Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Paliperidone, Treatment response, Schizophrenia, Early prediction, Pharmacokinetics
Brief summary
Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at Day 4. Some second-generation antipsychotics have been found that using the first 2 weeks' treatment results to predict the fourth or sixth week's treatment response is acceptable. The primary aim of this study is to investigate: 1. . whether the early prediction model used in other atypicals could also be applied in paliperidone ER. 2. . The changes of metabolic parameters and pharmacokinetics after paliperidone ER treatment in this study
Detailed description
Patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the 6-week trial. Eligible patients will receive 9mg paliperidone ER first. Then, the dosage of paliperidone could be adjusted two weeks later according to clinical judgement. They will be followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles, glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response.
Interventions
DRUGPaliperidone ER
9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically
Sponsors
Johnson & Johnson Taiwan Ltd
Taipei Institute of Pathology
Taipei City Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) * a minimal baseline total score of 60 on the PANSS * those who had not received long-acting antipsychotic injection for the preceding 6 months * physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators.
Exclusion criteria
* diagnosis of substance (including alcohol) dependence in the previous 6 months * a medical condition that could affect absorption, metabolism, or excretion of the study drug * substantial risk of suicide or violent behavior * pregnancy or breastfeeding * documented organic disease of the central nervous system * unstable or critical untreated medical illness * history of clozapine treatment in the previous 3 months * participation in an investigational drug trial in the 30 days before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS) | Baseline (day 0) and Day 42 |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin) | Day 0 and 42 |
Other
| Measure | Time frame |
|---|---|
| pharmacokinetic (levels of 9-OH risperidone) | day 14 and day 42 |
Countries
Taiwan
Outcome results
None listed