A Phase 1 interventional study of Aripiprazole IM Depot in Schizophrenia, sponsored by Otsuka Beijing Research Institute. Completed at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-07-10.
Sponsored by Otsuka Beijing Research Institute · Phase 1, Interventional, and Other
This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply.
Aripiprazole IM depot 400mg will be administered every four weeks for 20 weeks after drug switch / steady dose of oral aripiprazole tablets (each subject will receive 5 intramuscular injections totally).
Drug: Aripiprazole IM Depot
administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.
Also known as: ABILIFY MAINTENA
Maximum Plasma Concentration (Cmax)
To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
Time frame: up to 24 weeks
time of maximum observed plasma concentration (tmax)
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
Time frame: up to 24 week
AUC672h
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
Time frame: up to 24 weeks
Apparent clearance after extravascular administration
To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.
Time frame: up to 24 weeks
Adverse Events
Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment
Time frame: up to 24 weeks
Vital Signs
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs
Time frame: up to 24 weeks
Laboratory Examination
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin)
Time frame: up to 24 weeks
Positive and Negative Symptoms Scale (PANSS)
To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.
Time frame: up to 24 weeks
Plan to share: Undecided
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Otsuka Beijing Research Institute