - You have tried at least 2 of the following medications — paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone — and had less than 50% improvement **You may NOT be eligible if...** - You have a history of schizophrenia, bipolar disorder, or another psychotic disorder - You have significant depression (MADRS score above 18) - You are considered at significant risk for suicidal behavior Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGITI-1284 10 mg

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

DRUGITI-1284 20 mg

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

DRUGPlacebo

Matching placebo tablet, taken once daily, sublingual administration


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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06701903


Related Trials