An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia (ASPIRE)
Purpose: To continue to provide aripiprazole intramuscular (IM) Depot treatment (400 mg or 300 mg) to subjects with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia|
- Frequency and severity of adverse effects and serious adverse effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
The primary measures are (1) frequency and severity of adverse events, (2) frequency and severity of serious adverse events (including adverse events related to laboratory abnormalities), and (3) rates of discontinuation from study due to adverse events.
Safety and tolerability data will be summarized as follows: incidence of adverse events and serious adverse events (with severity grades) will be tabulated by MedDRA terms; incidence of discontinuations due to AE will be tabulated by MedDRA terms.
- Mean change from baselines [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Mean change from baseline of vital signs parameters, laboratory tests, and ECG parameters will be provided by visit. Incidence of clinically significant abnormalities in vital signs parameters, laboratory tests, and ECG parameters will be tabulated. Weight gain or loss and injection site reactions will be summarized.
Mean and mean change from baseline in the efficacy endpoint CGI-S score will be summarized.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: Aripiprazole IM depot
Active treatment of aripiprazole IM depot (300mg or 400mg)
Aripiprazole IM Depot - 300mg or 400mg
This is an open-label study which will enroll subjects with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248 and will continue to provide aripiprazole intramuscular (IM) Depot treatment.
Subjects can receive this treatment until aripiprazole IM Depot is commercially available in any dosage (including generic formulations) in the country that the study is being conducted or the commercial availability of aripiprazole IM Depot is terminated by the sponsor, or until the study end date of 31 Dec 2018 is reached.
Eligible subjects will enter this study at the End of Treatment visit (Week 52) of Study 248. Subjects will continue to receive aripiprazole IM Depot every month (study months are every 4 weeks which is defined as 28 [-2/+10] days) as a continuation of their previous monthly dose in Study 248.
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