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Lumateperone for Depression

Phase 3
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is for people with major depressive disorder (MDD). It is an open-label study, which means all participants will know which treatment they are receiving. The study will last 26 weeks.

Who is the study for?
This trial is for patients with Major Depressive Disorder who completed a previous study safely and are continuing their prescribed antidepressant treatment. Those at significant risk of suicide or unable to follow the study procedures, as well as those with certain abnormal lab results or ECGs, cannot participate.
What is being tested?
The trial is testing Lumateperone as an additional treatment over 26 weeks in patients with depression. It's an open-label study, meaning both researchers and participants know what treatment is being given.
What are the potential side effects?
While specific side effects for Lumateperone in this context aren't listed here, common ones may include drowsiness, restlessness, nausea, changes in appetite or weight; however individual experiences can vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The number and percentage of patients reporting Treatment Emergent Adverse Events
Secondary study objectives
Clinical Global Impression Scale-Severity
Montgomery-Åsberg Depression Rating Scale

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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lumateperone 42 mgExperimental Treatment1 Intervention
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
39 Previous Clinical Trials
9,736 Total Patients Enrolled
8 Trials studying Depression
3,761 Patients Enrolled for Depression

Media Library

Depression Research Study Groups: Lumateperone 42 mg
~186 spots leftby Dec 2025
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