Phase 3 Schizophrenia Trial, Recruiting NCT06229210 Sponsor: Intra-Cellular Therapies, Inc. Condition: Schizophrenia
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Phase 3 Schizophrenia Trial, Recruiting

NCT06229210
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • A parent or guardian must give written permission for their child to take part, and the patient themselves must also agree in writing to join the study
  • Boys or girls aged 13 to 17 years old with schizophrenia; boys or girls aged 10 to 17 years old with bipolar I or II disorder; or boys or girls aged 5 to 17 years old with autism spectrum disorder
  • The patient must have an official diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder, confirmed using a standard medical interview process
  • The patient must currently be receiving care as an outpatient (not staying in a hospital) and be expected to remain so throughout the study
  • Patients joining from a related earlier study must have completed that study safely, as confirmed by the study doctor

Who may not be able to join:

  • Patients whose main diagnosis is something other than schizophrenia, bipolar I or II disorder, or autism spectrum disorder are not eligible; schizophrenia with catatonia or bipolar disorder with psychotic features are also not allowed
  • Patients with ADHD taking stimulant medication may still be eligible, but only if their ADHD medication dose has been stable for at least 30 days before the study begins and stays the same throughout (confirm with trial site)
  • For autism spectrum disorder patients only: mild or moderate intellectual disability may be allowed, but severe or profound intellectual disability is not
  • Patients who the study doctor believes are at significant risk of suicidal behaviour during the study are not eligible
  • Patients who have answered "yes" to certain serious suicidal thoughts on a standard safety questionnaire within the past 6 months are not eligible
  • Patients who have made one or more suicide attempts in the past 2 years are not eligible
  • Patients with bipolar disorder who score above a certain level on a suicidal thinking scale are not eligible (confirm with trial site)
  • Patients considered to be in immediate danger of harming themselves or others are not eligible

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 646 440-9333

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Intra-Cellular Therapies, Inc.
Registry
ClinicalTrials.gov
Start date
25 January 2024
Est. completion
28 April 2032

Where this trial is recruiting

🇷🇸 Serbia 🇺🇸 United States

Primary endpoints

Incidence of Common Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov