Recently diagnosed (1-5 years since diagnosis) schizophrenia. MedDRA version: 14.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: JNJ-16977831-AAA - injection - 25 mg
Product Code: JNJ-16977831
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Paliperidone palmitate
CAS Number: 199739-10-1
Current
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have been meeting the diagnostic criteria for schizophrenia for 1 to 5 years before screening, and have a history of treatment with antipsychotics; Have a history of two or more relapses requiring psychiatric hospitalization in the preceding 24 months, which may include the current acute episode; Experiencing at screening an acute schizophrenic episode with a PANSS total score at screening between 70 and 120, inclusive; Be healthy on the basis of physical examination, medical history and vital signs performed at screening; Woman must be postmenopausal (for at least 1 year) or surgically sterile or abstinent or be practicing an effective method of birth control, must agree to continue to use the same method of contraception throughout the study and must have a negative urine pregnancy test at screening;be able to fill out questionnaires; Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients that have never been treated with antipsychotics before; Treatment resistant patient and/or currently (i.within the last 3 months) treated with clozapine; Substance dependence within 6 months prior to entry and current intravenous drug use or abuse; allergies, hypersensitivity, or intolerance to risperidone or paliperidone or excipients; treatment with a long-acting injectable antipsychotic within three injection cycles prior to screening; newly started psychotherapy program within the two months preceding the treatment phase baseline; evidence of clinically significant hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances in the past 6 months (as determined by medical history, clinical laboratory or ECG results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study; history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome; involuntarily hospitalized patient; pregnant or breast-feeding females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy (primarily through time to relapse) of long-acting injectable (LAI) paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia. ;Secondary Objective: The secondary objectives are to examine additional efficacy, safety and tolerability of paliperidone palmitate compared with treatment as usual with a variety of orally administered antipsychotic medications in monotherapy, until relapse or over maximally 24 months (whichever comes first), in subjects with recently diagnosed schizophrenia, and to compare the effect of paliperidone palmitate to treatment as usual with orally administered antipsychotic medications in monotherapy on clinically important domains.;Primary end point(s): The primary outcome measure is time to a relapse event.;Timepoint(s) of evaluation of this end point: Relapse is assessed from baseline (Day 1) up to maximally 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The percentage of treatment responders defined as achieving > or = 30% improvement in PANSS total score at endpoint versus baseline 2. Changes from baseline in total PANSS score and PANSS sub-domains/symptom factors 3. Changes from baseline in level of functioning (PSP) 4. Overall score and changes from baseline in global severity of illness (CGI-S, CGI C) 5. Measures of patient's mental health, well-being, treatment satisfaction and physician treatment satisfaction;Timepoint(s) of evaluation of this end point: 1. every visit: screening, day 1, 8, 38, 68, 98, 128, 158, 188, 278, 368, 458, 548, 638, 728 and at withdrawal or relapse 2. every visit: screening, day 1, 8, 38, 68, 98, 128, 158, 188, 278, 368, 458, 548, 638, 728 and at withdrawal or relapse 3. screening visit, days 1, 38, 68, 98, 188, 278 368 458 548 638 728 and at withdrawal or relapse 4. every visit: screening, day 1, 8, 38, 68, 98, 128, 158, 188, 278, 368, 458, 548, 638, 728 and at withdrawal or relapse 5. days 1, 188, 368 and 728 and at early withdrawal and relapse | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Jordan, Korea, Republic of, Lithuania, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed