An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia (ASPIRE)
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|ClinicalTrials.gov Identifier: NCT01129882|
Recruitment Status : Completed
First Posted : May 25, 2010
Results First Posted : January 6, 2020
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Aripiprazole||Phase 3|
This was an open-label study that enrolled participants with schizophrenia who had completed the 52-week, open-label safety and tolerability Study 31-08-248 and continued to provide aripiprazole IM depot treatment.
Participants received this treatment until aripiprazole IM Depot was commercially available in any dosage (including generic formulations) in the country where the study was being conducted or the commercial availability of aripiprazole IM Depot was terminated by the sponsor, or until the study completion date of 06 Dec 2018 was reached.
Eligible participants entered this study at the end of treatment visit (Week 52) of Study 31-08-248. Participants continued to receive aripiprazole IM depot every month (study months were every 4 weeks, which were defined as 28 [-2/+10] days) as a continuation of their previous monthly dose in Study 31-08-248.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||709 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia|
|Actual Study Start Date :||June 24, 2010|
|Actual Primary Completion Date :||December 6, 2018|
|Actual Study Completion Date :||December 6, 2018|
Experimental: Aripiprazole IM depot
Active treatment of monthly doses of aripiprazole IM depot (300 mg or 400 mg)
Aripiprazole IM depot - 300 mg or 400 mg
- Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Baseline to Month 97 (+/- 3 days) ]
A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity.
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
- Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit [ Time Frame: Baseline, Month 91 ]The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The Last Visit was defined as the last available post-baseline evaluation. A decrease in the CGI-S score indicated disease stability or improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129882