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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Intra-Cellular Therapies, Inc. • ClinicalTrials.gov ID: NCT06701903

Registry updated: 2026-09-25
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Description

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder 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: * Provide written informed consent before the initiation of any study specific procedures; * 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: * HAM-A Total score of ≥ 22; * HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2; * CGI-S score of ≥ 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 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 milligram \[mg\], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms. Exclusion Criteria: * Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: * Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; * Bipolar Disorder; * MADRS total score \> 18 at Screening or Baseline; * In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or * 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; * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; * At Screening or Baseline MADRS Item 10 score ≥ 5; or * The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator; * 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 (that is, at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks)

Conditions

Generalized Anxiety Disorder

Locations

  • University of Alabama at Birmingham — Birmingham, Alabama, United States
  • Woodland International Research Group — Little Rock, Arkansas, United States
  • Woodland Research Northwest — Rogers, Arkansas, United States
  • Proscience Research Group — Culver City, California, United States
  • Leading Edge Research — Encino, California, United States
  • Wake Research PRI Encino — Encino, California, United States
  • CalNeuro Research — Los Angeles, California, United States
  • Excell Research Inc — Oceanside, California, United States
  • California Neuroscience Research — Sherman Oaks, California, United States
  • Pacific Clinical Research Medical Group — Upland, California, United States
  • Sunwise Clinical Research — Walnut Creek, California, United States
  • University of Connecticut Health Center — Farmington, Connecticut, United States
  • Sarkis Clinical Trials — Gainesville, Florida, United States
  • Miami Dade Medical Research Institute — Miami, Florida, United States
  • University of South Florida — Tampa, Florida, United States
  • iResearch Atlanta LLC — Decatur, Georgia, United States
  • Precise Clinical Research, Inc. — Flowood, Mississippi, United States
  • SPRI Clinical Trials, LLC — Brooklyn, New York, United States
  • University of Buffalo — Buffalo, New York, United States
  • Richmond Behavioral Associates — Staten Island, New York, United States
  • The Ohio State University — Columbus, Ohio, United States
  • Sooner Clinical Research — Oklahoma City, Oklahoma, United States
  • Suburban Research Associates — Media, Pennsylvania, United States
  • Relaro Medical Trials — Dallas, Texas, United States
  • Northwest Clinical Research Center — Bellevue, Washington, United States
  • Medical Center Sv Dimitar Blagoevgrad — Blagoevgrad, Bulgaria
  • Medical Center Lifemed — Kardzhali, Bulgaria
  • Medical Center Medconsult-Pleven — Pleven, Bulgaria
  • Medical Center Mentalcare OOD — Plovdiv, Bulgaria
  • Mental Health Center - Rousse — Rousse, 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
  • Prywatne Gabinety Lekarskie PROMEDICUS — Bialystok, Poland
  • Przychodnia Srodmiescie SP. z o.o. — Bydgoszcz, Poland
  • Centrum Zdrowia Alcea — Gdansk, Poland
  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS — Leszno, Poland
  • Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed — Torun, Poland
  • Clinical Center Dr Dragisa Misovic Dedinje — Belgrade, Serbia
  • Institute of Mental Health Serbia — Belgrade, Serbia
  • University Clinical Center of Serbia 1 — Belgrade, Serbia
  • University Clinical Center of Serbia — Belgrade, Serbia
  • Special Neuropsychiatric Hospital Kovin — Kovin, Serbia
  • University Clinical Center Kragujevac — Kragujevac, Serbia
  • University Clinical Center NIS — Niš, Serbia
  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi — Novi Kneževac, Serbia
  • Psychiatricka Ambulancia Mentum S.R.O. — Bratislava, Slovakia
  • Psychiatricka Ambulancia Psycholine S.R.O. — Rimavská Sobota, Slovakia
  • Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk — Svidník, Slovakia
  • Crystal Comfort s.r.o. — Vranov nad Topľou, Slovakia
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Official Source

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

View Official Record