Clinical trial NCT00239356: Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials
Official title: Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol
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: 2005-10-17
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.


Eligibility criteria: Inclusion Criteria:

* Currently receiving aripiprazole at time of screening
* Men and women ages 18 to 70

Exclusion Criteria:

* All patients previously discontinued from an aripiprazole study for any reason
* Active alcohol or substance abuse
* Patients who represent a significant risk of committing suicide
* Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings

Primary outcomes:
measure: Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.
timeFrame: Baseline to Week 348
Secondary outcomes:
measure: Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population
timeFrame: Baseline to Week 348
measure: Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population
timeFrame: Day 1 to Day 1170
measure: Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population
timeFrame: Baseline to end of study (Week 348)
measure: Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population
timeFrame: Baseline to end of study (Week 348)
measure: Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population
timeFrame: Baseline to end of study (Week 348)
measure: Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population
timeFrame: Baseline to end of study (Week 348
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Sherbrooke
country: Canada
facility: Local Institution
state: Quebec
city: Rijeka
country: Croatia
facility: Local Institution
city: Zagreb
country: Croatia
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Prague 6
country: Czech Republic
facility: Local Institution
city: Nantes Orvault
country: France
facility: Local Institution
city: Rennes Cedex
country: France
facility: Local Institution
city: Uzes
country: France
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Gyor
country: Hungary
facility: Local Institution
city: Vught
country: Netherlands
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Westdene
country: South Africa
facility: Local Institution
state: Free State
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Antrim
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: