Actively Recruiting
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Led by Intra-Cellular Therapies, Inc. · Updated on 2025-07-08
500
Participants Needed
50
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The legally authorized representative (parent or guardian) must provide written informed consent
- The patient must provide written assent to participate
- Male or female patients aged 13 to 17 years with schizophrenia
- Male or female patients aged 10 to 17 years with bipolar I or II disorder
- Male or female patients aged 5 to 17 years with autism spectrum disorder
- Meet DSM-5-TR criteria for schizophrenia, bipolar I or II disorder, or autism spectrum disorder confirmed by K-SADS-PL
- Currently an outpatient and expected to remain outpatient during the study
- Rollover patients must have safely completed the lead-in study as judged by the Investigator
You will not qualify if you...
- Primary psychiatric diagnosis other than schizophrenia, bipolar I or II disorder, or autism spectrum disorder
- Schizophrenia with catatonia or bipolar disorder with psychotic features
- Severe or profound intellectual disability in autism spectrum disorder patients
- Significant risk for suicidal behavior as judged by the Investigator
- Positive suicidal ideation items 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale within 6 months before screening or since screening
- One or more suicidal attempts within 2 years before screening
- Score greater than 3 on Item 13 (suicidal ideation) of the CDRS-R for bipolar disorder patients
- Patient considered an imminent danger to self or others
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 50 locations
1
Clinical Site
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Clinical Site
Little Rock, Arkansas, United States, 72204
Actively Recruiting
3
Clinical Site
Anaheim, California, United States, 92805
Actively Recruiting
4
Clinical Site
Colton, California, United States, 92324
Not Yet Recruiting
5
Clinical Site
Garden Grove, California, United States, 92844
Actively Recruiting
6
Clinical Site
Long Beach, California, United States, 90807
Not Yet Recruiting
7
Clinical Site
Redlands, California, United States, 92373
Actively Recruiting
8
Clinical Site
San Diego, California, United States, 92103
Actively Recruiting
9
Clinical Site
West Covina, California, United States, 91790
Actively Recruiting
10
Clinical Site
Colorado Springs, Colorado, United States, 80910
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11
Clinical Site
Gainesville, Florida, United States, 32607
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12
Clinical Site
Hialeah, Florida, United States, 33012
Actively Recruiting
13
Clinical Site
Miami, Florida, United States, 33122
Actively Recruiting
14
Clinical Site
Miami, Florida, United States, 33125
Actively Recruiting
15
Clinical Site
Miami, Florida, United States, 33144
Actively Recruiting
16
Clinical Site
Miami, Florida, United States, 33165
Actively Recruiting
17
Clinical Site
Miami, Florida, United States, 33173
Actively Recruiting
18
Clinical Site
Miami, Florida, United States, 33175
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19
Clinical Site
Miami, Florida, United States, 33176
Actively Recruiting
20
Clinical Site
Miami Gardens, Florida, United States, 33056
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21
Clinical Site
Miami Lakes, Florida, United States, 33014
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22
Clinical Site
Miami Lakes, Florida, United States, 33016
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23
Clinical Site
Miami Springs, Florida, United States, 33166
Actively Recruiting
24
Clinical Site
Orlando, Florida, United States, 32803
Actively Recruiting
25
Clinical Site
Pompano Beach, Florida, United States, 33060
Actively Recruiting
26
Clinical Site
West Palm Beach, Florida, United States, 33407
Actively Recruiting
27
Clinical Site
Atlanta, Georgia, United States, 30331
Actively Recruiting
28
Clinical Site
Decatur, Georgia, United States, 30030
Actively Recruiting
29
Clinical Site
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
30
Clinical Site
Savannah, Georgia, United States, 31405
Actively Recruiting
31
Clinical Site
Naperville, Illinois, United States, 60563
Actively Recruiting
32
Clinical Site
Indianapolis, Indiana, United States, 46202
Actively Recruiting
33
Clinical Site
Bloomfield Hills, Michigan, United States, 48302
Actively Recruiting
34
Clinical Site
Saint Charles, Missouri, United States, 63304
Actively Recruiting
35
Clinical Site
Lincoln, Nebraska, United States, 68526
Actively Recruiting
36
Clinical Site
Las Vegas, Nevada, United States, 89128
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37
Clinical Site
Avon Lake, Ohio, United States, 44012
Actively Recruiting
38
Clinical Site
Cincinnati, Ohio, United States, 45219
Actively Recruiting
39
Clinical Site
Garfield, Ohio, United States, 44125
Actively Recruiting
40
Clinical Site
Oklahoma City, Oklahoma, United States, 73116
Actively Recruiting
41
Clinical Site
Fort Worth, Texas, United States, 76132
Actively Recruiting
42
Clinical Site
Houston, Texas, United States, 77090
Actively Recruiting
43
Clinical Site
Plano, Texas, United States, 75093
Actively Recruiting
44
Clinical Site
Richmond, Texas, United States, 77407
Actively Recruiting
45
Clinical Site
Richmond, Virginia, United States, 232220
Actively Recruiting
46
Clinical Site
Bellevue, Washington, United States, 98007
Actively Recruiting
47
Clinical Site
Everett, Washington, United States, 98201
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48
Clinical Site
Belgrade, Serbia, 11000
Actively Recruiting
49
Clinical Site
Niš, Serbia, 18000
Actively Recruiting
50
Clinical Site
Novi Sad, Serbia, 21000
Actively Recruiting
Research Team
I
ITI Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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