RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Intra-Cellular Therapies, Inc. • ClinicalTrials.gov ID: NCT06480383

Registry updated: 2026-09-25

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Description

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.

Interventions

ITI-1284 10 mg (Drug)
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
ITI-1284 20 mg (Drug)
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Placebo (Drug)
Matching placebo tablet, taken once daily, sublingual administration

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).

Conditions

Generalized Anxiety Disorder

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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