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Lumateperone for Depression, Bipolar Disorder

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 day 43
Awards & highlights

Study Summary

This trial is testing whether lumateperone is an effective and safe treatment for patients with bipolar depression or major depressive disorder who also meet criteria for mixed-features. The study includes a screening period, treatment period, and follow-up period to monitor safety.

Eligible Conditions
  • Depression, Bipolar Disorder
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 43 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Åsberg Depression Rating Scale
Secondary outcome measures
Clinical Global Impression Scale - Severity

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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lumateperone 42mgExperimental Treatment1 Intervention
Lumateperone 42mg administered once daily in the evening
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo administered once daily in the evening
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone
2017
Completed Phase 3
~870

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
30 Previous Clinical Trials
7,043 Total Patients Enrolled
Susan Kozauer, MDStudy DirectorIntra-Cellular Therapies, Inc.
3 Previous Clinical Trials
1,464 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study limited to senior citizens or will it include younger patients as well?

"The principal investigator is currently looking for participants that are 75 years old or younger. All individuals that meet this age criteria and are willing to enroll in the study must be over 18 years of age."

Answered by AI

Are there different trial sites for this research project?

"To make things more convenient for potential participants, the 13 clinical sites for this study are located in Lauderhill, Garden Grove, Cedarhurst and other nearby towns. By selecting the site nearest to you, you can minimize travel time and related costs."

Answered by AI

Has Lumateperone been cleared by the FDA?

"Lumateperone is classified as safe by our team at Power. This is due to it being a Phase 3 trial, which means that not only is there some evidence of efficacy, but also that there have been multiple rounds of data supporting safety."

Answered by AI

Are there specific requirements for those who want to join this research project?

"In order to be eligible for this psychiatric study, the patient must suffer from involutional psychosis and be between 18 and 75 years old. Currently, the investigators are looking to enroll a total of 450 individuals."

Answered by AI

How many patients are presently enrolled in this clinical trial?

"From what is published on clinicaltrials.gov, it does appear that this trial is still open for recruitment. This particular study was originally posted on February 27th, 2020 and was edited February 28th, 2022. The aim is to have 450 patients participate from 13 different sites."

Answered by AI

What do we know about Lumateperone from other medical research?

"Currently, there are 5 ongoing clinical trials for Lumateperone, with 5 of them in Phase 3. Of the total 153 locations running these trials, several are situated in West Palm Beach, Florida."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
18 - 65
What site did they apply to?
Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Clinical Site: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
2020. "Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04285515.
~96 spots leftby Apr 2025
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