Efficacy and Safety of Aripiprazole in First Episode Psychosis

Chonbuk National University

Status and phase: Completed; Phase 4

Conditions: First Episode Psychosis

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01026584

CBIRB0909-97

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

drug

Other group

Treatment:

Drug: Aripiprazole