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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: NCT03287505
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : January 17, 2020
Sponsor:
Information provided by (Responsible Party):
Otsuka Beijing Research Institute

Tracking Information
First Submitted Date  ICMJE May 15, 2017
First Posted Date  ICMJE September 19, 2017
Last Update Posted Date January 17, 2020
Actual Study Start Date  ICMJE June 23, 2017
Actual Primary Completion Date July 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03287505 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • 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).
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 20 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 Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Official Title  ICMJE 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
Brief Summary This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel 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 300 and 400mg once in patients with schizophrenia.
Other Name: ABILIFY MAINTENA
Study Arms  ICMJE
  • Experimental: Abilify IM Depot 300mg by once
    300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;
    Intervention: Drug: Aripiprazole IM Depot
  • Experimental: Abilify IM Depot 400mg by once
    400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.
    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)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 12, 2019
Actual Primary Completion Date July 12, 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. 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.

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 NCT03287505
Other Study ID Numbers  ICMJE 031-403-00050
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