Schizophrenia
Conditions
Keywords
Schizophrenia, Relapse Prevention, Maintenance Design
Brief summary
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).
Detailed description
The study will be conducted in the following 5 phases: * A no-drug Screening Phase up to 7 days in duration during which patient eligibility will be assessed; * A 6-week, open-label Run-in Phase (RIP) during which all patients will receive oral lumateperone 42 mg/day; * A 12-week, open-label Stabilization Phase (SP) during which all patients will receive oral lumateperone 42 mg/day; * A Double-blind Treatment Phase (DBTP) 26 weeks in duration during which patients receive either lumateperone 42 mg or placebo (1:1 ratio); * A 2-week Safety Follow-up (SFU) Phase.
Interventions
Lumateperone 42 mg capsules administered orally, once daily.
DRUGPlacebo
Matching capsules administered orally, once daily.
Sponsors
Intra-Cellular Therapies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first symptom relapse during the Double-blind Treatment Phase | Number of days from the randomization date to the first relapse date up to 26 weeks. |
Countries
Bulgaria, Poland, Serbia, United States
Outcome results
None listed