Schizophrenia MedDRA version: 18.1 Level: PT Classification code 10039636 Term: Schizophrenia simple System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: INVEGA TRINZA
Product Name: 273mg paliperidone palmitate extended release suspension for injection (eq. 175mg paliperidone)
Product Code: R092670
Pharmaceutical Form: Suspension for inject
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia ? Able to read, understand, and sign the informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study ? Willing and able to fill out self-administered questionnaires ? Willing and able to adhere to the prohibitions and restrictions specified in the protocol ? A woman of childbearing potential must have a negative urine pregnancy test at Screening and baseline ? A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug 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 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder) ? Experienced intolerable side effects during treatment with paliperidone palmitate 1-month formulation (PP1M) ? Has a known hypersensitivity to paliperidone or risperidone ? Has received any other long-acting injectable antipsychotic medication other than PP1M within the last 4 months before the first injection of the study drug paliperidone palmitate 3-month formulation (PP3M) ? Has received clozapine during the last 3 months before the Screening visit. ? Is considered to be at imminent risk of suicide, even after clinical intervention ? Has a serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities ? Has a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome ? Is a woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of PP3M - Has participated in an investigational drug trial in the 30 days prior to the Screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.;Secondary Objective: To determine : ? Percentage of Participants Achieving Symptomatic remission Based on Positive and Negative Syndrome scale (PANSS) at Month 6, 9 and 12 ? Time to Symptomatic Remission ? Percentage of Participants who Meet the Remission Severity Criteria ? Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF) Endpoint ? Percentage of Participants With PANSS Total Score of greater than or equal to (>=)20 Percent ;Primary end point(s): Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS);Timepoint(s) of evaluation of this end point: At last-observation-carried-forward (LOCF) Endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS) at Month 6, 9 and 12 (2) Time to Symptomatic Remission (3) Percentage of Participants who Meet the Remission Severity Criteria (4) Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF) Endpoint (5) Percentage of Participants With PANSS Total Score of greater than or equal to (>=)20 Percent;Timepoint(s) of evaluation of this end point: (1) Month 6, month 9 , and month 12 (2) - (5) Up to Month 12 | — |
Countries
Croatia, Denmark, France, Germany, Greece, Israel, Italy, Korea, Democratic People's Republic of, Malaysia, Netherlands, Russian Federation, Saudi Arabia, Spain, Taiwan, Turkey, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen Pharmaceutica N.V.
Outcome results
None listed