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.
Provide written informed consent before the initiation of any study specific procedures;
HAM-A Total score of ≥ 22;
HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
CGI-S score of ≥ 4;
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
Parallel
ITI-1284 10 mg
DrugITI-1284 10 mg tablet, taken once daily, sublingual administration.
ITI-1284 20 mg
DrugITI-1284 20 mg tablet, taken once daily, sublingual administration.
Placebo
DrugMatching placebo tablet, taken once daily, sublingual administration
Hamilton Anxiety Rating Scale (HAM-A)
The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It is comprised of 14 items that are rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 with a higher score indicating increased severity of anxiety symptoms.
Clinical Global Impression Scale-Severity (CGI-S)
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)
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