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

Otsuka Pharmaceutical Development & Commercialization,0 个研究点目标入组 125 人开始时间: 2013年1月25日最近更新: 2014年5月12日

适应症

试验速览

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•Male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent.
•2. Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the
•initiation of any protocol-required procedures.
•3. 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
•4. Subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute
•treatment of adults with schizophrenia.
•5. Subjects who, in the investigator’s judgment, require chronic treatment with antipsychotic
•medication and would benefit from extended treatment with an IM depot formulation.
•6. Outpatient status at the Week 12 visit in Trial 291.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 124
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•1. 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 WOCBP 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.
•2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to
•receiving IMP in this trial.
•3. Subjects experiencing acute depressive symptoms within the past 30 days, according to the
•investigator’s opinion, that requires treatment with an antidepressant.
•4. Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers
•during the course of the trial.
•5. 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.
•6. Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after completion of
•Trial 291.
•7. Subjects likely to require prohibited concomitant therapy during the trial
•8. Laboratory test and ECG results which are exclusionary
•9.Any subject who, in the opinion of the investigator or medical monitor, should not participate in

发起方

Otsuka Pharmaceutical Development & Commercialization,