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Atypical Antipsychotic
Lumateperone for Psychosis (Lumafep Trial)
Phase 4
Recruiting
Led By Juan Bustillo, MD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Lumafep Trial Summary
This trial will examine how two antipsychotics affect dopamine & glutamate in early psychosis patients & compare to healthy controls.
Who is the study for?
This trial is for individuals aged 18-40 with early-stage psychosis or related mental health conditions, who have had limited prior antipsychotic treatment. It excludes those with neurological disorders, intellectual disabilities, severe head trauma history, or active substance use disorders (excluding nicotine and cannabinoids).Check my eligibility
What is being tested?
The study tests the effects of Lumateperone versus Risperidone on brain metabolism in patients with early psychosis. Participants will undergo brain scans to measure glutamate and dopamine levels before and after 6 weeks of treatment.See study design
What are the potential side effects?
Potential side effects may include drowsiness, restlessness, weight gain, dry mouth, blurred vision for both drugs; Lumateperone might also cause less movement-related side effects compared to other antipsychotics.
Lumafep Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positive symptoms
Secondary outcome measures
Correlation between SAS and prolactin
Correlation between circular RNAs and positive symptoms
Correlation between extrapyramidal symptoms and brain dopamine
+5 moreSide effects data
From 2019 Phase 3 trial • 381 Patients • NCT0324937618%
Headache
9%
Somnolence
6%
Nauseau
5%
Dizziness
1%
Mania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumateperone
Placebo
Lumafep Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LumateperoneExperimental Treatment1 Intervention
Lumateperone 42 mg capsule 1 PO QD for 6 weeks
Group II: RisperidoneActive Control1 Intervention
Risperidone starts 1 mg capsule PO QD for 1 week; then titrated blindly per clinical response and tolerability up to: 2 mg capsule QD starting in week 2; up to 3 mg capsule QD starting in week 3; and up to 4 mg capsule QD starting in week 4. Total risperidone exposure of 6 weeks.
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?
University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,754 Total Patients Enrolled
1 Trials studying Psychosis
25 Patients Enrolled for Psychosis
Juan Bustillo, MDPrincipal InvestigatorUNM HSC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a specific psychotic disorder.A close family member has had a psychotic disorder.I have a neurological disorder, intellectual disability, or had severe head trauma.I have a psychiatric disorder but haven't been treated for anxiety or depression in the last year.I have taken 50 mg or less of antipsychotic medication in the past week.I am between 18 and 40 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Lumateperone
- Group 2: Risperidone
Awards:
This trial has 3 awards, including:- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Lumateperone for therapeutic use?
"Data collected from this Phase 4 trial has demonstrated that Lumateperone is a safe intervention, thus awarding it an impressive score of 3."
Answered by AI
What criteria must be met in order to qualify for participation in this experiment?
"This clinical trial is open to people aged 18-40 with psychosis and will be enrolling around 35 participants."
Answered by AI
What is the scope of this research in terms of participants?
"Affirmative. Clinicaltrials.gov indicates that recruitment for this trial is ongoing, with the original posting having been made on May 11th 2023 and last updated on 25th of the same month. At present, 35 eligible patients are needed from one site."
Answered by AI
Can individuals aged 40 or more participate in this experiment?
"Patients aged 18-40 who meet the criteria are eligible for this specific clinical trial."
Answered by AI
Are medical professionals actively recruiting participants for this trial?
"As per the clinicaltrials.gov website, this research study is currently seeking participants. It was initially unveiled to the public on May 11th 2023 and its details were last modified 25 days later."
Answered by AI
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