Schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Lumateperone
Product Code: ITI-007
Pharmaceutical Form: Capsule
INN or Proposed INN: lumateperone tosylate
CAS Number: 1187020-80-9
Other descriptive name: ITI-007 tosylate, ITI-007, FP-
Sponsors
Intra-Cellular Therapies, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy and safety of lumateperone relative to placebo in the prevention of relapse of symptoms in patients with schizophrenia.;Secondary Objective: Not applicable;Primary end point(s): Relapse during the DBTP is defined as meeting 1 or more of the following relapse criteria: •Psychiatric hospitalization or need for increased level of psychiatric care due to worsening of the patient’s underlying condition; •Demonstrate an increase in PANSS total score by = 30% for patients with PANSS total score = 50 at randomization or demonstrate a = 10- point or more increase in PANSS total score for patients who scored 4 on 1 or more of the following PANSS items: P1, P2, P3, P6, P7, G8 or G14. NOTE: The patient should also meet this criterion at a second assessment that is 4 to 7 days apart unless, based on Investigator discretion, a second assessment cannot be performed due to severity of symptoms. ;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is time to first symptom relapse during the DBTP, defined as the number of days from the randomization date to the first relapse date. | — |
Countries
Bulgaria, Croatia, Poland, Serbia, Ukraine, United States
Contacts
Public ContactITI Clinical Trials
Intra-Cellular Therapies. Inc.
Outcome results
None listed