NCT00237913

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
9 countries

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
Last Updated

November 8, 2013

Status Verified

July 1, 2008

Enrollment Period

1.1 years

First QC Date

October 11, 2005

Last Update Submit

November 7, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Score on the Investigator Assessment Questionnaire at week 26

Secondary Outcomes (1)

  • Clinical Global Impression scale and patient preference of medication at endpoint

Study Arms (2)

A1

ACTIVE COMPARATOR
Drug: Aripiprazole

B1

ACTIVE COMPARATOR
Drug: Olanzapine or Quetiapine or Risperidone

Interventions

AripiprazoleDRUG

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

Also known as: Abilify
A1
Olanzapine or Quetiapine or RisperidoneDRUG

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.

B1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Local Institution

Vienna, Austria

Location

Local Institution

Přerov, Czechia

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Local Institution

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

Location

Local Institution

Birmingham, West Midlands, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19102734DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

AripiprazoleOlanzapineQuetiapine FumarateRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzodiazepinesBenzazepinesDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingPyrimidinonesPyrimidines

Study Officials

  • Bruno Millet, MD

    Centre Hospitalier Guillaume Régnier, service de Psychiatrie adultes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 13, 2005

Study Start

July 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

November 8, 2013

Record last verified: 2008-07

Locations

SE(5)DE(5)AU(1)CZ(1)ES(1)FR(10)FI(1)GB(7)DK(2)