Aripiprazole IM Depot for Chinese Patients With Schizophrenia

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 8, 2019

Detailed Description

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Abilify IM Depot 300mg by once
    • 300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;
  • Experimental: Abilify IM Depot 400mg by once
    • 400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Adverse Events
    • Time Frame: up to 20 weeks
    • Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.
  • Vital Signs
    • Time Frame: up to 20 weeks
    • Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs
  • Laboratory Examination
    • Time Frame: up to 20 weeks
    • Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Otsuka Beijing Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tao Jiang, Master, Principal Investigator, Beijing Anding Hospital of Capital Medical University

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