Clinical trial NCT04959032: Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Relapse Prevention
Maintenance Design
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Time to first symptom relapse during the Double-blind Treatment Phase
timeFrame: Number of days from the randomization date to the first relapse date up to 26 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Site
state: Arkansas
city: Bellflower
country: United States
facility: Clinical Site
state: California
city: Cerritos
country: United States
facility: Clinical Site
state: California
city: Culver City
country: United States
facility: Clinical Site
state: California
city: Garden Grove
country: United States
facility: Clinical Site
state: California
city: Lemon Grove
country: United States
facility: Clinical Site
state: California
city: Montclair
country: United States
facility: Clinical Site
state: California
city: Orange
country: United States
facility: Clinical Site
state: California
city: Hollywood
country: United States
facility: Clinical Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Site
state: Florida
city: Oakland Park
country: United States
facility: Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Clinical Site
state: Illinois
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Clinical Site
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Site
state: Nevada
city: Berlin
country: United States
facility: Clinical Site
state: New Jersey
city: North Canton
country: United States
facility: Clinical Site
state: Ohio
city: Austin
country: United States
facility: Clinical Site
state: Texas
city: DeSoto
country: United States
facility: Clinical Site
state: Texas
city: Richardson
country: United States
facility: Clinical Site
state: Texas
city: Burgas
country: Bulgaria
facility: Clinical Site
city: Kardzhali
country: Bulgaria
facility: Clinical Site
city: Kazanlak
country: Bulgaria
facility: Clinical Site
city: Lovech
country: Bulgaria
facility: Clinical Site
city: Novi Iskar
country: Bulgaria
facility: Clinical Site
city: Pleven
country: Bulgaria
facility: Clinical Site
city: Plovdiv
country: Bulgaria
facility: Clinical Site
city: Russe
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Targovishte
country: Bulgaria
facility: Clinical Site
city: Tsarev Brod
country: Bulgaria
facility: Clinical Site
city: Tserova Koria
country: Bulgaria
facility: Clinical Site
city: Veliko Tarnovo
country: Bulgaria
facility: Clinical Site
city: Vratsa
country: Bulgaria
facility: Clinical Site
city: Gdańsk
country: Poland
facility: Clinical Site
city: Gdańsk
country: Poland
facility: Clinical Site
city: Gorlice
country: Poland
facility: Clinical Site
city: Tuszyn
country: Poland
facility: Clinical Site
city: Belgrade
country: Serbia
facility: Clinical site
city: Kovin
country: Serbia
facility: Clinical Site
city: Kragujevac
country: Serbia
facility: Clinical Site
city: Novi Kneževac
country: Serbia
facility: Clinical Site
Study officials:
References: