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

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).

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: Lumateperone 42 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Burgas, Bulgaria, 8000
    • Clinical Site
  • Kardzhali, Bulgaria, 6600
    • Clinical Site
  • Kazanlak, Bulgaria, 6100
    • Clinical Site
  • Lovech, Bulgaria, 5500
    • Clinical Site
  • Novi Iskar, Bulgaria, 1282
    • Clinical Site
  • Pleven, Bulgaria, 5800
    • Clinical Site
  • Plovdiv, Bulgaria, 4002
    • Clinical Site
  • Russe, Bulgaria, 7003
    • Clinical Site
  • Sofia, Bulgaria, 1377
    • Clinical Site
  • Targovishte, Bulgaria, 7700
    • Clinical Site
  • Tsarev Brod, Bulgaria, 9747
    • Clinical Site
  • Tserova Koria, Bulgaria, 5047
    • Clinical Site
  • Veliko Tarnovo, Bulgaria, 5000
    • Clinical Site
  • Vratsa, Bulgaria, 3000
    • Clinical Site
• Poland
  • Gdańsk, Poland, 80-214
    • Clinical Site
  • Gdańsk, Poland, 80-282
    • Clinical Site
  • Gorlice, Poland, 3-8300
    • Clinical Site
  • Tuszyn, Poland, 95080
    • Clinical Site
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Site
  • Kovin, Serbia, 26220
    • Clinical Site
  • Kragujevac, Serbia, 34000
    • Clinical Site
  • Novi Kneževac, Serbia, 23330
    • Clinical Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Clinical Site
  • California
    • Bellflower, California, United States, 907006
      • Clinical Site
    • Cerritos, California, United States, 90703
      • Clinical Site
    • Culver City, California, United States, 90230
      • Clinical Site
    • Garden Grove, California, United States, 92845
      • Clinical Site
    • Lemon Grove, California, United States, 91945
      • Clinical Site
    • Montclair, California, United States, 91763
      • Clinical Site
    • Orange, California, United States, 92869
      • Clinical Site
  • Florida
    • Hollywood, Florida, United States, 33021
      • Clinical Site
    • Miami Lakes, Florida, United States, 33016
      • Clinical Site
    • Oakland Park, Florida, United States, 33334
      • Clinical Site
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Clinical Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Clinical Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Clinical Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Clinical Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Clinical Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Clinical Site
  • Ohio
    • North Canton, Ohio, United States, 44720
      • Clinical Site
  • Texas
    • Austin, Texas, United States, 78754
      • Clinical Site
    • DeSoto, Texas, United States, 75115
      • Clinical Site
    • Richardson, Texas, United States, 75080
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching capsules administered orally, once daily.
Experimental: Lumateperone 42 mg	Drug: Lumateperone 42 mg; Lumateperone 42 mg capsules administered orally, once daily.

What is the study measuring?

Primary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Intra-Cellular Therapies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): July 25, 2024
• Study Completion (Actual): August 7, 2024

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Relapse Prevention; Maintenance Design
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes; Disease Attributes; Schizophrenia; Recurrence
• Other Study ID Numbers: ITI-007-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No