Efficacy and Safety of Paliperidone in First Episode Psychosis

Efficacy and Safety of Paliperidone in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000009

Enrollment

Registered

2010-06-28

Start date

2010-03-15

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : paliperidone ER 8 week prospective study

Eligibility

Sex/Gender

All

Inclusion criteria

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

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
PANSS total score, SANS, CGI, CAI(Cognitive Assessment Interview)	—

Secondary

Measure	Time frame
NIDSS(Neuroleptic induced deficit syndrome scale), AIMS, BAS, SAS, Lipid profile	—

Countries

Korea, Republic of

Contacts

Public ContactHYESUN SHIN

Chonbuk National University Hospital

ssunny1218@naver.com+82-63-259-3569

Outcome results