Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
NCT06480383
This study is recruiting at 25 US sites in 11 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Generalized Anxiety Disorder
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- Any age
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Intra-Cellular Therapies, Inc.
- Last updated on ClinicalTrials.gov
- September 25, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 6
- Behavioral Research Specialists LLC · Glendale, CA
- Sun Valley Research Center · Imperial, CA
- Synergy East · Lemon Grove, CA
- Excell Research Inc · Oceanside, CA
- NRC Research Institute · Orange, CA
- Anderson Clinical Research · Redlands, CA
Florida · 6
- Global Medical Institutes · Miami, FL
- Miami Dade Medical Research Institute · Miami, FL
- Premier Clinical Research · Miami, FL
- Sunshine Medical Solution · Miami, FL
- South Florida Research Inc · Miami Springs, FL
- K2 Medical Research · Tampa, FL
Georgia · 2
- Atlanta Center for Medical Research · Atlanta, GA
- CenExeli Research LLC · Atlanta, GA
Michigan · 1
- Michigan Clinical Research Institute · Ann Arbor, MI
New Jersey · 1
- Bio Behavioral Health · Toms River, NJ
New York · 1
- SPRI Clinical Trials, LLC · Brooklyn, NY
Ohio · 1
- Neuro Behavioral Clinical Research · North Canton, OH
Oklahoma · 1
- Sooner Clinical Research · Oklahoma City, OK
Pennsylvania · 2
- Lehigh Center for Clinical Research LLC · Allentown, PA
- Suburban Research Associates · Media, PA
Texas · 3
- Austin Clinical Trial Partners · Austin, TX
- BioBehavioral Research of Austin PC · Austin, TX
- Aims Trials LLC · Plano, TX
Washington · 1
- Northwest Clinical Research Center · Bellevue, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.