← Back to Search

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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number and percentage of patients reporting Treatment Emergent Adverse Events
Secondary outcome measures
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

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
2017
Completed Phase 3
~870

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
29 Previous Clinical Trials
6,387 Total Patients Enrolled
7 Trials studying Depression
3,377 Patients Enrolled for Depression

Media Library

Depression Research Study Groups: Lumateperone 42 mg

Frequently Asked Questions

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

What are the negative side-effects of Lumateperone?

"Lumateperone's safety is based on multiple rounds of clinical data, so it received a score of 3."

Answered by AI

Are geriatric patients being sought for this experimental drug testing?

"According to the inclusion criteria, the patients who are eligible for this trial fall between the ages of 18 to 65. Out of the 1,192 trials, 202 are for patients younger than this age bracket and 990 are for those that are older."

Answered by AI

Does this experiment break new ground in the medical field?

"Lumateperone has been under clinical study since 2020. The first official trial was sponsored by Intra-Cellular Therapies, Inc. and took place in 2020 with 450 patients. After the data from the first trial was collected and analyzed, Lumateperone received Phase 3 drug approval. At present, there are 5 ongoing trials being conducted in 56 cities across 7 countries."

Answered by AI

Am I eligible to participate in this experiment?

"This study is looking for 760 participants that suffer from depression and meet the age requirements of 18-65. The most crucial aspect is that, in the opinion of the medical team conducting the study, applicants must have completed the lead-in study without any major complications."

Answered by AI

Is this trial being run in more than one Canadian province?

"Currently, the trial is taking place in 32 different locations, which are situated in Bellevue, Media, Redlands, and a plethora of other cities. If you are considering enrolling, it would be advantageous to choose a location near to where you live to limit travel."

Answered by AI

Are we still looking for participants for this research project?

"According to the official website, this clinical trial is not looking for any more participants at the moment. The study was first posted on October 8th, 2021 and was last updated on April 7th, 2022. Although this trial is not looking for candidates at this time, there are 1349 other studies actively enrolling participants right now."

Answered by AI

How many study participants are being given this medication?

"This research is not recruiting at the moment. The clinical trial was first advertised on October 8th 2021 but was last updated on April 7th 2022. If you're interested in other studies, there are 1344 clinical trials for depression and 5 for Lumateperone that are still recruiting patients."

Answered by AI

What other scientific research has been conducted on Lumateperone?

"There are five ongoing clinical trials studying lumateperone, and five of those are in phase three. Most of the research is taking place in West Palm Beach, Florida, but there are a total of 153 research sites for this treatment."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
New Jersey
Maryland
Other
How old are they?
18 - 65
What site did they apply to?
Clinical Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

i have depression and insomnia. The interest in helping others as well as myself with MDD.
PatientReceived 1 prior treatment
Not happy with current meds, not getting the results I want. I've tried the same drugs for years and I'm nowhere near content. I'd love to be happy.
PatientReceived 2+ prior treatments
I'm suffering from what I believe bto depression due to childhood trauma and ongoing challenges.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

When can I start? what is your physical address?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
2021. "An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061719.
All > Mdd
~0 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top