This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to assess the how well it works, safety, and tolerability of ITI-1284 as this drug alone 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.
Official registry: https://clinicaltrials.gov/study/NCT06701903 · Intra-Cellular Therapies, Inc. · enrollment listed as 570
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are ITI-1284 10 mg, ITI-1284 20 mg, or Placebo. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to assess the how well it works, safety, and tolerability of ITI-1284 as this drug alone 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.
They plan to enroll about 570 people at 51 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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
Interventions: ITI-1284 10 mg, ITI-1284 20 mg, Placebo
Primary outcome (registry wording): Hamilton Anxiety Rating Scale (HAM-A)
Study Contact
Participate-In-This-Study1@its.jnj.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 26 sites outside the US on the same record
Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG).
NCT00018057 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).
NCT04916327 · Official ClinicalTrials.gov record · Virginia Commonwealth University
Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments. this study wants to understand the brain mechanisms that produce fear and anxiety in humans.
NCT05120635 · Official ClinicalTrials.gov record · Duke University
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary