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

Inclusion Criteria

• Provide written informed consent before the initiation of any study specific procedures;
• Male or female patients ≥ 18 years of age;
• 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 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;
• 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

• 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 (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).