Clinical trial NCT00237913: Schizophrenia Trial of Aripiprazole
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2005-10-13
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Score on the Investigator Assessment Questionnaire at week 26
Secondary outcomes:
measure: Clinical Global Impression scale and patient preference of medication at endpoint
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Local Institution
city: Prerov
country: Czech Republic
facility: Local Institution
city: Copenhagen
country: Denmark
facility: Local Institution
city: Horsholm
country: Denmark
facility: Local Institution
city: Helsinki
country: Finland
facility: Local Institution
city: Brumath Cedex
country: France
facility: Local Institution
city: Dole Cedex
country: France
facility: Local Institution
city: Henin Beaumont Cedex
country: France
facility: Local Institution
city: Jonzac Cedex
country: France
facility: Local Institution
city: Nantes Orvault
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Reims Cedex
country: France
facility: Local Institution
city: Rennes
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Uzes
country: France
facility: Local Institution
city: Duisburg
country: Germany
facility: Local Institution
city: Hattingen
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Nuernberg
country: Germany
facility: Local Institution
city: Oldenburg
country: Germany
facility: Local Institution
city: Murcia
country: Spain
facility: Local Institution
city: Bromma
country: Sweden
facility: Local Institution
city: Gothenburgh
country: Sweden
facility: Local Institution
city: Halmstad
country: Sweden
facility: Local Institution
city: Malmo
country: Sweden
facility: Local Institution
city: Sater
country: Sweden
facility: Local Institution
city: Belfast
country: United Kingdom
facility: Local Institution
state: Antrim
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Tunbridge Wells
country: United Kingdom
facility: Local Institution
state: Kent
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Davyhulme
country: United Kingdom
facility: Local Institution
state: Lancashire
city: South Wales
country: United Kingdom
facility: Local Institution
state: Mid Glamorgan
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
affiliation: Centre Hospitalier Guillaume Régnier, service de Psychiatrie adultes
name: Bruno Millet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.