Actively Recruiting
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Led by Intra-Cellular Therapies, Inc. · Updated on 2025-07-08
384
Participants Needed
59
Research Sites
154 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 who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
CONDITIONS
Official Title
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent by legally authorized representative and written assent by patient
- Male or female patients aged 10 to 17 years inclusive
- Primary diagnosis of bipolar I or bipolar II disorder with current major depressive episode confirmed by clinical interview
- Lifetime history of at least one manic or hypomanic episode
- Current major depressive episode duration between 4 weeks and less than 12 months
- Children's Depression Rating Scale-Revised (CDRS-R) total score of 45 or higher with a score of 5 or higher on depressed feelings item at screening and baseline
- Young Mania Rating Scale (YMRS) score of 15 or less, with a score of 2 or less on elevated mood item at screening and baseline
You will not qualify if you...
- Primary psychiatric diagnosis other than bipolar I or bipolar II disorder (except ADHD with stable treatment for at least 30 days prior to screening expected to remain stable)
- Intellectual disability based on clinical judgment and DSM-5 criteria
- Hospitalization for bipolar manic episode within 30 days before randomization
- Improvement of 25% or more in CDRS-R total score between screening and baseline or CDRS-R score below 45 at baseline
- Significant risk of suicidal behavior as determined by investigator, including recent suicidal ideation or attempts, high suicidal ideation scores on rating scales, or considered imminent danger to self or others
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 59 locations
1
Clinical Site
Dothan, Alabama, United States, 36303
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
Redlands, California, United States, 92373
Actively Recruiting
5
Clinical Site
Sacramento, California, United States, 95817
Not Yet Recruiting
6
Clinical Site
San Diego, California, United States, 92103
Actively Recruiting
7
Clinical Site
West Covina, California, United States, 91790
Actively Recruiting
8
Clinical Site
Colorado Springs, Colorado, United States, 80910
Actively Recruiting
9
Clinical Site
Gainesville, Florida, United States, 32607
Not Yet Recruiting
10
Clinical Site
Hialeah, Florida, United States, 33012
Actively Recruiting
11
Clinical Site
Homestead, Florida, United States, 33030
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12
Clinical Site
Miami, Florida, United States, 33122
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13
Clinical Site
Miami, Florida, United States, 33125
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14
Clinical Site
Miami, Florida, United States, 33130
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15
Clinical Site
Miami, Florida, United States, 33134
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16
Clinical Site
Miami, Florida, United States, 33144
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17
Clinical Site
Miami, Florida, United States, 33165
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18
Clinical Site
Miami, Florida, United States, 33173
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19
Clinical Site
Miami, Florida, United States, 33176
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20
Clinical Site
Miami, Florida, United States, 33186
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21
Clinical Site
Miami Gardens, Florida, United States, 33056
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22
Clinical Site
Miami Lakes, Florida, United States, 33014
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23
Clinical Site
Miami Lakes, Florida, United States, 33016
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24
Clinical Site
Miami Springs, Florida, United States, 33166
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25
Clinical Site
Orlando, Florida, United States, 32803
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26
Clinical Site
West Palm Beach, Florida, United States, 33407
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27
Clinical Site
Atlanta, Georgia, United States, 30318
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28
Clinical Site
Decatur, Georgia, United States, 30030
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29
Clinical Site
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
30
Clinical Site
Savannah, Georgia, United States, 31405
Actively Recruiting
31
Clinical Site
Chicago, Illinois, United States, 60611
Not Yet Recruiting
32
Clinical Site
Indianapolis, Indiana, United States, 46202
Actively Recruiting
33
Clinical Site
Baltimore, Maryland, United States, 21229
Not Yet Recruiting
34
Clinical Site
Bloomfield Hills, Michigan, United States, 48302
Actively Recruiting
35
Clinical Site
Saint Charles, Missouri, United States, 63304
Actively Recruiting
36
Clinical Site
Lincoln, Nebraska, United States, 68526
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37
Clinical Site
Kinston, North Carolina, United States, 28504
Not Yet Recruiting
38
Clinical Site
Avon Lake, Ohio, United States, 44012
Actively Recruiting
39
Clinical Site
Cincinnati, Ohio, United States, 45219
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40
Clinical Site
Garfield, Ohio, United States, 44125
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41
Clinical Site
Westlake, Ohio, United States, 44145
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42
Clinical Site
Oklahoma City, Oklahoma, United States, 73112
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43
Clinical Site
Oklahoma City, Oklahoma, United States, 73116
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44
Clinical Site
Austin, Texas, United States, 78759
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45
Clinical Site
Flower Mound, Texas, United States, 76028
Actively Recruiting
46
Clinical Site
Frisco, Texas, United States, 75034
Not Yet Recruiting
47
Clinical Site
Houston, Texas, United States, 77089
Actively Recruiting
48
Clinical Site
Houston, Texas, United States, 77090
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49
Clinical Site
Richmond, Texas, United States, 77407
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50
Clinical Site
Richmond, Virginia, United States, 23220
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51
Clinical Site
Bellevue, Washington, United States, 98007
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52
Clinical Site
Everett, Washington, United States, 98201
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53
Clinical Site
Ahmedabad, India, 380008
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54
Clinical Site
Aurangabad, India, 431005
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55
Clinical Site
Nashik, India, 422005
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56
Clinical Site
Varanasi, India, 221005
Actively Recruiting
57
Clinical Site
Belgrade, Serbia, 11000
Actively Recruiting
58
Clinical Site
Niš, Serbia, 18000
Actively Recruiting
59
Clinical Site
Novi Sad, Serbia, 21000
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
2
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