Actively Recruiting
Study of Lumateperone in the Treatment of Patients With Bipolar Mania
Led by Intra-Cellular Therapies, Inc. · Updated on 2025-07-01
350
Participants Needed
35
Research Sites
97 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 Treatment of Patients With Bipolar Mania
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent before starting any study procedures
- Male or female inpatient aged 18 to 75 years, inclusive
- Meets DSM-5 criteria for bipolar I disorder with current mania or mania with mixed features, with or without psychotic symptoms, confirmed by a trained rater
- Young Mania Rating Scale (YMRS) total score of 20 or higher, with at least 4 points on two of these items: irritability, speech, content, and disruptive/aggressive behavior at screening and baseline
- Hospitalized voluntarily before screening or admitted within 14 days prior to screening for the current manic episode as the primary diagnosis
You will not qualify if you...
- Has a primary DSM-5 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 a first manic episode
- Considered at significant risk for suicidal behavior during the study, including recent suicidal ideation or attempts as indicated by Columbia-Suicide Severity Rating Scale (C-SSRS) or Montgomery-�c5sberg Depression Rating Scale (MADRS) scores, or judged to be an imminent danger to self or others
AI-Screening
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Trial Site Locations
Total: 35 locations
1
Clinical Site
Bentonville, Arkansas, United States, 72712
Actively Recruiting
2
Clinical Site
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
Clinical Site
Anaheim, California, United States, 92805
Actively Recruiting
4
Clinical Site
Cerritos, California, United States, 90703
Actively Recruiting
5
Clinical Site
Orange, California, United States, 92868
Actively Recruiting
6
Clinical Site
Torrance, California, United States, 90504
Actively Recruiting
7
Clinical Site
Hialeah, Florida, United States, 33012
Actively Recruiting
8
Clinical Site
Miami, Florida, United States, 33122
Actively Recruiting
9
Clinical Site
Miami, Florida, United States, 33135
Actively Recruiting
10
Clinical Site
Miami, Florida, United States, 33145
Actively Recruiting
11
Clinical Site
Miami Lakes, Florida, United States, 33014
Actively Recruiting
12
Clinical Site
Miami Lakes, Florida, United States, 33016
Actively Recruiting
13
Clinical Site
Tampa, Florida, United States, 33629
Actively Recruiting
14
Clinical Site
West Palm Beach, Florida, United States, 33407
Actively Recruiting
15
Clinical Site
Atlanta, Georgia, United States, 30331
Actively Recruiting
16
Clinical Site
Stockbridge, Georgia, United States, 30281
Actively Recruiting
17
Clinical Site
Chicago, Illinois, United States, 60640
Actively Recruiting
18
Clinical Site
Chicago, Illinois, United States, 60641
Actively Recruiting
19
Clinical Site
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
20
Clinical Site
Glen Oaks, New York, United States, 11004
Not Yet Recruiting
21
Clinical Site
Cincinnati, Ohio, United States, 45219
Not Yet Recruiting
22
Clinical Site
Richardson, Texas, United States, 75080
Actively Recruiting
23
Clinical Site
Burgas, Bulgaria, 8000
Actively Recruiting
24
Clinical Site
Kazanlak, Bulgaria, 6100
Actively Recruiting
25
Clinical Site
Plovdiv, Bulgaria, 4002
Actively Recruiting
26
Clinical Site
Sliven, Bulgaria, 8800
Actively Recruiting
27
Clinical Site
Sofia, Bulgaria, 1431
Actively Recruiting
28
Clinical Site
Brasov, Romania, 507190
Actively Recruiting
29
Clinical Site
Bucharest, Romania, 06022
Actively Recruiting
30
Clinical Site
Iași, Romania, 700282
Actively Recruiting
31
Clinical Site
Belgrade, Serbia, 11000
Actively Recruiting
32
Clinical Site
Kovin, Serbia, 26220
Actively Recruiting
33
Clinical Site
Kragujevac, Serbia, 34000
Actively Recruiting
34
Clinical Site
Niš, Serbia
Actively Recruiting
35
Clinical Site
Novi Kneževac, Serbia
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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