NCT04959032CompletedPhase 3
Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 592 (actual)
- First submitted
- 30 Jun 2021
- Start date
- 8 Jul 2021
- Primary completion date
- 25 Jul 2024
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Diseases
- Schizophrenia
- NCT number
- NCT04959032
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 592
- From 8 Jul 2021 to the primary completion date, 25 Jul 2024
- 42 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently meeting DSM-5 criteria for any of the following:
- Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders; Bipolar I or Bipolar II Disorder; Intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders; Known or suspected borderline or antisocial personality disorder or other DSM 5 personality disorder of sufficient severity to interfere with participation in this study; Substance use disorder (other than nicotine) within the 3 months prior to Visit 1 of this study.
Other
- Patients in their first episode of psychosis.
- 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).
Who the study is looking for
- Male or female, 18 to 60 years of age, inclusive.
- Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM-5 (modified SCID-5).
- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1.
- Current psychotic episode \< 4 weeks duration at Visit 1.
- PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.
- Rating of at least 4 (moderate) on at least two of the following four PANSS positive symptoms: delusions (P1), hallucinatory behavior (P3), conceptual disorganization (P2), suspiciousness/persecution (P6) at Visit 1 and Visit 2.
- Patient must identify a caregiver who provides consents to participate in the study.
- In the opinion of the Investigator, the patient has significant risk for suicidal behavior during the course of his/her participation in the study.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.