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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
Pivotal Trial

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 below
Select...
I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Young Mania Rating Scale (YMRS)
Secondary study objectives
Clinical Global Impression Scale-Severity (CGI-S)

Side effects data

From 2019 Phase 3 trial • 381 Patients • NCT03249376
18%
Headache
9%
Somnolence
6%
Nauseau
5%
Dizziness
1%
Mania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumateperone
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~2650

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
40 Previous Clinical Trials
10,382 Total Patients Enrolled
~233 spots leftby Mar 2026
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