Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Study Overview
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Brief Summary
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This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.

Detailed Description
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In this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug. In this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleIM Depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.

Official Title
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Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Aripiprazole IM Depot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF); Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60); subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent. Exclusion Criteria: Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR; Score of Positive and Negative Syndrome Scale (PANSS): ≥120; Patients with a complication or a history of diabetic mellitus; Subjects who are alcoholemia overdependent of drug, or have drug abuse history; Other protocol-defined inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abilify IM Depot 300mg by once<br>300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects; | Drug: Aripiprazole IM Depot<br>* administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.<br>* Other names: ABILIFY MAINTENA;|
| Experimental: Abilify IM Depot 400mg by once<br>400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects. | Drug: Aripiprazole IM Depot<br>* administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.<br>* Other names: ABILIFY MAINTENA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration | To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857 | up to 20 weeks | 
| Time of Maximum Concentration | To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857 | up to 20 weeks | 
| AUC0-∞ | To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857 | up to 20 weeks | 
| Apparent clearance after extravascular administration | To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole | up to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment. | up to 20 weeks | 
| Vital Signs | Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs | up to 20 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). | up to 20 weeks |