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Schizophrenia Trial of Aripiprazole

NCT ID: NCT00237913

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-08-31

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

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

B1

Group Type ACTIVE_COMPARATOR

Olanzapine or Quetiapine or Risperidone

Intervention Type DRUG

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.

Interventions

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Aripiprazole

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

Intervention Type DRUG

Olanzapine 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.

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bruno Millet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Guillaume Régnier, service de Psychiatrie adultes

Locations

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Local Institution

Vienna, , Austria

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Přerov, , Czechia

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Copenhagen, , Denmark

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Hørsholm, , Denmark

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Helsinki, , Finland

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Brumath, , France

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Dole, , France

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Hénin-Beaumont, , France

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Jonzac, , France

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Nantes Orvault, , France

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Paris, , France

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Reims, , France

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Rennes, , France

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Toulouse, , France

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Uzès, , France

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Duisburg, , Germany

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Hattingen, , Germany

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München, , Germany

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Nuremberg, , Germany

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Oldenburg, , Germany

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Murcia, , Spain

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Bromma, , Sweden

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Gothenburgh, , Sweden

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Halmstad, , Sweden

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Malmo, , Sweden

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Säter, , Sweden

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Belfast, Antrim, United Kingdom

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London, Greater London, United Kingdom

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Royal Tunbridge Wells, Kent, United Kingdom

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Glasgow, Lanarkshire, United Kingdom

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Davyhulme, Lancashire, United Kingdom

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South Wales, Mid Glamorgan, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Countries

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Austria Czechia Denmark Finland France Germany Spain Sweden United Kingdom

References

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Hanssens L, L'Italien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry. 2008 Dec 22;8:95. doi: 10.1186/1471-244X-8-95.

Reference Type DERIVED
PMID: 19102734 (View on PubMed)

Other Identifiers

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CN138-152

Identifier Type: -

Identifier Source: org_study_id