Schizophrenia MedDRA version: 17.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: paliperidone palmitate - extended release suspension for injection - 50 mg
Product Code: R092670
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: paliperidone palmitat
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Meet the DSM-IV criteria for schizophrenia; Currently non-acute, i.e., on the same antipsychotic medication used for the treatment of schizophrenia given in an adequate dose and a CGI-S change = 80 and a baseline CGI-S score >= 4; Women must be postmenopausal for at least 1 year, surgically sterile, abstinent (at the discretion of the investigator/per local regulations), or if sexually active, be practicing a highly effective method of birth control as local regulations permit, and before entry, must agree to continue to use the same method of contraception throughout the study; Is cooperative and reliable, and agrees to receive regular injections and complete all aspects of the protocol; 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 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: The patient’s psychiatric diagnosis is due to direct pharmacological effects of a substance (e.g., a drug of abuse or medication) or a general medical condition (e.g., clinically notable hypothyroidism); First antipsychotic treatment ever, i.e., patient has never been treated with antipsychotics before and antipsychotic treatment given in this study will be the first antipsychotic treatment that the patient will have ever received; On clozapine during the last 3 months; Patients who remain at imminent risk of suicide even after clinical intervention; Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. Baseline to 6 months or early discontinuation 2. Baseline to 6 months or early discontinuation 3. Baseline to 6 months or early discontinuation;Main Objective: The primary objective is to explore the tolerability, safety and treatment response (maintained/improved efficacy), based on total Positive and Negative Syndrome Scale (PANSS) score, of a transition to flexibly dosed paliperidone palmitate in subjects with schizophrenia previously unsuccessfully treated with oral or long-acting injectable (LAI) antipsychotics. Subjects may present either acute or non-acute symptoms of schizophrenia.;Primary end point(s): 1. Improved efficacy for non-acute patients transitioned due to lack of efficacy, as measured by the total PANSS score at endpoint versus baseline. 2. Improved efficacy for acute patients, as measured by the total PANSS score at endpoint versus baseline. 3. Maintained efficacy for non-acute patients transitioned for other reasons based on PANSS score at endpoint versus baseline.;Secondary Objective: To collect data in order to develop recommendations for use of and transition to paliperidone palmitate from previous oral and LAI antipsychotic medications. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in Clinical Global Impression-Severity Scale [CGI-S] 2. Change from baseline in personal and social functioning (Personal and Social Performance Scale [PSP]) 3. Change from baseline in Health status (Self-reported health status questionnaire [SF-36]) 4. Change from baseline in Measure of Health Outcome (EQ-5D) 5. Change from baseline in Patient well-being (Subjective Well-Being under Neuroleptics Scale [SWN-S]);;Timepoint(s) of evaluation of this end point: 1. Baseline, week 1, month 1, 2, 3 and 6 2. Baseline, week 1, month 1, 2, 3 and 6 3. Baseline, month 3 and 6 4. Baseline, month 3 and 6 5. Baseline, month 3 and 6 | — |
Countries
Austria, Belgium, Croatia, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Portugal, Russian Federation, Serbia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed