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NCT Number: NCT03285503

PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, 100088, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;
  • Subjects who are alcoholomania or independent of drug, or have drug abuse history;
  • Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;

Other protocol-defined inclusion and exclusion criteria may apply.

Treatment and study plan

Aripiprazole IM Depot

Drug

administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.

Other names: ABILIFY MAINTENA

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: up to 24 weeks

    To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.

  2. time of maximum observed plasma concentration (tmax)

    Time frame: up to 24 week

    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.

  3. AUC672h

    Time frame: up to 24 weeks

    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.

  4. Apparent clearance after extravascular administration

    Time frame: up to 24 weeks

    To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.

Secondary outcomes

  1. Adverse Events

    Time frame: up to 24 weeks

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

  2. Vital Signs

    Time frame: up to 24 weeks

    Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs

  3. Laboratory Examination

    Time frame: up to 24 weeks

    Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin)

Other outcomes

  1. Positive and Negative Symptoms Scale (PANSS)

    Time frame: up to 24 weeks

    To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.

Sponsors and collaborators

Lead sponsor

Otsuka Beijing Research Institute

Industry

Registry information

Official study title

A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2017
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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