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Atypical Antipsychotic
Lumateperone for Schizophrenia
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
Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM-5 (modified SCID-5)
Current psychotic episode < 4 weeks duration at Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up number of days from the randomization date to the first relapse date up to 26 weeks.
Awards & highlights
Study Summary
This trial is testing a new drug for people with schizophrenia.
Who is the study for?
Adults aged 18-60 with schizophrenia for at least a year, experiencing moderate symptoms like delusions or hallucinations. They must have a caregiver and be at risk of suicide. Excluded are those with other mental disorders, recent substance abuse, treatment-resistant schizophrenia, or in their first psychosis episode.Check my eligibility
What is being tested?
The study is testing Lumateperone (42 mg) against a placebo to prevent relapse in schizophrenia patients. It's conducted across multiple centers where participants are randomly assigned to either the drug or placebo group without knowing which one they receive.See study design
What are the potential side effects?
While specific side effects for Lumateperone aren't listed here, antipsychotic medications can commonly cause drowsiness, weight gain, dry mouth, restlessness and sometimes more serious conditions like movement disorders or metabolic changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia based on DSM-5 criteria.
Select...
My current psychotic episode has lasted less than 4 weeks.
Select...
I have moderate symptoms of delusions, hallucinations, disorganization, or suspicion.
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I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ number of days from the randomization date to the first relapse date up to 26 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~number of days from the randomization date to the first relapse date up to 26 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first symptom relapse during the Double-blind Treatment Phase
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lumateperone 42 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone 42 mg
2021
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Intra-Cellular Therapies, Inc.Lead Sponsor
29 Previous Clinical Trials
6,947 Total Patients Enrolled
10 Trials studying Schizophrenia
2,188 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 60 years old.I have been diagnosed with schizophrenia for at least a year.I have been diagnosed with schizophrenia based on DSM-5 criteria.You have a score between 70 and 120 on a test that measures the severity of your symptoms.My doctor thinks I might be at risk of harming myself during the study.My current psychotic episode has lasted less than 4 weeks.I have moderate symptoms of delusions, hallucinations, disorganization, or suspicion.My schizophrenia hasn't improved after trying at least 2 different medications for over 6 weeks each.I am between 18 and 60 years old.I have been diagnosed with schizophrenia for at least a year.I have been diagnosed with schizophrenia based on DSM-5 criteria.You have experienced a severe mental breakdown within the last 4 weeks.I have moderate symptoms of delusions, hallucinations, disorganization, or suspicion.
Research Study Groups:
This trial has the following groups:- Group 1: Lumateperone 42 mg
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Schizophrenia Patient Testimony for trial: Trial Name: NCT04959032 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the requirements for volunteers wanting to take part in this research?
"In order to be eligible for this particular clinical trial, patients must have a diagnosis of schizophrenia and be within the ages of 18-60. A total of 200 patients will be admitted into the study."
Answered by AI
Are there any other instances in which Lumateperone 42 mg has been tested?
"Lumateperone 42 mg is being trialled in 5 different Phase 3 clinical studies. Most of these research sites are based in Little Rock, Arkansas, but there are a total of 153 locations running these sorts of investigations."
Answered by AI
Is Lumateperone a safe 42 mg dosage for human patients?
"Lumateperone 42 mg is considered to be a safe medication, as it has progressed to Phase 3 clinical trials. This indicates that not only is there some data supporting its efficacy, but also that there have been multiple rounds of data supporting its safety."
Answered by AI
What is different about this clinical trial?
"Intra-Cellular Therapies, Inc. sponsored the first trial for Lumateperone 42 mg in 2020. The Phase 3 drug approval stage was completed with 450 participants. 5 trials are currently underway across 56 cities and 7 countries. A total of 18267 studies have been conducted since 2020."
Answered by AI
Is this research being conducted with adults only, or are minors also included?
"The age range for this study, as specified in the eligibility requirements, is 18 to 60 years old."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
Clinical Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
The medicine I’m taking isn’t working. I need more medicine that works. I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived 1 prior treatment
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