First Episode Psychosis
Conditions
Brief summary
The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.
Interventions
DRUGpaliperidone ER
8 week prospective study
Sponsors
Janssen Korea, Ltd., Korea
Chonbuk National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.
Exclusion criteria
* Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence * Needing another nonantipsychotic psychotropic medication at enrollment * Having a serious or unstable medical illness. * Pregnant or lactating women or women without adequate contraception will be also excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms assessment by objective rating scales | week 1 | PANSS total score, SANS, CGI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of adverse events by objective rating scales and self report scales profile | week 1 | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS |
| Assessment of adverse events by objective rating scales and self report scales | week 2 | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS |
Countries
South Korea
Outcome results
None listed