Study of Lumateperone for the Prevention of Relapse in Patients with Schizophrenia

Phase 1

• Conditions: Schizophrenia; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-002068-30-PL
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-08
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1.Provide written informed consent (signed or thumb-printed, in accordance with local regulations to ensure protection of patient’s rights) obtained before the initiation of any study procedures;
2.Patient must identify a caregiver who provides consent to participate in the study;
3.Male or female, 18 to 60 years of age, inclusive;
4.Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM- 5 (modified SCID-5-CT);
5.Diagnosis of schizophrenia for a minimum of 1 year before Visit 1;
6.Current psychotic episode < 4 weeks duration at Visit 1;
7.Positive and Negative Syndrome Scale (PANSS) total score = 70 and= 120 at Visit 1 and Visit 2.
8.Rating of = 4 (moderate) on at least 2 of the following PANSS positive symptoms at Screening (Visit 1) and Baseline (Visit 2): delusions (P1); hallucinatory behavior (P3); conceptual disorganization (P2); and suspiciousness/persecution (P6).
All Inclusion Criteria are presented in Protocol Section 6.4.1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Currently meets DSM-5 criteria for any of the following:
a.Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders, except for schizophrenia;
b.Bipolar I or Bipolar II disorder;
c.Intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders;
d.Known or suspected borderline or antisocial personality disorder or other DSM-5 personality disorder of sufficient severity to interfere with participation in this study;
e.Substance use disorder (other than nicotine) within the 3 months prior to Visit 1 of this study;
2.Patients in their first episode of psychosis;
3.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);
4.History of intolerance or hypersensitivity to a typical or atypical antipsychotic or to designated rescue medications or any history of severe drug allergy or hypersensitivity;
All Exclusion Criteria are presented in Protocol Section 6.4.2.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified