Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287505
Recruitment Status : Recruiting
First Posted : September 19, 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 single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.

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

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : June 23, 2017
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: Abilify IM Depot 300mg by once
300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;
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

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




Primary Outcome Measures :
  1. Maximum Plasma Concentration [ Time Frame: up to 20 weeks ]
    To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857

  2. 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

  3. 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

  4. Apparent clearance after extravascular administration [ Time Frame: up to 20 weeks ]
    To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: up to 20 weeks ]
    Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.

  2. 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

  3. 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).


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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. 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.


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): NCT03287505


Contacts
Layout table for location contacts
Contact: Wenwen Xu, Master 010-85182966 ext 8035 xuww@obri.otsuka.com

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Tao Jiang, Master Beijing Anding Hospital of Capital Medical University

Layout table for additonal information
Responsible Party: Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT03287505     History of Changes
Other Study ID Numbers: 031-403-00050
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
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