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.
This is a multicenter, global, 26-week, open-label study to assess the whether it is safe and how hard side effects are to live with of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
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 Lumateperone. The registry lists allocation as na. This is a multicenter, global, 26-week, open-label study to assess the whether it is safe and how hard side effects are to live with of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
They plan to enroll about 300 people at 65 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 Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder
Interventions: Lumateperone
Primary outcome (registry wording): Incidence of Common Adverse Events
Who it is for (from inclusion criteria)
Ages 5 Years to 17 Years
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;
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
Who the registry excludes
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:
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
This study wants to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder comorbidity.
Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to "friendly fire." Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them.
Background: More than 12,000 people have taken part in research at the Experimental Therapeutics \& Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk.
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 NCT06229210?
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 NCT06229210?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.