Actively Recruiting
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
Led by Intra-Cellular Therapies, Inc. · Updated on 2025-07-04
174
Participants Needed
37
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
CONDITIONS
Official Title
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has a legally authorized representative willing to provide safety and condition information and attend visits
- Legally authorized representative must provide written informed consent
- Patient should provide written assent when developmentally appropriate
- Male or female aged 5 to 17 years, currently only ages 13 to 17 eligible for enrollment
- Primary diagnosis of Autism Spectrum Disorder (ASD) confirmed by DSM-5-TR and K-SADS-PL
- Aberrant Behavior Checklist-Irritability subscale score greater than 18 at screening and baseline
- Clinical Global Impression-Severity score greater than 4 for irritability related to ASD at screening and baseline
You will not qualify if you...
- Primary psychiatric diagnosis other than ASD, except ADHD if stable on medication for 30 days before screening and expected to remain stable
- Severe and profound intellectual disability; mild and moderate intellectual disability allowed
- History or current diagnosis of Rett syndrome or Fragile X syndrome
- Significant risk for suicidal behavior including positive suicidal ideation on C-SSRS items 3, 4, or 5 within 6 months before screening or since screening at baseline
- One or more suicide attempts within 2 years before screening
- Considered an imminent danger to self or others by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Clinical Site
Dothan, Alabama, United States, 36303
Actively Recruiting
2
Clinical Site
Peoria, Arizona, United States, 85382
Not Yet Recruiting
3
Clinical Site
Phoenix, Arizona, United States, 85006
Actively Recruiting
4
Clinical Site
Anaheim, California, United States, 92805
Actively Recruiting
5
Clinical Site
Buena Park, California, United States, 90621
Not Yet Recruiting
6
Clinical Site
Corona, California, United States, 92879
Not Yet Recruiting
7
Clinical Site
Oceanside, California, United States, 92056
Actively Recruiting
8
Clinical Site
Redlands, California, United States, 92373
Actively Recruiting
9
Clinical Site
Upland, California, United States, 91786
Actively Recruiting
10
Clinical Site
West Covina, California, United States, 91790
Actively Recruiting
11
Clinical Site
Colorado Springs, Colorado, United States, 80910
Actively Recruiting
12
Clinical Site
Gainesville, Florida, United States, 32607
Actively Recruiting
13
Clinical Site
Jacksonville, Florida, United States, 32258
Actively Recruiting
14
Clinical Site
Miami, Florida, United States, 33125
Actively Recruiting
15
Clinical Site
Miami, Florida, United States, 33175
Actively Recruiting
16
Clinical Site
Miami, Florida, United States, 33176
Actively Recruiting
17
Clinical Site
Miami, Florida, United States, 33186
Actively Recruiting
18
Clinical Site
Miami Lakes, Florida, United States, 33016
Actively Recruiting
19
Clinical Site
Miami Springs, Florida, United States, 33166
Actively Recruiting
20
Clinical Site
West Palm Beach, Florida, United States, 33407
Actively Recruiting
21
Clinical Site
Savannah, Georgia, United States, 31405
Actively Recruiting
22
Clinical Site
Arlington Heights, Illinois, United States, 60005
Not Yet Recruiting
23
Clinical Site
Springfield, Illinois, United States, 62701
Actively Recruiting
24
Clinical Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
25
Clinical Site
Saint Charles, Missouri, United States, 63304
Actively Recruiting
26
Clinical Site
Las Vegas, Nevada, United States, 89128
Actively Recruiting
27
Clinical Site
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
28
Clinical Site
Garfield, Ohio, United States, 44125
Actively Recruiting
29
Clinical Site
Westlake, Ohio, United States, 44145
Actively Recruiting
30
Clinical Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
31
Clinical Site
Dallas, Texas, United States, 75251
Not Yet Recruiting
32
Clinical Site
Frisco, Texas, United States, 75034
Not Yet Recruiting
33
Clinical Site
Houston, Texas, United States, 77089
Actively Recruiting
34
Clinical Site
Plano, Texas, United States, 75093
Actively Recruiting
35
Clinical Site
Richmond, Texas, United States, 77407
Actively Recruiting
36
Clinical Site
Petersburg, Virginia, United States, 23805
Actively Recruiting
37
Clinical Site
Bellevue, Washington, United States, 98007
Actively Recruiting
Research Team
I
ITI Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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