Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing ITI-1284 for Generalized Anxiety Disorder

This study wants 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.

Official registry: https://clinicaltrials.gov/study/NCT07807865 · Intra-Cellular Therapies, Inc. · enrollment listed as 900

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ITI-1284. The registry lists allocation as na. This study wants 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.

They plan to enroll about 900 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

An Open-label, Multicenter Trial to Assess the Long-term Safety and Tolerability of ITI 1284 as Either Adjunctive or Monotherapy Treatment in Patients With Generalized Anxiety Disorder (GAD) With a History of Inadequate Response to GAD Treatment

Interventions: ITI-1284

Primary outcome (registry wording): Number of Participants with Adverse Events (AEs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • for Roll-over participants:
  • Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
  • Ability to follow study instructions and likely to complete all required visits
  • In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)
  • If entering from lead-in study ITI-1284-301, must be expected to continue their ongoing anti-depressant therapy (ADT) or buspirone from the lead-in study
  • who can join for De-novo participants:
  • Male or female participants greater than or equal to (\>=) 18 years of age

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

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FAQ about this NCT record

Is NCT07807865 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07807865?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07807865?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary