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Trial record 1 of 408 for:    ARIPIPRAZOLE
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Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients

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ClinicalTrials.gov Identifier: NCT03839251
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Young Chul Chung, Chonbuk National University Hospital

Brief Summary:
The aim of the study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: abilify maintena Phase 4

Detailed Description:
The aim of this study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
abilify maintena
aripiprazole 400mg or 300mg, IM, Once a month
Drug: abilify maintena
aripiprazole 400mg or 300mg, IM, Once a month
Other Name: aripiprazole




Primary Outcome Measures :
  1. Change from Baseline PSP(Personal and Social Performance scale) at 12weeks [ Time Frame: 12weeks ]
    PSP(Personal and Social Performance scale) was measured in baseline and 12week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.

  2. Change from Baseline PSP(Personal and Social Performance scale) at 24weeks [ Time Frame: 24weeks ]
    PSP(Personal and Social Performance scale) was measured in baseline and 24week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.


Secondary Outcome Measures :
  1. Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia) [ Time Frame: baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks ]

    Clinical global impression-schizophrenia(CGI-S)

    There are Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity in the Clinical global impression-schizophrenia(CGI-S). minimum of each items(Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity) is 1, Maximum is 7. The higher number is worse outcome.


  2. Efficacy Assessment by ERT(Emotional Recognition Test) [ Time Frame: baseline, 24weeks ]

    Emotional Recognition Test(ERT)

    minimum of ERT(Emotional Recognition Test) total score is 0, Maximum is 54. The lower number is worse outcome.


  3. Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale) [ Time Frame: baseline, 12weeks, 24weeks ]

    Positive and Negative Syndrome Scale(PANSS)

    There are Positive Scale, Negative Scale and General Psychopathology Scale in the PANSS(Positive and Negative Syndrome Scale). minimum of each items(Positive Scale, Negative Scale and General Psychopathology Scale) is 1, Maximum is 7. The higher number is worse outcome.


  4. Efficacy Assessment by self rating scale [ Time Frame: baseline, 12weeks, 24weeks ]

    Subjective Wellbeing under Neuroleptics(SWN-K)

    SWN-K(Subjective Wellbeing under Neuroleptics) consists of 20 questions. The minimum score for each question is zero and the maximum score is five. The reverse scoring questions include 1,4,6,9,10,11,12,14,16,17. The total score of the whole item is obtained, and the lower the score, the worse the subjective well-being.


  5. Safety Assessment by Simpson-Angus Scale(SAS) [ Time Frame: baseline, 12weeks, 24weeks ]

    Simpson-Angus Scale(SAS)

    minimum of each items(Gait, Arm Dropping, Shoulder Shaking, Elbow Rigidity, Fixation of Position or Wrist Rigidity, Leg Pendulousness, Head Dropping, Glabella Tap, Tremor, Salivation) in the SAS(Simpson-Angus Scale) is 0, Maximum is 4. minimum of total scores in the SAS(Simpson-Angus Scale) is 0, Maximum is 40. The higher number is worse outcome.


  6. Safety Assessment by Barnes Akathisia Rating Scale(BARS) [ Time Frame: baseline, 12weeks, 24weeks ]

    Barnes Akathisia Rating Scale(BARS)

    minimum of each items(Objective, Subjective, Distress related to restlessness) in the BAS(Barnes Akathisia Rating Scale) is 0, Maximum is 3. Minimum of Global clinical assessment of akathisia in the BARS is 0, Maximum is 5. The higher number is worse outcome.


  7. Safety Assessment by Abnormal Involuntary Movement Scale(AIMS) [ Time Frame: baseline, 12weeks, 24weeks ]

    Abnormal Involuntary Movement Scale(AIMS)

    minimum of each items in the AIMS(Abnormal Involuntary Movement Scale) is 0, Maximum is 4. The higher number is worse outcome.


  8. Safety Assessment by self report scale [ Time Frame: baseline, 12weeks, 24weeks ]

    Visual Analogue Scale(VAS)

    minimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome.




Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with schizophrenia according to DSM-5 diagnostic standards
  • men and women aged 19 and under 60
  • a person who is being given an atypical antipsychotic.
  • Patients should be able to reasonably cooperate with the questionnaire to be used for the study
  • a person who fully understands the purpose of the study and signs the consent
  • stable outpatient before screening without changing the volume of antipsychotics for at least two weeks

Exclusion Criteria:

  • a person who has a serious and unstable physical condition either now or in the past
  • A fertile woman who is currently pregnant or breastfeeding, or who is either unwilling or unable to use acceptable contraception until the clinical trial is complete.
  • a person suffering from severe drug allergies or complex and severe drug reactions
  • Patients who have taken clozapine in the last 60 days
  • subjects showing significant risk of suicide or significant risk of violent behavior based on past history or investigator's judgment

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): NCT03839251


Contacts
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Contact: Young-chul Chung, MD 82 63 250 2185 chungyc@jbnu.ac.kr

Locations
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Korea, Republic of
Department of Psychiatry, Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Hyun Joo Lee    82 10 9317 0005      
Sub-Investigator: Bong Ju Lee, MD         
Department of Psychiatry, Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Hye Jin Lee    82 10 9216 8626      
Sub-Investigator: Seung Hee Won, MD         
Department of Psychiatry, Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Myo Sun Kim    82 53 624 8353      
Sub-Investigator: Eun Jin Chun, MD         
Department of Psychiatry, Chonnam National University Medical School Recruiting
Gwangju, Korea, Republic of
Contact: Ahn Na Cho    82 10 5661 9694      
Sub-Investigator: Sung Wan Kim, MD         
Department of Psychiatry, Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Lee Na Kim    82 10 7112 1894      
Principal Investigator: Young Chul Chung, MD         
Sponsors and Collaborators
Chonbuk National University Hospital
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Young-chul Chung, MD Chonbuk National University Hospital

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Responsible Party: Young Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03839251     History of Changes
Other Study ID Numbers: CUH 2018-02-011-005
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Young Chul Chung, Chonbuk National University Hospital:
aripiprazole
long-acting injection
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