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

First listed
Nov 22, 2024
Start date
Nov 21, 2024
Status verified
Aug 2026
Primary completion
Oct 14, 2027
Completion
Oct 14, 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 (25)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Woodland International Research GroupLittle RockArkansas72211-
Woodland Research NorthwestRogersArkansas72758-
Proscience Research GroupCulver CityCalifornia90230-
Leading Edge ResearchEncinoCalifornia91316-
Wake Research PRI EncinoEncinoCalifornia91316-
CalNeuro ResearchLos AngelesCalifornia90025-
Excell Research IncOceansideCalifornia92056-
California Neuroscience ResearchSherman OaksCalifornia91403-
Pacific Clinical Research Medical GroupUplandCalifornia91786-
Sunwise Clinical ResearchWalnut CreekCalifornia94596-
University of Connecticut Health CenterFarmingtonConnecticut06032-
Sarkis Clinical TrialsGainesvilleFlorida32607-
Miami Dade Medical Research InstituteMiamiFlorida33176-
University of South FloridaTampaFlorida33613-
iResearch Atlanta LLCDecaturGeorgia30030-
Precise Clinical Research, Inc.FlowoodMississippi39232-
SPRI Clinical Trials, LLCBrooklynNew York11235-
University of BuffaloBuffaloNew York14215-
Richmond Behavioral AssociatesStaten IslandNew York10314-
The Ohio State UniversityColumbusOhio43210-
Sooner Clinical ResearchOklahoma CityOklahoma73116-
Suburban Research AssociatesMediaPennsylvania19063-
Relaro Medical TrialsDallasTexas75243-
Northwest Clinical Research CenterBellevueWashington98007-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALWoodland International Research Group· Little Rock, ARWoodland Research Northwest· Rogers, ARProscience Research Group· Culver City, CALeading Edge Research· Encino, CAWake Research PRI Encino· Encino, CA

Related Studies