Actively Recruiting
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
Led by Intra-Cellular Therapies, Inc. · Updated on 2025-07-08
174
Participants Needed
39
Research Sites
120 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 (ASD) in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient has a legally authorized representative (such as a parent or guardian) willing to provide information and accompany the patient to visits
- The legally authorized representative must provide written informed consent
- When appropriate, the patient should provide written assent
- Male or female patients aged 5 to 17 years (currently only those aged 13 to 17 years are eligible for enrollment)
- Diagnosis of Autism Spectrum Disorder according to DSM-5-TR confirmed by 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 associated with ASD at screening and baseline
You will not qualify if you...
- Primary psychiatric diagnosis other than Autism Spectrum Disorder (exceptions: ADHD on stable medication regimen for at least 30 days prior to screening)
- Severe or profound intellectual disability (mild and moderate intellectual disability allowed)
- History or current diagnosis of Rett syndrome or Fragile X syndrome
- Significant risk of suicidal behavior as judged by the investigator
- Suicidal ideation or attempts within specified recent timeframes based on Columbia-Suicide Severity Rating Scale
- Considered an imminent danger to self or others by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 39 locations
1
Clinical Site
Little Rock, Arkansas, United States, 72204
Actively Recruiting
2
Clinical Site
Imperial, California, United States, 92251
Not Yet Recruiting
3
Clinical Site
Sacramento, California, United States, 95817
Not Yet Recruiting
4
Clinical Site
Sherman Oaks, California, United States, 91403
Actively Recruiting
5
Clinical Site
New Haven, Connecticut, United States, 06511
Not Yet Recruiting
6
Clinical Site
Hialeah, Florida, United States, 33012
Actively Recruiting
7
Clinical Site
Miami, Florida, United States, 33122
Actively Recruiting
8
Clinical Site
Miami, Florida, United States, 33130
Actively Recruiting
9
Clinical Site
Miami, Florida, United States, 33144
Actively Recruiting
10
Clinical Site
Miami, Florida, United States, 33165
Actively Recruiting
11
Clinical Site
Miami, Florida, United States, 33173
Actively Recruiting
12
Clinical Site
Miami Gardens, Florida, United States, 33056
Actively Recruiting
13
Clinical Site
Miami Lakes, Florida, United States, 33014
Actively Recruiting
14
Clinical Site
Orlando, Florida, United States, 32803
Actively Recruiting
15
Clinical Site
Orlando, Florida, United States, 32809
Actively Recruiting
16
Clinical Site
Pompano Beach, Florida, United States, 33060
Actively Recruiting
17
Clinical Site
Atlanta, Georgia, United States, 30318
Actively Recruiting
18
Clinical Site
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
19
Clinical Site
Naperville, Illinois, United States, 60563
Actively Recruiting
20
Clinical Site
Evansville, Indiana, United States, 47713
Not Yet Recruiting
21
Clinical Site
Indianapolis, Indiana, United States, 46202
Actively Recruiting
22
Clinical Site
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
23
Clinical Site
Bloomfield Hills, Michigan, United States, 48302
Actively Recruiting
24
Clinical Site
St Louis, Missouri, United States, 63108
Not Yet Recruiting
25
Clinical Site
Lincoln, Nebraska, United States, 68526
Actively Recruiting
26
Clinical Site
Orangeburg, New York, United States, 10962
Actively Recruiting
27
Clinical Site
Staten Island, New York, United States, 10314
Actively Recruiting
28
Clinical Site
The Bronx, New York, United States, 10467
Actively Recruiting
29
Clinical Site
Kinston, North Carolina, United States, 28504
Not Yet Recruiting
30
Clinical Site
Avon Lake, Ohio, United States, 44012
Actively Recruiting
31
Clinical Site
Oklahoma City, Oklahoma, United States, 73116
Actively Recruiting
32
Clinical Site
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
33
Clinical Site
Austin, Texas, United States, 78759
Actively Recruiting
34
Clinical Site
Coppell, Texas, United States, 75019
Not Yet Recruiting
35
Clinical Site
Dallas, Texas, United States, 75251
Actively Recruiting
36
Clinical Site
Fort Worth, Texas, United States, 76104
Actively Recruiting
37
Clinical Site
Houston, Texas, United States, 77090
Actively Recruiting
38
Clinical Site
Richmond, Virginia, United States, 23220
Actively Recruiting
39
Clinical Site
Everett, Washington, United States, 98201
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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