Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Otsuka Beijing Research Institute24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

Aripiprazole IM DepotDRUG

administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF); 2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60); 3. 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: 1. Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR; 2. Score of Positive and Negative Syndrome Scale (PANSS): ≥120; 3. Patients with a complication or a history of diabetic mellitus; 4. Subjects who are alcoholemia overdependent of drug, or have drug abuse history; Other protocol-defined inclusion and exclusion criteria may apply.

Locations (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Maximum Plasma Concentration

To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857

Time frame: up to 20 weeks

Time of Maximum Concentration

To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857

Time frame: 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

Time frame: up to 20 weeks

Apparent clearance after extravascular administration

To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole

Time frame: up to 20 weeks

Secondary Outcomes

Adverse Events

Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.

Time frame: 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

Time frame: 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).

Time frame: up to 20 weeks

Data from ClinicalTrials.gov

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