Actively Recruiting
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
Led by Intra-Cellular Therapies, Inc. · Updated on 2025-07-01
350
Participants Needed
42
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
CONDITIONS
Official Title
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent before any study procedures
- Male or female inpatient between 18 and 75 years old, inclusive
- Diagnosed with bipolar I disorder with a current manic episode or mixed features with or without psychotic symptoms as confirmed by a trained rater
- Young Mania Rating Scale (YMRS) total score of 20 or higher and a score of at least 4 on two of these YMRS items: irritability, speech, content, and disruptive/aggressive behavior at screening and baseline
- Hospitalized voluntarily before screening or admitted to an inpatient unit at Visit 1 with a primary diagnosis of mania within 14 days before screening due to the current manic episode
You will not qualify if you...
- Has a current primary psychiatric diagnosis other than bipolar disorder, including schizophrenia, schizoaffective disorder, other psychotic disorders, dementia, cognitive disorders, intellectual disability, or moderate to severe substance use disorder (excluding nicotine)
- Experiencing first manic episode
- Considered at significant risk of suicidal behavior during the study, including recent suicidal ideation or attempts, high scores on suicidal ideation scales, or considered an imminent danger to self or others
AI-Screening
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Trial Site Locations
Total: 42 locations
1
Clinical Site
Rogers, Arkansas, United States, 72758
Actively Recruiting
2
Clinical Site
Bellflower, California, United States, 90706
Not Yet Recruiting
3
Clinical Site
Culver City, California, United States, 90230
Actively Recruiting
4
Clinical Site
Garden Grove, California, United States, 92845
Actively Recruiting
5
Clinical Site
Lemon Grove, California, United States, 91945
Actively Recruiting
6
Clinical Site
Montclair, California, United States, 91763
Actively Recruiting
7
Clinical Site
Hallandale, Florida, United States, 33009
Actively Recruiting
8
Clinical Site
Hialeah, Florida, United States, 33016
Actively Recruiting
9
Clinical Site
Miami, Florida, United States, 33184
Not Yet Recruiting
10
Clinical Site
Miami Gardens, Florida, United States, 33056
Not Yet Recruiting
11
Clinical Site
Miami Lakes, Florida, United States, 33016
Actively Recruiting
12
Clinical Site
Miami Springs, Florida, United States, 33166
Actively Recruiting
13
Clinical Site
Orlando, Florida, United States, 32807
Actively Recruiting
14
Clinical Site
Atlanta, Georgia, United States, 30324
Actively Recruiting
15
Clinical Site
Atlanta, Georgia, United States, 30338
Not Yet Recruiting
16
Clinical Site
Decatur, Georgia, United States, 30030
Actively Recruiting
17
Clinical Site
Savannah, Georgia, United States, 31405
Actively Recruiting
18
Clinical Site
Shreveport, Louisiana, United States, 71101
Actively Recruiting
19
Clinical Site
Marlton, New Jersey, United States, 08053
Actively Recruiting
20
Clinical Site
North Canton, Ohio, United States, 44720
Actively Recruiting
21
Clinical Site
Austin, Texas, United States, 78701
Not Yet Recruiting
22
Clinical Site
Austin, Texas, United States, 78754
Actively Recruiting
23
Clinical Site
DeSoto, Texas, United States, 75115
Actively Recruiting
24
Clinical Site
Lovech, Bulgaria, 5500
Actively Recruiting
25
Clinical Site
Rousse, Bulgaria
Actively Recruiting
26
Clinical Site
Sofia, Bulgaria, 1377
Actively Recruiting
27
Clinical Site
Stara Zagora, Bulgaria, 6000
Actively Recruiting
28
Clinical Site
Veliko Tarnovo, Bulgaria, 5000
Actively Recruiting
29
Clinical Site
Vratsa, Bulgaria, 3000
Actively Recruiting
30
Clinical Site
Split, Croatia, 21000
Actively Recruiting
31
Clinical Site
Zagreb, Croatia, 10000
Actively Recruiting
32
Clinical Site
Zagreb, Croatia, 10090
Actively Recruiting
33
Clinical Site
Guwahati, Assam, India, 781032
Actively Recruiting
34
Clinical Site
Mangalore, Karnataka, India, 575018
Actively Recruiting
35
Clinical Site
Mysore, Karnataka, India, 570001
Actively Recruiting
36
Clinical Site
Nashik, Maharashtra, India, 422005
Actively Recruiting
37
Clinical Site
Ludhiana, Punjab, India, 141001
Actively Recruiting
38
Clinical Site
Belgrade, Serbia, 11000
Actively Recruiting
39
Clinical Site
Kovin, Serbia, 26220
Actively Recruiting
40
Clinical Site
Kragujevac, Serbia, 34000
Actively Recruiting
41
Clinical Site
Novi Kneževac, Serbia, 23330
Actively Recruiting
42
Clinical Site
Novi Sad, Serbia, 21000
Actively Recruiting
Research Team
I
ITI Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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