Schizophrenia Trial of Aripiprazole

A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00237913

Enrollment

700

Registered

2005-10-13

Start date

2004-07-31

Completion date

2005-08-31

Last updated

2013-11-08

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

Conditions

Schizophrenia

Brief summary

Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).

Interventions

DRUGAripiprazole

Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.

DRUGOlanzapine or Quetiapine or Risperidone

Olanzapine: Tablets, Oral, 5-20 mg, Once daily, 26 weeks. OR Quetiapine: Tablets, Oral, 100-800 mg, Once daily, 26 weeks. OR Risperidone: Tablets, Oral, 2-8 mg, Once daily, 26 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of schizophrenia * Schizophrenia symptoms not optimally controlled or antipsychotic medication not well tolerated

Exclusion criteria

* Diagnosis of schizoaffective disorder * Patients treatment-resistant to antipsychotics

Design outcomes

Primary

Measure	Time frame
Score on the Investigator Assessment Questionnaire at week 26	—

Secondary

Measure	Time frame
Clinical Global Impression scale and patient preference of medication at endpoint	—

Countries

Austria, Czechia, Denmark, Finland, France, Germany, Spain, Sweden, United Kingdom

Outcome results

None listed

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