schizophrenia MedDRA version: 8.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Product Name: paliperidone ER 3 mg
Product Code: R076477
Pharmaceutical Form: Tablet
CAS Number: R076477
Other descriptive name: Paliperidone ER
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Subject meets the DSM-IV criteria for schizophrenia; · Subject is previously non-acute, i.e. on the same antipsychotic medication used for the treatment of schizophrenia and CGI-S change of 1 or less in the past 4 weeks before enrollment. Subject has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication; · Male or female, aged = 18 years; · Subject is able to read, understand and sign the Institutional Review Board-approved informed consent form; · Subject is healthy on the basis of a physical examination and vital signs at screening; · Female subjects must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study. Effective methods of birth control include prescription hormonal contraceptives, contraceptive injections, intrauterine devices, double barrier method, contraceptive patch and male partner sterilization. Female subjects must also have a negative urine pregnancy test at screening; · Subjects must be willing and able to fill out self-administered questionnaires. 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: · On clozapine, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months; · Serious unstable medical condition, including known clinically relevant laboratory abnormalities; · History or current symptoms of tardive dyskinesia; · History of neuroleptic malignant syndrome; · Judged to be at high risk for adverse events, violence, or self-harm; · Pregnant or breast-feeding female; · Participation in an investigational drug trial in the 30 days prior to selection; · Known hypersensitivity to paliperidone ER or risperidone; · Inability to swallow the study medication whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile); · Employees of the investigator or study center, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator; · Subjects with a current use or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to explore the efficacy, based on total Positive and Negative Syndrome Scale (PANSS) score, of flexibly dosed paliperidone ER in subjects with schizophrenia previously unsuccessfully treated with other oral antipsychotics. Unsuccessfully treated means that, despite the subject was treated with an adequate dose of an appropriate oral antipsychotic for an adequate period of time, this previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability, lack of compliance and/or other reasons. ;Secondary Objective: Secondary objectives are: · To explore the tolerability and safety of a transition to flexibly dosed paliperidone ER in subjects with schizophrenia previously unsuccessfully treated with other oral antipsychotics; · To explore the characteristics of response within different subgroups of a transition from previous antipsychotic medication to flexibly dosed paliperidone ER. This will be done by assessing: · PANSS · proportion of subjects improving 20% or more in total PANSS from baseline to endpoint · CGI-S · PSP · SF 36 Health Survey · subject satisfaction; · sleep quality and daytime drowsiness · side effect profiles by means of ESRS, physical examination, body weight, vital signs and AEs ;Primary end point(s): The primary efficacy criterion will be the change from baseline in total PANSS score at the end of the main study phase (Week 26 or last post-baseline visit). For the group of subjects that transitioned for the main reason of lack of efficacy, improved efficacy based on the percentage of patients with = 20% improvement in total PANSS will be the primary parameter. For the group of subjects that transitioned for the main reason of lack of tolerability, lack of compliance or other reason, maintained efficacy based on the change in total PANSS, will be the primary parameter. | — |
Countries
Belgium, France, Germany, Italy, Lithuania
Outcome results
None listed