Efficacy and Safety of Aripiprazole in First Episode Psychosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01026584
• Date of registration: 03/12/2009
• Prospective Registration: No
• Primary sponsor: Chonbuk National University Hospital
• Public title: Efficacy and Safety of Aripiprazole in First Episode Psychosis
• Scientific title: Efficacy and Safety of Aripiprazole in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study
• Date of first enrolment: October 2009
• Target sample size: 55
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01026584
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion 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:

- 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.



Age minimum: 18 Years
Age maximum: 59 Years
Gender: Both

Health Condition(s) or Problem(s) studied

First Episode Psychosis

Intervention(s)

Drug: Aripiprazole

Primary Outcome(s)

Symptoms assessment by objective rating scales [Time Frame: week 1]

Symptoms assessment by objective rating scales [Time Frame: week 2]

Symptoms assessment by objective rating scales [Time Frame: week 3]

Symptoms assessment by objective rating scales [Time Frame: week 6]

Symptoms assessment by objective rating scales [Time Frame: week 4]

Secondary Outcome(s)

Assessment of adverse events by objective rating scales and self report scales [Time Frame: week 4]

Assessment of adverse events by objective rating scales and self report scales [Time Frame: week 1]

Assessment of adverse events by objective rating scales and self report scales [Time Frame: week 6]

Assessment of adverse events by objective rating scales and self report scales [Time Frame: week 2]

Secondary ID(s)

CBIRB0909-97

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Korea Otsuka Pharmaceutical Co.,Ltd.