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

Generalized Anxiety Disorder

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

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.

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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(56)

Behavioral Research Specialists LLC

Glendale, California, United States

Sun Valley Research Center

Imperial, California, United States

Synergy East

Lemon Grove, California, United States

Excell Research Inc

Oceanside, California, United States

NRC Research Institute

Orange, California, United States

Anderson Clinical Research

Redlands, California, United States

Premier Clinical Research

Miami, Florida, United States

Global Medical Institutes

Miami, Florida, United States

Miami Dade Medical Research Institute

Miami, Florida, United States

Sunshine Medical Solution

Miami, Florida, United States

South Florida Research Inc

Miami Springs, Florida, United States

K2 Medical Research

Tampa, Florida, United States

CenExeli Research LLC

Atlanta, Georgia, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Michigan Clinical Research Institute

Ann Arbor, Michigan, United States

Bio Behavioral Health

Toms River, New Jersey, United States

SPRI Clinical Trials, LLC

Brooklyn, New York, United States

Neuro Behavioral Clinical Research

North Canton, Ohio, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Lehigh Center for Clinical Research LLC

Allentown, Pennsylvania, United States

Suburban Research Associates

Media, Pennsylvania, United States

Austin Clinical Trial Partners

Austin, Texas, United States

BioBehavioral Research of Austin PC

Austin, Texas, United States

Aims Trials LLC

Plano, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Medical Center Sv Dimitar Blagoevgrad

Blagoevgrad, Bulgaria

Mental Health Center Prof. Dr. Ivan Temkov

Burgas, Bulgaria

Outpatient care-group practice for specialized psychiatric care Datamed OOD

Pleven, Bulgaria

Medical Center Mentalcare OOD

Plovdiv, Bulgaria

Mental Health Center - Rousse

Rousse, Bulgaria

Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

Sofia, 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

Diagnostic Consulting Center Mladost - M Varna 1

Varna, Bulgaria

Diagnostic Consulting Center Mladost - M Varna

Varna, Bulgaria

Mental Health Center - Vratsa EOOD

Vratsa, Bulgaria

Medipa S R O

Brno, Czechia

A Shine S R O

Pilsen, Czechia

Clintrial s r o

Prague, Czechia

Medical Services Prague S R O

Prague, Czechia

Institut Neuropsychiatricke pece

Prague, Czechia

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, Poland

Przychodnia Srodmiescie SP. z o.o.

Bydgoszcz, Poland

Specjalistyczna Praktyka Lekarska Piotr Zalitacz

Gorlice, Poland

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, Poland

Filip Rybakowski Specjalistyczna Praktyka Lekarska

Poznan, Poland

Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed

Torun, Poland

Institute of Mental Health Serbia

Belgrade, Serbia

University Clinical Center of Serbia 1

Belgrade, Serbia

University Clinical Center of Serbia

Belgrade, Serbia

University Clinical Hospital Center Dr Dragisa Misovic- Dedi

Belgrade, Serbia

Special Neuropsychiatric Hospital Kovin

Kovin, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

Novi Kneževac, Serbia

View Full Details on ClinicalTrials.gov

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NCT06480383

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