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Study Summary
This trial is testing a new drug for people with depression who haven't responded to other treatments. It's a double-blind study, which means that neither the patients nor the researchers will know who's receiving the real drug or the placebo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 381 Patients • NCT03249376Trial Design
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- You have sufficient history and medical record confirmation that the ADT is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.I am taking citalopram or escitalopram.The patient's depression symptoms have improved by at least 25% between the initial assessment and the start of the study.My illness severity is moderate or worse, as rated by a professional.My depression is considered at least moderate in severity.You have been diagnosed with certain mental health conditions like schizophrenia, bipolar disorder, or other serious psychotic disorders.Your mood symptoms have improved by at least 25% between the initial assessment and the start of the study.My medical records confirm that my current mental health condition significantly affects my daily life.You have been diagnosed with Major Depressive Disorder (MDD) according to specific criteria outlined in the DSM-5. This diagnosis may include MDD with psychotic features. It will be confirmed by the doctor or an approved rater using a specific assessment called the MINI.My depression hasn't improved much with my current antidepressant.I am between 18 and 65 years old.My first major depressive episode occurred at age 60 or older.My current major depressive episode started between 2 months and 18 months ago.My illness severity is at least moderate, as rated by a professional.I am currently taking fluoxetine.I am taking sertraline.My current major depressive episode started between 2 months and 18 months ago.I am between 18 and 65 years old.My depression is considered at least moderate in severity.I am currently taking paroxetine.My depression score is 14 or higher.
- Group 1: Placebo
- Group 2: Lumateperone 42 mg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the current legal status of Lumateperone in the United States?
"There is existing clinical data and multiple rounds of safety testing for Lumateperone, so it received a score of 3."
Is this a nationwide trial or are the locations limited to specific regions?
"There are presently 17 clinical trial sites operational. These locations include, but are not limited to, Bellevue, Charlotte and San Diego. If you enroll in this study, it is important to try and be placed at a site near you to minimize travel requirements."
If I am 69 years old, would I be able to participate in this research study?
"This particular study is designed for patients that are between 18-65 years old. Out of the total 2,205 clinical trials, 205 are for children and 1,005 arefor adults over the age of 65."
What other research is there on this topic?
"Lumateperone has been under investigation since 2020 by Intra-Cellular Therapies, Inc. The first trial included 450 patients and was followed by the drug's Phase 3 approval in the same year. As of now, there are 5 ongoing studies involving Lumateperone being conducted in 7 nations and 56 cities altogether."
Are people still being signed up for this experiment?
"If you are reading this, it is likely that you qualify for the study. This information was taken from clinicaltrials.gov. The trial was first posted on 9/30/2021 and updated as recently as 4/7/2022."
Are there other scientific papers which touch on Lumateperone's effects?
"Currently, there are five ongoing trials studying lumateperone's effects with 5 of those in Phase 3. Most of the research locations for lumateperone are based in West Palm Beach, Florida; however, there are a total of 153 clinical trial sites across the globe looking into this medication."
How can I sign up for this opportunity to participate in this research?
"To participate in this experiment, individuals must have been diagnosed with involutional psychosis and be between 18-65 years old. A total of 470 will be accepted into the trial."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Clinical Site: < 48 hours
Typically responds via
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