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.
Description
The study will be conducted in 3 periods: * Screening Period (up to 3 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur. * Double-blind Treatment Period (6 weeks) during which patients will be randomized in a 1:1:1 ratio to receive one of the 3 treatments (ITI-1284 10 mg, ITI-1284 20 mg, or placebo). * Safety Follow-up Period (1 week) during which all patients will return for a safety follow-up visit.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 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 (anxious mood) and…
Interventions
- DrugITI-1284 10 mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
- DrugITI-1284 20 mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
- DrugPlacebo
Matching placebo tablet, taken once daily, sublingual administration
Locations (69)
- Clinical SiteChandler, Arizona
- Clinical SiteEncino, California
- Clinical SiteGlendale, California
- Clinical SiteImperial, California
- Clinical SiteLemon Grove, California
- Clinical SiteOceanside, California