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PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT03285503
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Beijing Research Institute

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole IM Depot Phase 1

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : August 17, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 400 mg group
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.
Other Name: ABILIFY MAINTENA




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Other protocol-defined inclusion and exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285503


Contacts
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Contact: Wenwen Xu, Master 010-85182966 ext 8035 xuww@obri.otsuka.com

Locations
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China, Beijing
Beijing Anding Hospital of Capital Medical University Recruiting
Beijing, Beijing, China, 100088
Contact: Tao Jiang, Master    010-58303122    xinlingfangke01@126.com   
Sponsors and Collaborators
Otsuka Beijing Research Institute
Investigators
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Principal Investigator: Tao Jiang, Master Beijing Anding Hospital of Capital Medical University

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Responsible Party: Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT03285503     History of Changes
Other Study ID Numbers: 031-403-00049
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aripiprazole
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists