Schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: TREVICTA 350 mg prolonged release suspension for injection
Product Name: 546mg paliperidone palmitate extended release suspension for injection (eq. 350mg paliperidone)
Product Code: R0926
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential subject must satisfy all of the following criteria to be enrolled in the study: 1.Male or female subjects. 2.Must be 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) to 70 years of age, inclusive, at the time of informed consent. 3.Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening. 4.Must be receiving treatment with paliperidone palmitate (as either the PP1M or PP3M formulation), or injectable risperidone, or any oral antipsychotic. a.If the treatment is paliperidone palmitate, then: 1) The dose strength must be PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq. 2) The dose timing must fit the study schedule. The next injection must be due within 28 days of the first screening (or first rescreening) visit. b.If the treatment is injectable risperidone, then the dose strength must be 50 mg, the dosing cycle must be every 2 weeks, the efficacy and tolerability must have been established as adequate with the same strength and frequency for at least 3 injection cycles before screening, and the subject must have a preference for a longer-acting injectable medication. c.If the treatment is an oral antipsychotic, then the subject must have a valid reason to discontinue the previous treatment, such as problems with efficacy, safety, or tolerability, or preference for a long-acting injectable medication. 5.Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M or PP3M during the Screening Phase. 6.Must have a full PANSS score of =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the study: 1.Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment. 2.Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening. 3.Must not have a DSM-5 diagnosis of moderate to severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator. 4.Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia. 5Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe. 6. Must not have been treated with injectable formulations of neuroleptic drugs based on active ingredients other than risperidone or paliperidone (eg, haloperidol decanoate, fluphenazine decanoate, etc) during the 6 months before screening. Please refer to protocol for additional exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • The primary efficacy objective is to demonstrate that injection cycles consisting of a single administration of PP6M (700 or 1000 mg eq.) are not less effective than 2 sequentially administered injections of PP3M (350 or 525 mg eq.) for the prevention of relapse in subjects with schizophrenia previously stabilized on corresponding doses of PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).;Secondary Objective: To Evaluate the • safety & tolerability of PP6M (700 or 1000 mg eq.) in subjects with schizophrenia who have switched from corresponding doses of PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.). • PK profile of PP6M (700 or 1000 mg eq.) administered in the gluteal muscle in subjects with schizophrenia who have switched from corresponding doses of PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.). • clinically assessed efficacy of PP6M (700 or 1000 mg eq.) v. PP3M (350 or 525 mg eq.) in maintaining symptom control, functioning personally and socially, and achieving or sustaining remission in subjects with schizophrenia who were previously stabilized on corresponding doses of PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.). • subject-reported efficacy outcomes of PP6M (700 or 1000 mg eq.) or PP3M (350 or 525 mg eq.) compared with treatment with previous oral antipsychotics in terms of satisfaction with medication & with participation in social roles. ;Primary end point(s): 1. Time to relapse during the Double-blind Phase. This noninferiority primary endpoint will be based on the difference in Kaplan-Meier 12-month estimate of survival (ie, percentage of subjects remaining relapse-free) between PP6M and PP3M.;Timepoint(s) of evaluation of this end point: Time between participant randomization into the Double-Blind phase and the first documentation of a relapse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1)the PANSS total score and subscale scores, (2)the Clinical Global Impression - Severity (CGI-S), and (3) the Personal and Social Performance (PSP) scale. (4)Additionally, the proportion of subjects during the Double blind Phase who meet criteria for symptomatic ;Timepoint(s) of evaluation of this end point: (1), (2) and (3): changes from baseline during the =12 months of the Double-blind Phase (4): from the first 6 month time point to the end of the double blind phase | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Korea, Republic of, Malaysia, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed