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

Inclusion Criteria:

• Provide written informed consent before the initiation of any study specificprocedures;

• At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, FifthEdition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD asconfirmed by the Investigator or Sponsor-approved rater using the StructuredClinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all ofthe 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 bythe modified Antidepressant Treatment Response Questionnaire [ATRQ] for GAD) to atleast 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR,duloxetine, escitalopram, or buspirone taken at an adequate dose (at least theminimum GAD-approved dose per package insert) and duration (ie, for at least 6 weeksprior to Screening) for the treatment of ongoing GAD symptoms.

Exclusion Criteria:

• Within the patient's lifetime, has one of the following confirmed DSM-5-TRpsychiatric diagnoses:

• Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or otherpsychotic disorder;

• Bipolar Disorder;

• MADRS total score > 18 at Screening or Baseline;

• In the opinion of the Investigator, the patient has a significant risk for suicidalbehavior during his/her participation in the study or

• At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of theC-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 2years 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 othersbased 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 anadequate dose (ie, at least the minimum dose approved for GAD per package insert)and for an adequate duration (ie, at least 6 weeks).