Schizophrenia study: Lumateperone
Official title Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT06229210
What this study is testing
What is Lumateperone?
Lumateperone is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether lumateperone is safe and well tolerated in children with schizophrenia, bipolar disorder, or autism spectrum disorder.
- Who it's for
- You may be able to join if you are a child or teen with one of these conditions and are not taking other psychiatric medicines.
- What's involved
- You will take lumateperone at a doctor’s office and have regular check‑ups to report how you feel and any side effects.
- Time commitment
- The study lasts 26 weeks and includes visits every few weeks to monitor safety.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17
You may be able to join if
- 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
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or...
- Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.
You likely can't join if
- 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...
- For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed.
- 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...
- 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
See the full eligibility criteria
- 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
- 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...
- Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Garden Grove, California, United States
- Oceanside, California, United States
- Redlands, California, United States
- Sacramento, California, United States
- West Covina, California, United States
- Gainesville, Florida, United States
- Hialeah, Florida, United States
- Homestead, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Miami Lakes, Florida, United States
- Pompano Beach, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Garden Grove, California, United States; Oceanside, California, United States; Redlands, California, United States and 37 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.