Efficacy and Safety of Aripiprazole in First Episode Psychosis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01026584

Enrollment

Registered

2009-12-04

Start date

2009-10-31

Completion date

2012-02-29

Last updated

2012-02-13

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

Conditions

First Episode Psychosis

Brief summary

The aim of the study is to investigate the efficacy and safety of aripiprazole in patients with first episode psychosis.

Interventions

DRUGAripiprazole

6 week prospective study

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

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	week 1	NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026