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

NCT ID: NCT06480383
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Intra-Cellular Therapies, Inc.
Conditions: Generalized Anxiety Disorder

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 705 participants (Estimated).

What is being studied

Drug: ITI-1284 10 mg
Drug: ITI-1284 20 mg
Drug: Placebo

Who may be eligible

Ages: Not specified in the registry data
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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).

Study locations

56 study locations are listed.

Recruiting site status is explicitly provided for 56 locations; 56 are listed as Recruiting.

Countries: Bulgaria, Czechia, Poland, Serbia, United States

California, United States: 6
Florida, United States: 6
Georgia, United States: 2
Michigan, United States: 1
New Jersey, United States: 1
New York, United States: 1
Ohio, United States: 1
Oklahoma, United States: 1
Pennsylvania, United States: 2
Texas, United States: 3
Washington, United States: 1

Sample of listed locations

Medical Center Sv Dimitar Blagoevgrad — Blagoevgrad, 2700, Bulgaria — Recruiting
Mental Health Center Prof. Dr. Ivan Temkov — Burgas, 8001, Bulgaria — Recruiting
Outpatient care-group practice for specialized psychiatric care Datamed OOD — Pleven, 5800, Bulgaria — Recruiting
Medical Center Mentalcare OOD — Plovdiv, 4004, Bulgaria — Recruiting
Mental Health Center - Rousse — Rousse, 7003, Bulgaria — Recruiting
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD — Sofia, 1408, Bulgaria — Recruiting
Medical Center Hera EOOD — Sofia, 1510, Bulgaria — Recruiting
Medical Center Intermedica, OOD — Sofia, 1680, Bulgaria — Recruiting
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum — Sofia, 1113, Bulgaria — Recruiting
Medical center - VAS OOD — Targovishte, 7700, Bulgaria — Recruiting
Diagnostic Consulting Center Mladost - M Varna — Varna, 9020, Bulgaria — Recruiting
Diagnostic Consulting Center Mladost - M Varna 1 — Varna, 9020, Bulgaria — Recruiting
Mental Health Center - Vratsa EOOD — Vratsa, 3000, Bulgaria — Recruiting
Medipa S R O — Brno, 60200, Czechia — Recruiting
A Shine S R O — Pilsen, 301 00, Czechia — Recruiting
Clintrial s r o — Prague, 10000, Czechia — Recruiting
Institut Neuropsychiatricke pece — Prague, 18600, Czechia — Recruiting
Medical Services Prague S R O — Prague, 16000, Czechia — Recruiting
Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk — Bialystok, 15-404, Poland — Recruiting
Przychodnia Srodmiescie SP. z o.o. — Bydgoszcz, 85-080, Poland — Recruiting
Specjalistyczna Praktyka Lekarska Piotr Zalitacz — Gorlice, 38-300, Poland — Recruiting
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS — Leszno, 64-100, Poland — Recruiting
Filip Rybakowski Specjalistyczna Praktyka Lekarska — Poznan, 60 744, Poland — Recruiting
Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed — Torun, 87 100, Poland — Recruiting
Institute of Mental Health Serbia — Belgrade, 11000, Serbia — Recruiting

Study details

Start date: August 5, 2024
Primary completion date: March 16, 2027
Completion date: October 21, 2027
First posted: June 28, 2024

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06480383
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT06480383 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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