RecruitingPhase 2NCT06480383

Study of ITI-1284 as an Adjunctive 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 an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment


Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

705 participants

Start Date

Aug 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests ITI-1284, an experimental drug, as an add-on treatment for people with generalised anxiety disorder (GAD) — persistent, excessive worry that is difficult to control — whose anxiety has not improved enough with standard medications. **You may be eligible if...** - You are 18 or older - You have confirmed moderate-to-severe generalised anxiety disorder (GAD) based on structured clinical interview - Your anxiety has not adequately responded (less than 50% improvement) to at least one prior medication for anxiety - Your anxiety severity scores are above specific thresholds on clinical assessments **You may NOT be eligible if...** - You have primary conditions such as bipolar disorder, schizophrenia, or active substance use disorder - You are currently at risk of suicide - You have had a serious reaction to drugs in the same class as ITI-1284 - You are pregnant or breastfeeding 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(69)

Clinical Site

Chandler, Arizona, United States

Clinical Site

Encino, California, United States

Clinical Site

Glendale, California, United States

Clinical Site

Imperial, California, United States

Clinical Site

Lemon Grove, California, United States

Clinical Site

Oceanside, California, United States

Clinical Site

Orange, California, United States

Clinical Site

Redlands, California, United States

Clinical Site

San Diego, California, United States

Clinical Site

Farmington, Connecticut, United States

Clinical Site

Gainesville, Florida, United States

Clinical Site

Lauderhill, Florida, United States

Clinical Site

Maitland, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami Springs, Florida, United States

Clinical Site

Orlando, Florida, United States

Clinical Site

Tampa, Florida, United States

Clinical Site

Atlanta, Georgia, United States

Clinical Site

Decatur, Georgia, United States

Clinical Site

Boston, Massachusetts, United States

Clinical Site

Ann Arbor, Michigan, United States

Clinical Site

Toms River, New Jersey, United States

Clinical Site

Brooklyn, New York, United States

Clinical Site

North Canton, Ohio, United States

Clinical Site

Oklahoma City, Oklahoma, United States

Clinical Site

Allentown, Pennsylvania, United States

Clinical Site

Media, Pennsylvania, United States

Clinical Site

Austin, Texas, United States

Clinical Site

Austin, Texas, United States

Clinical SIte

DeSoto, Texas, United States

Clinical Site

Plano, Texas, United States

Clinical Site

Bellevue, Washington, United States

Clinical Site

Blagoevgrad, Bulgaria

Clinical Site

Burgas, Bulgaria

Clinical Site

Pleven, Bulgaria

Clinical Site

Plovdiv, Bulgaria

Clinical Site

Rousse, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Targovishte, Bulgaria

Clinical Site

Varna, Bulgaria

Clinical Site

Varna, Bulgaria

Clinical Site

Vratsa, Bulgaria

Clinical Site

Brno, Czechia

Clinical Site

Pilsen, Czechia

Clinical Site

Prague, Czechia

Clinical Site

Prague, Czechia

Clinical Site

Prague, Czechia

Clinical Site

Helsinki, Finland

Clinical Site

Kuopio, Finland

Clinical Site

Oulu, Finland

Clinical Site

Tampere, Finland

Clinical Site

Bialystok, Poland

Clinical Site

Bydgoszcz, Poland

Clinical Site

Gorlice, Poland

Clinical Site

Leszno, Poland

Clinical Site

Poznan, Poland

Clinical Site

Torun, Poland

Clinical Site 2

Belgrade, Serbia

Clinical Site 3

Belgrade, Serbia

Clinical Site 4

Belgrade, Serbia

Clinical Site

Belgrade, Serbia

Clinical Site

Kovin, Serbia

Clinical Site

Kragujevac, Serbia

Clinical Site

Novi Kneževac, Serbia

View Full Details on ClinicalTrials.gov

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

Visit

NCT06480383


Related Trials