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Antipsychotic
Lumateperone for Bipolar Mania
Phase 3
Recruiting
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female inpatient, between the ages of 18 and 75 years, inclusive
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 3
Awards & highlights
Summary
"This trial is testing a new treatment for patients with bipolar disorder who are experiencing manic episodes. It is a study that involves multiple centers and participants will be randomly assigned to different treatment groups. The study is
Who is the study for?
This trial is for adults aged 18-75 with bipolar I disorder experiencing a manic or mixed episode, possibly with psychotic symptoms. They must meet DSM 5 criteria, have specific scores on the YMRS scale, and be hospitalized due to their current episode. Excluded are those with other primary psychiatric diagnoses, severe substance use disorders (except nicotine), first-time manic episodes, or significant suicidal risk.
What is being tested?
The study tests Lumateperone against a placebo in patients with bipolar mania. It's a multi-center trial where participants are randomly assigned to either the medication or placebo without knowing which one they receive (double-blind). The goal is to evaluate the effectiveness of Lumateperone in acute treatment.
What are the potential side effects?
While not specified here, common side effects of antipsychotics like Lumateperone may include drowsiness, weight gain, dry mouth, restlessness and gastrointestinal issues. Each individual might experience side effects differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Young Mania Rating Scale (YMRS)
Secondary outcome measures
Clinical Global Impression Scale-Severity (CGI-S)
Side effects data
From 2019 Phase 3 trial • 381 Patients • NCT0324937618%
Headache
9%
Somnolence
6%
Nauseau
5%
Dizziness
1%
Mania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumateperone
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lumateperone 42 mgExperimental Treatment1 Intervention
Lumateperone 42 mg capsules
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone
2021
Completed Phase 3
~1360
Find a Location
Who is running the clinical trial?
Intra-Cellular Therapies, Inc.Lead Sponsor
35 Previous Clinical Trials
8,982 Total Patients Enrolled
7 Trials studying Bipolar Disorder
3,186 Patients Enrolled for Bipolar Disorder
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