schizophrenia
Conditions
Interventions
Existing oral antipsychotics will be stopped immediately or tapered off at the
moment treatment with paliperidone ER starts. The recommended starting dose is
6 mg/day. Treatment starts after baselin
Sponsors
Johnson & Johnson Pharmaceutical
Eligibility
Age
18 Years to 99 Years
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 of childbearing potential must also have a negative urine pregnancy test at screening; · Subjects must be willing and able to fill out self-administered questionnaires
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 current or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PANSS-total score | — |
Secondary
| Measure | Time frame |
|---|---|
| PANSS- subscale scores, percentage responders (>= 20 % improvement in total PANSS score), CGI-S score, PSP scale score, SF-36 scores, patient satisfaction with treatment score, quality of sleep scores, ESRS scores, adverse events, body weight and vital signs. | — |
Countries
Netherlands
Outcome results
None listed