Efficacy and Safety of Aripiprazole in First Episode Psychosis

C

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)

55 participants in 1 patient group

drug
Other group
Treatment:
Drug: Aripiprazole

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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