A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT07807865
Phase
PHASE3
Status
Recruiting
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Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

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

Interventions

  • ITI-1284 — DRUG
    ITI-1284 will be administered sublingually.

Study Details

The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.

Key Dates

First listed
Sep 8, 2026
Start date
Sep 3, 2026
Status verified
Sep 2026
Primary completion
Feb 18, 2030
Completion
Mar 4, 2030

Study Design

Enrollment
900 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ITI-1284
    Participants from acute ITI-1284 GAD studies (Study ITI-1284-301 \[NCT06480383\] and Study ITI-1284-302 \[NCT06701903\]) ("roll-over participants") who meet all eligibility criteria will directly enter this study at the completion of Week 6 of the double-blind treatment period of the lead-in studies (Study ITI-1284-301 and Study ITI-1284-302). Roll-over participants will continue with their assigned monotherapy treatment of ITI-1284 or GAD-approved treatment along with ITI-1284 from the lead-in studies during this open label study. De novo participants who meet all eligibility criteria will either receive ITI-1284 monotherapy or ITI-1284 along with GAD approved treatment for up to 52 weeks.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CalNeuro ResearchLos AngelesCalifornia90025-

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By research site
CalNeuro Research· Los Angeles, CA

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