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Provide written informed consent before the initiation of any study specific procedures;\n2. Male or female patients ≥ 18 years of age;\n3. 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:\n\n   1. HAM-A Total score of ≥ 22;\n   2. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;\n   3. CGI-S score of ≥ 4;\n4. History of inadequate response (\\\u003C 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;\n5. 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.\n\nNOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure.\n\nExclusion Criteria:\n\n1. Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:\n\n   1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;\n   2. Bipolar Disorder;\n2. MADRS total score \\> 18 at Screening or Baseline;\n3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his\u002Fher participation in the study or\n\n   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;\n   2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;\n   3. At Screening or Baseline MADRS Item 10 score ≥ 5; or\n   4. The patient is considered to be an imminent danger to him\u002Fherself or others based on the assessment of the Investigator.\n4. 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).","ALL",{"count":536,"type":537},705,"ESTIMATED","INTERVENTIONAL",[540],"PHASE2","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.",[543],"Generalized Anxiety Disorder","2026-08-13",{"date":546,"type":547},"2026-08-17","ACTUAL",{"date":549,"type":547},"2024-08-05",{"date":551,"type":537},"2027-03-23",{"name":5,"class":6},56]