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Trial record 15 of 414 for:    ARIPIPRAZOLE

PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03285503
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Otsuka Beijing Research Institute

Tracking Information
First Submitted Date  ICMJE September 11, 2017
First Posted Date  ICMJE September 18, 2017
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE August 17, 2018
Actual Primary Completion Date October 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • Adverse Events [ Time Frame: up to 24 weeks ]
    Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 14, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Official Title  ICMJE 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
Brief Summary This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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
Study Arms  ICMJE 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).
Intervention: Drug: Aripiprazole IM Depot
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 14, 2019
Actual Primary Completion Date October 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03285503
Other Study ID Numbers  ICMJE 031-403-00049
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Otsuka Beijing Research Institute
Study Sponsor  ICMJE Otsuka Beijing Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tao Jiang, Master Beijing Anding Hospital of Capital Medical University
PRS Account Otsuka Beijing Research Institute
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP