An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia
Status: | Active, not recruiting |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/22/2016 |
Start Date: | June 2010 |
End Date: | December 2018 |
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.
300 mg) to subjects with schizophrenia completing the 52-week, open-label safety and
tolerability Study 31-08-248.
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.
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.
Inclusion Criteria:
- Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria,
who completed the open-label extension Study 248 (completed Study 248 study
completion visit, Week 52).
- Subjects who, in the investigator's judgment, may benefit from continued
participation in an aripiprazole IM Depot study.
- The baseline visit for Study 270 (which is the Week 52 visit of Study 248) and the
first injection for Study 270 must occur within 4 weeks (which is defined as 28
[-2/+10] days) of the last injection in Study 248.
- Subjects who are able to provide written informed consent and/or consent obtained
from a legally acceptable representative (as require by IRB/IEC), prior to the
initiation of any protocol-required procedures.
- Subjects able to understand the nature of the study and follow protocol requirements
and who can read and understand the written word in order to complete
patient-reported outcomes measures.
- Outpatient status.
Exclusion Criteria:
- Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including
schizoaffective disorder, MDD, bipolar disorder, delirium, dementia, amnestic or
other cognitive disorders. Also, subjects with borderline, paranoid, histrionic,
schizotypal, schizoid or antisocial personality disorder.
- Subjects who currently meet DSM-IV-TR criteria for substance dependence; including
alcohol and benzodiazepines, but excluding caffeine and nicotine.
- Subjects with a significant risk of violent behavior or a significant risk of
committing suicide based on the investigator's judgment.
- Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment
with aripiprazole or other quinolinones.
- Subjects with a history of neuroleptic malignant syndrome or clinically significant
tardive dyskinesia at screening.
- Electroconvulsive therapy within 180 days prior to entry.
- Any subject who requires or may need any other antipsychotic medications during the
course of the study.
- Aripiprazole IM Depot (including generic formulation) is commercially available in
the subject's country.
- Other protocol specific inclusion/exclusion criteria may apply
We found this trial at
52
sites
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