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Completed

NCT Number: NCT03839251

Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry, Inje University Haeundae Paik Hospital, Busan, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

abilify maintena

Drug

aripiprazole 400mg or 300mg, IM, Once a month

Other names: aripiprazole

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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