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RECRUITING

NCT06480383

PHASE2

Study of ITI-1284 as an Adjunctive 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 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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

705

Start Date

2024-08-05

Completion Date

2027-03-23

Last Updated

2026-08-17

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: 1. Provide written informed consent before the initiation of any study specific procedures; 2. Male or female patients ≥ 18 years of age; 3. 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: 1. HAM-A Total score of ≥ 22; 2. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2; 3. CGI-S score of ≥ 4; 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; 5. 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. Exclusion Criteria: 1. Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: 1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; 2. Bipolar Disorder; 2. MADRS total score \> 18 at Screening or Baseline; 3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or 1. 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; 2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; 3. At Screening or Baseline MADRS Item 10 score ≥ 5; or 4. The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator. 4. 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).

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)