A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder Who Have Had Inadequate Response to Generalized Anxiety Disorder Treatment

Intra-Cellular Therapies, Inc.

Summary

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Provide written informed consent before the initiation of any study specific procedures; * 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 scor…

Interventions

Drug
ITI-1284 10 mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
Drug
ITI-1284 20 mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Drug
Placebo
Matching placebo tablet, taken once daily, sublingual administration

Summary

Eligibility

Interventions

Locations (51)