Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 66
Updated:11/23/2013
Start Date:January 2013
End Date:May 2014
Contact:Atlantis Schizophrenia
Email:Otsuka@quintiles.com

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A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia


The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development
program and has been designed to demonstrate the efficacy and safety of aripiprazole IM
depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects
receive treatment during a 12-week double-blind acute treatment phase. The current trial
(31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at
the investigator's discretion, where additional safety and tolerability data will be
collected.


Inclusion Criteria:

- Male and female subjects 18 to 66 years of age, inclusive, at the time of informed
consent.

- Subjects who are able to provide written informed consent (as required by IRB/IEC)
prior to the initiation of any protocol-required procedures.

- Ability, in the opinion of the investigator, to understand the nature of the trial
and follow protocol requirements, including the prescribed dosage regimens, tablet
ingestion, and discontinuation of prohibited concomitant medication, and to be
reliably rated on assessment scales.

- Subjects who have met the completion criteria in the 31-12-291 registrational trial
for the acute treatment of adults with schizophrenia

- Subjects who, in the investigator's judgment, require chronic treatment with
antipsychotic medication and would benefit from extended treatment with an IM depot
formulation.

- Outpatient status at the Week 12 in Trial 291, with the exception of those subjects
eligible to enter Trial 297 due to a positive interim analysis.

Exclusion Criteria:

- Sexually active males of childbearing potential who do not agree to practice 2
different methods of birth control or remain abstinent during the trial and for 180
days after the last dose of trial medication. Sexually active Women of Childbearing
Potential who do not agree to practice 2 different methods of birth control or remain
abstinent during the trial and for 150 days after the last dose of trial medication.

- Females who are breast-feeding and/or who have a positive pregnancy test result prior
to receiving IMP in this trial.

- Subjects experiencing acute depressive symptoms within the past 30 days, according to
the investigator's opinion, that requires treatment with an antidepressant.

- Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers
during the course of the trial.

- Subjects with a significant risk of violent behavior; who represent a risk of
committing suicide; or who in the clinical judgment of the investigator present a
serious risk of suicide.

- Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after
completion of Trial 291.

- Subjects likely to require prohibited concomitant therapy during the trial

- Laboratory test and ECG results which are exclusionary

- Any subject who, in the opinion of the investigator or medical monitor, should not
participate in the trial
We found this trial at
11
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