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A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices

A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00237939
Enrollment
1200
Registered
2005-10-13
Start date
2002-09-30
Completion date
2006-11-30
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

The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.

Interventions

DRUGAripiprazole

Sponsors

Otsuka America Pharmaceutical
CollaboratorINDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Clinical DSM-IV diagnosis of schizophrenia * Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required

Exclusion criteria

* Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes * Prisoners or subjects compulsory detained

Design outcomes

Primary

MeasureTime frame
Clinical Global Impression-Improvement at endpoint

Secondary

MeasureTime frame
Patients' and caregivers' medication preference

Countries

Belgium, France, Netherlands, Portugal, Spain

Outcome results

None listed

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