A Phase 2 interventional study of ITI-1284 10 mg and ITI-1284 20 mg in Generalized Anxiety Disorder, sponsored by Intra-Cellular Therapies, Inc.. Recruiting at 51 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Intra-Cellular Therapies, Inc. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy 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.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's planned enrollment of 570 is above the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Intra-Cellular Therapies, Inc. is the lead sponsor of 41 studies on the registry; 12 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At Screening, meet , 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:
Exclusion Criteria:
Within the patient's lifetime, has one of the following confirmed psychiatric diagnoses:
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
Drug: ITI-1284 10 mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Drug: ITI-1284 20 mg
Matching placebo tablet, taken once daily, sublingual administration
Drug: Placebo
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Matching placebo tablet, taken once daily, sublingual administration
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 is comprised 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.
Time frame: Week 6
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)
Time frame: Week 6
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Oct 2027, 34 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Generalized Anxiety Disorder →
Intra-Cellular Therapies, Inc. →