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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
Must not have
Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the package insert for the antipsychotic treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial tests lumateperone, a medication for adults with schizophrenia. It aims to see if the drug can balance brain chemicals to improve symptoms like hallucinations and disorganized thinking. Lumateperone is approved for treating schizophrenia and depressive episodes related to bipolar depression in adults.

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.
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.
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 below
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I have been diagnosed with schizophrenia based on DSM-5 criteria.
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My current psychotic episode has lasted less than 4 weeks.
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I have moderate symptoms of delusions, hallucinations, disorganization, or suspicion.
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My schizophrenia hasn't improved after trying at least 2 different medications for over 6 weeks each.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for schizophrenia, particularly second-generation antipsychotics, work by modulating dopamine and serotonin pathways in the brain. These medications typically act as antagonists at dopamine D2 receptors and serotonin 5-HT2A receptors. By blocking dopamine receptors, they help reduce the positive symptoms of schizophrenia, such as hallucinations and delusions, which are thought to be linked to overactive dopamine signaling. The serotonin receptor antagonism helps mitigate some of the side effects associated with dopamine blockade and may also improve negative symptoms and cognitive deficits. This dual action is crucial for patients as it not only addresses the core symptoms of schizophrenia but also enhances overall treatment tolerability and effectiveness.
Dopamine Targeting Drugs for the Treatment of Schizophrenia: Past, Present and Future.Treatment of early onset schizophrenia: recent trends, challenges and future considerations.Targeting the dopamine receptor in schizophrenia: investigational drugs in Phase III trials.

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
35 Previous Clinical Trials
9,132 Total Patients Enrolled
10 Trials studying Schizophrenia
2,188 Patients Enrolled for Schizophrenia

Media Library

Lumateperone (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT04959032 — Phase 3
Schizophrenia Research Study Groups: Lumateperone 42 mg, Placebo
Schizophrenia Clinical Trial 2023: Lumateperone Highlights & Side Effects. Trial Name: NCT04959032 — Phase 3
Lumateperone (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04959032 — Phase 3
Schizophrenia Patient Testimony for trial: Trial Name: NCT04959032 — Phase 3
~47 spots leftby Oct 2025