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

StatusRecruiting
PhasePhase 2
Started2024-08-05
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Completion pushed: 2027-03-23 → 2027-10-21
2026-08-27
Study Status v6
Re-verified, no change to tracked fields
2026-08-13
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v5
Trial sites reduced: 69 → 56 locations
Primary completion moved earlier: 2027-06 → 2027-03-16
Completion moved earlier: 2027-06 → 2027-03-23
Eligibility criteria+253 characters
[...] on (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater [...] talopram, or buspirone) taken at an adequate dose (at least thea minimum GAD-approvedtotal daily dose perof packageparoxetine insert20 milligrams [mg], venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, daily for at least 6 weeks) for the trea [...] italopram, or buspirone taken at an adequate dose (at least thea minimum GAD-approvedtotal daily dose perof packageparoxetine insert20 mg, venlafaxine XR 75 mg, duloxetine 60 m [...] [...]
Study description-458 characters
The study will be conducted in 3 periods: Screening Period (up to 3 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur. Double-blind Treatment Period (6 weeks) during which patients will be randomized in a 1:1:1 ratio to receive one of the 3 [...]
2026-01-07
Study Status, Contacts/Locations v4
Study sites30→69
2025-02-19
Study Status, Contacts/Locations v3
Study sites28→30
Show 2 earlier versions
2024-11-20
Study Status, Contacts/Locations v2
Primary completion date2026-12→2027-06
Completion date2027-01→2027-06
Study sites29→28
2024-09-23
Study Status, Arms and Interventions, Contacts/Locations v1
Start dateestimated 2024-06→confirmed 2024-08-05
Study sites27→29
InterventionsITI-1284 10 mg (Drug), ITI-1284 20 mg (Drug), Placbo (Drug)→ITI-1284 10 mg (Drug), ITI-1284 20 mg (Drug), Placebo (Drug)
2024-06-24
Original filing
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.
Trial Details
NCT Number NCT06480383
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Generalized Anxiety Disorder
Enrollment 705 participants
Start Date 2024-08-05
Primary Completion 2027-03-16 (estimated)
Study Completion 2027-10-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-25