Taking people in ColombiaPhase 3

Tests lumateperone safety in children with schizophrenia, bipolar or autism

Tests lumateperone's safety in children with schizophrenia, bipolar disorder or autism.

Plain-language title generated from the registry record
Registry title: Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Key facts

Where: Barranquilla and Bello, ColombiaSee the 2 sites
Phase: Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with schizophrenia, bipolar I or II disorder, or autism spectrum disorder. It tests the safety and tolerability of lumateperone over 26 weeks.

Age: 5 to 17 years. Schizophrenia: 13 to 17 years. Bipolar disorder: 10 to 17 years. Autism spectrum disorder: 5 to 17 years.
Sex: Boys and girls can both join.
Disease stage: A confirmed diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder. The patient must be an outpatient and expected to stay one.
Earlier treatment: If taking stimulant medicine for ADHD, the dose must have been stable for 30 days before screening. Patients from the lead-in study must have safely completed it.

Main reasons for not taking part

A main psychiatric diagnosis other than the three named
Schizophrenia with catatonia, or bipolar disorder with psychotic features
Severe or profound intellectual disability in autism spectrum disorder
Significant risk of suicidal behavior, including a recent suicide attempt or recent suicidal thoughts on the rating scale
Being in imminent danger to self or others

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 5 and 17 years old?

Source: NCT06229210, who can take part

Where in Colombia

Centro de Investigaciones y Proyectos en Neurociencias CIPNABarranquilla, ColombiaTaking people
HOMO - ESE Hospital Mental de AntioquiaBello, ColombiaTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: Intra-Cellular Therapies, Inc.
Trial code: NCT06229210 EU 2023-507068-38-00
Record updated: 3 November 2026
Original description: 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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.
ClinicalTrials.gov NCT06229210 · EU CTIS 2023-507068-38-00