NCT06229210 Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
| NCT ID | NCT06229210 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Intra-Cellular Therapies, Inc. |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-01-25 |
| Primary Completion | 2032-04-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2024-01-25 with a primary completion date of 2032-04-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
Eligibility Criteria
Inclusion Criteria: * Able to provide consent as follows: * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; * The patient must provide written assent to study enrollment; * Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder; * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). * Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator. Exclusion Criteria: * Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include: * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary. * In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or * At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or * At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or * The patient is considered to be an imminent danger to him/herself or others.
Contact & Investigator
Intra-Cellular Therapies, Inc. Clinical Trial
STUDY DIRECTOR
Intra-Cellular Therapies, Inc.
Frequently Asked Questions
Who can join the NCT06229210 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06229210 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT06229210 currently recruiting?
Yes, NCT06229210 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT06229210 trial being conducted?
This trial is being conducted at Phoenix, United States, Little Rock, United States, Anaheim, United States, Garden Grove, United States and 11 additional locations.
Who is sponsoring the NCT06229210 clinical trial?
NCT06229210 is sponsored by Intra-Cellular Therapies, Inc.. The principal investigator is Intra-Cellular Therapies, Inc. Clinical Trial at Intra-Cellular Therapies, Inc.. The trial plans to enroll 300 participants.
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