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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT06701903
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ITI-1284 10 mg — DRUG
    ITI-1284 10 mg tablet, taken once daily, sublingual administration.
  • ITI-1284 20 mg — DRUG
    ITI-1284 20 mg tablet, taken once daily, sublingual administration.
  • Placebo — DRUG
    Matching placebo tablet, taken once daily, sublingual administration

Study Details

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.

Key Dates

Start date
Nov 21, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
570 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ITI-1284 10mg
    ITI-1284 10 mg tablet, taken once daily, sublingual administration.
  • Experimental: ITI-1284 20mg
    ITI-1284 20 mg tablet, taken once daily, sublingual administration.
  • Placebo Comparator: Placebo
    Matching placebo tablet, taken once daily, sublingual administration

Primary Outcome Measure

Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Week 6 ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Clinical SiteBirminghamAlabama35294-
Clinical SiteLittle RockArkansas72211-
Clinical SiteRogersArkansas72758-
Clinical SiteCulver CityCalifornia90230-
Clinical SiteEncinoCalifornia91316-
Clinical Site_2EncinoCalifornia91316-
Clinical SiteLos AngelesCalifornia90025-
Clinical SiteOceansideCalifornia92056-
Clinical SiteSherman OaksCalifornia91403-
Clinical SiteUplandCalifornia91786-
Clinical SiteWalnut CreekCalifornia94596-
Clinical SiteFarmingtonConnecticut06030-
Clinical SiteGainesvilleFlorida32607-
Clinical SiteMiamiFlorida33176-
Cinical SiteOrlandoFlorida32803-
Clinical SiteTampaFlorida33612-
Clinical SiteTampaFlorida33613-
Clinical SiteDecaturGeorgia30030-
Clinical SiteChicagoIllinois60611-
Clinical SiteBostonMassachusetts02131-
Clinical SiteFlowoodMississippi39232-
Clinical SiteBrooklynNew York11235-
Clinical SiteBuffaloNew York14215-
Clinical SiteStaten IslandNew York10314-
Clinical SiteColumbusOhio43210-
Clinical SiteOklahoma CityOklahoma73116-
Clinical SiteMediaPennsylvania19063-
Clinical SiteDallasTexas75231-
Clinical SiteDallasTexas75243-
Clinical SiteBellevueWashington98007-

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By research site
Clinical Site· Birmingham, ALClinical Site· Little Rock, ARClinical Site· Rogers, ARClinical Site· Culver City, CAClinical Site· Encino, CAClinical Site_2· Encino, CA

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