An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia (ASPIRE)
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|ClinicalTrials.gov Identifier: NCT01129882|
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Aripiprazole||Phase 3|
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.
Recruitment is closed.
|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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 6, 2018|
|Actual Study Completion Date :||December 6, 2018|
Experimental: Aripiprazole IM depot
Active treatment of aripiprazole IM depot (300mg or 400mg)
Aripiprazole IM Depot - 300mg or 400mg
- Frequency and severity of adverse effects and serious adverse effects [ Time Frame: 4 weeks ]
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 ]
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.
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
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