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

Intra-Cellular Therapies, Inc.

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

Eligibility

Age range: Not specified
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Provide written informed consent before the initiation of any study specific procedures; 2. Male or female patients ≥ 18 years of age; 3. 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: 1. HAM-A Total score of ≥ 22; 2. HAM-A Items 1 (anxi…

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

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