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Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

StatusRecruiting
PhasePhase 2
Started2024-11-21
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 2027 → Oct 14, 2027
See other at-risk trials from Intra-Cellular Therapies, Inc.

Amendment history

2026-08-27
Study Status v4
Completion pushed: 2027-10-14 → 2028-07-20
2026-08-14
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v3
Trial sites reduced: 60 → 51 locations
Primary completion pushed: 2027-06 → 2027-10-14
Completion pushed: 2027-06 → 2027-10-14
Eligibility criteria+187 characters
[...] on (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater [...] tine, escitalopram, or buspirone taken at an adequate dose (that is, at least thea minimum GAD-approvedtotal daily dose perof packageparoxetine insert20 milligram [mg], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) [...] uloxetine, escitalopram, or buspirone) at an adequate dose (iethat is, at least thea minimum total daily dose approvedof forparoxetine GAD20 permg, packagevenlaf [...] [...]
Study description-552 characters
The study will be conducted in 3 periods: Screening Period (up to 2 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur; Double-blind Treatment Period (6 weeks) during which a total of approximately 570 patients are planned to be randomized i [...]
2026-01-07
Study Status, Contacts/Locations v2
Study sites15→60
2025-02-19
Study Status, Contacts/Locations v1
Start dateestimated 2024-11→confirmed 2024-11-21
Study sitesdetails revised at 2 of 15 sites
2024-11-20
Original filing
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.
Trial Details
NCT Number NCT06701903
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Generalized Anxiety Disorder
Enrollment 570 participants
Start Date 2024-11-21
Primary Completion 2027-10-14 (estimated)
Study Completion 2028-07-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-25