Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
NCT Number: NCT06480383
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Generalized Anxiety Disorder
Interventions: DRUG: ITI-1284 10 mg|DRUG: ITI-1284 20 mg|DRUG: Placbo
Sponsor: Intra-Cellular Therapies, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 705
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2027-01
Locations: Clinical Site, Chandler, Arizona, 85224, United States|Clinical Site, Encino, California, 91316, United States|Clinical Site, Glendale, California, 91206, United States|Clinical Site, Oceanside, California, 92056, United States|Clinical Site, Orange, California, 92868, United States|Clinical Site, Redlands, California, 92374, United States|Clinical Site, Gainesville, Florida, 32607, United States|Clinical Site, Lauderhill, Florida, 33319, United States|Clinical Site, Maitland, Florida, 32751, United States|Clinical Site, Miami Springs, Florida, 33166, United States|Clinical Site, Miami, Florida, 33012, United States|Clinical Site, Miami, Florida, 33125, United States|Clinical Site, Miami, Florida, 33176, United States|Clinical Site, Orlando, Florida, 32803, United States|Clinical Site, Tampa, Florida, 33609, United States|Clinical Site, Atlanta, Georgia, 30331, United States|Clinical Site, Decatur, Georgia, 30030, United States|Clinical Site, Boston, Massachusetts, 02131, United States|Clinical Site, North Canton, Ohio, 44720, United States|Clinical Site, Oklahoma City, Oklahoma, 73120, United States|Clinical Site, Allentown, Pennsylvania, 18104, United States|Clinical Site, Media, Pennsylvania, 19063, United States|Clinical Site, Austin, Texas, 78737, United States|Clinical Site, Austin, Texas, 78759, United States|Clinical SIte, DeSoto, Texas, 75115, United States|Clinical Site, Plano, Texas, 75093, United States|Clinical Site, Bellevue, Washington, 98007, United States

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.

Primary Outcome Measures: 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 comprises 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., Week 6
Secondary Outcome Measures: 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), Week 6