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

Part of paid clinical trials in Glendale, California.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT06480383
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
N/A - 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 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.

Key Dates

First listed
Jun 28, 2024
Start date
Aug 5, 2024
Status verified
Aug 2026
Primary completion
Mar 16, 2027
Completion
Mar 23, 2027

Study Design

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

Arms

  • Experimental: ITI-1284 10 mg
  • Experimental: ITI-1284 20 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

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

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
Behavioral Research Specialists LLCGlendaleCalifornia91206-
Sun Valley Research CenterImperialCalifornia92251-
Synergy EastLemon GroveCalifornia91945-
Excell Research IncOceansideCalifornia92056-
NRC Research InstituteOrangeCalifornia92868-
Anderson Clinical ResearchRedlandsCalifornia92374-
Global Medical InstitutesMiamiFlorida33125-
Miami Dade Medical Research InstituteMiamiFlorida33176-
Premier Clinical ResearchMiamiFlorida33122-
Sunshine Medical SolutionMiamiFlorida33186-
South Florida Research IncMiami SpringsFlorida33166-
K2 Medical ResearchTampaFlorida33634-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
CenExeli Research LLCAtlantaGeorgia30030-
Michigan Clinical Research InstituteAnn ArborMichigan48105-
Bio Behavioral HealthToms RiverNew Jersey08755-
SPRI Clinical Trials, LLCBrooklynNew York11235-
Neuro Behavioral Clinical ResearchNorth CantonOhio44720-
Sooner Clinical ResearchOklahoma CityOklahoma73120-
Lehigh Center for Clinical Research LLCAllentownPennsylvania18103-
Suburban Research AssociatesMediaPennsylvania19063-
Austin Clinical Trial PartnersAustinTexas78737-
BioBehavioral Research of Austin PCAustinTexas78759-
Aims Trials LLCPlanoTexas75093-
Northwest Clinical Research CenterBellevueWashington98007-

Find similar trials in Glendale, CA

By research site
Behavioral Research Specialists LLC· Glendale, CASun Valley Research Center· Imperial, CASynergy East· Lemon Grove, CAExcell Research Inc· Oceanside, CANRC Research Institute· Orange, CAAnderson Clinical Research· Redlands, CA

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