Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04959032
• Other study ID #: ITI-007-304
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 8, 2021
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Recurrence
• Schizophrenia

Intervention

Drug:
• Lumateperone 42 mg
Lumateperone 42 mg capsules administered orally, once daily.
• Placebo
Matching capsules administered orally, once daily.

Locations

Country	Name	City	State
Bulgaria	Clinical Site	Burgas
Bulgaria	Clinical Site	Kardzhali
Bulgaria	Clinical Site	Kazanlak
Bulgaria	Clinical Site	Lovech
Bulgaria	Clinical Site	Novi Iskar
Bulgaria	Clinical Site	Pleven
Bulgaria	Clinical Site	Plovdiv
Bulgaria	Clinical Site	Russe
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Targovishte
Bulgaria	Clinical Site	Tsarev Brod
Bulgaria	Clinical Site	Tserova Koria
Bulgaria	Clinical Site	Veliko Tarnovo
Bulgaria	Clinical Site	Vratsa
Poland	Clinical Site	Gdansk
Poland	Clinical Site	Gdansk
Poland	Clinical Site	Gorlice
Poland	Clinical Site	Tuszyn
Serbia	Clinical site	Belgrade
Serbia	Clinical Site	Kovin
Serbia	Clinical Site	Kragujevac
Serbia	Clinical Site	Novi Kneževac
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Austin	Texas
United States	Clinical Site	Bellflower	California
United States	Clinical Site	Berlin	New Jersey
United States	Clinical Site	Boston	Massachusetts
United States	Clinical Site	Cerritos	California
United States	Clinical Site	Chicago	Illinois
United States	Clinical Site	Culver City	California
United States	Clinical Site	DeSoto	Texas
United States	Clinical Site	Garden Grove	California
United States	Clinical Site	Hollywood	Florida
United States	Clinical Site	Las Vegas	Nevada
United States	Clinical Site	Lemon Grove	California
United States	Clinical Site	Little Rock	Arkansas
United States	Clinical Site	Miami Lakes	Florida
United States	Clinical Site	Montclair	California
United States	Clinical Site	North Canton	Ohio
United States	Clinical Site	Oakland Park	Florida
United States	Clinical Site	Orange	California
United States	Clinical Site	Richardson	Texas
United States	Clinical Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.