Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

NCT04959032 | Completed Phase 3 FDA Drug

• 1 other identifier: ITI-007-304
• Study Type: interventional
• Target: 228
• Locations: 4 countries
• Sites: 43

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).

Conditions

Schizophrenia

Keywords

Schizophrenia; Relapse Prevention; Maintenance Design

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Lumateperone 42 mg

EXPERIMENTAL

Drug: Lumateperone 42 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lumateperone 42 mg DRUG

Lumateperone 42 mg capsules administered orally, once daily.

Lumateperone 42 mg

Placebo DRUG

Matching capsules administered orally, once daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (43)

Clinical Site

Little Rock, Arkansas, 72211, United States

Location

Clinical Site

Bellflower, California, 907006, United States

Location

Clinical Site

Cerritos, California, 90703, United States

Location

Clinical Site

Culver City, California, 90230, United States

Location

Clinical Site

Garden Grove, California, 92845, United States

Location

Clinical Site

Lemon Grove, California, 91945, United States

Location

Clinical Site

Montclair, California, 91763, United States

Location

Clinical Site

Orange, California, 92869, United States

Location

Clinical Site

Hollywood, Florida, 33021, United States

Location

Clinical Site

Miami Lakes, Florida, 33016, United States

Location

Clinical Site

Oakland Park, Florida, 33334, United States

Location

Clinical Site

Atlanta, Georgia, 30331, United States

Location

Clinical Site

Chicago, Illinois, 60640, United States

Location

Clinical Site

Boston, Massachusetts, 02114, United States

Location

Clinical Site

St Louis, Missouri, 63141, United States

Location

Clinical Site

Las Vegas, Nevada, 89102, United States

Location

Clinical Site

Berlin, New Jersey, 08009, United States

Location

Clinical Site

North Canton, Ohio, 44720, United States

Location

Clinical Site

Austin, Texas, 78754, United States

Location

Clinical Site

DeSoto, Texas, 75115, United States

Location

Clinical Site

Richardson, Texas, 75080, United States

Location

Clinical Site

Burgas, 8000, Bulgaria

Location

Clinical Site

Kardzhali, 6600, Bulgaria

Location

Clinical Site

Kazanlak, 6100, Bulgaria

Location

Clinical Site

Lovech, 5500, Bulgaria

Location

Clinical Site

Novi Iskar, 1282, Bulgaria

Location

Clinical Site

Pleven, 5800, Bulgaria

Location

Clinical Site

Plovdiv, 4002, Bulgaria

Location

Clinical Site

Rousse, 7003, Bulgaria

Location

Clinical Site

Sofia, 1377, Bulgaria

Location

Clinical Site

Targovishte, 7700, Bulgaria

Location

Clinical Site

Tsarev Brod, 9747, Bulgaria

Location

Clinical Site

Tserova Koria, 5047, Bulgaria

Location

Clinical Site

Veliko Tarnovo, 5000, Bulgaria

Location

Clinical Site

Vratsa, 3000, Bulgaria

Location

Clinical Site

Gdansk, 80-214, Poland

Location

Clinical Site

Gdansk, 80-282, Poland

Location

Clinical Site

Gorlice, 3-8300, Poland

Location

Clinical Site

Tuszyn, 95080, Poland

Location

Clinical site

Belgrade, 11000, Serbia

Location

Clinical Site

Kovin, 26220, Serbia

Location

Clinical Site

Kragujevac, 34000, Serbia

Location

Clinical Site

Novi Kneževac, 23330, Serbia

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 12, 2021
• Study Start: July 8, 2021
• Primary Completion: July 25, 2024
• Study Completion: August 7, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (21); SE (4); BU (14); PL (4)