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

Inclusion Criteria:

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

2. Male or female patients ≥ 18 years of age;

3. 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:

4. HAM-A Total score of ≥ 22;

5. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;

6. CGI-S score of ≥ 4;

7. History of inadequate response (< 50% improvement in anxiety symptoms as measured bythe modified Antidepressant Treatment Response Questionnaire [ATRQ] for GAD) to atleast 1 GAD-approved treatment (ie, one of the following GAD-approved treatments:paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at anadequate dose (at least the minimum GAD-approved dose per package insert) andduration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;

8. Currently having an inadequate response to one of the following GAD-approvedtreatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone takenat an adequate dose (at least the minimum GAD-approved dose per package insert) andduration (ie, for at least 6 weeks prior to Screening) and agrees to continue thesame 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-TRpsychiatric diagnoses:

2. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or otherpsychotic disorder;

3. Bipolar Disorder;

4. MADRS total score > 18 at Screening or Baseline;

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

6. 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;

7. At Screening, the patient has had 1 or more suicidal attempts within the 2years prior to Screening;

8. At Screening or Baseline MADRS Item 10 score ≥ 5; or

9. The patient is considered to be an imminent danger to him/herself or othersbased on the assessment of the Investigator.

10. 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).