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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: abilify maintena

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Department of Psychiatry, Inje University Haeundae Paik Hospital
  • Daegu, Korea, Republic of
    • Department of Psychiatry, Kyungpook National University Hospital
  • Daegu, Korea, Republic of
    • Department of Psychiatry, Yeungnam University Medical Center
  • Gwangju, Korea, Republic of
    • Department of Psychiatry, Chonnam National University Medical School
  • Jeonju, Korea, Republic of
    • Department of Psychiatry, Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: abilify maintena; aripiprazole 400mg or 300mg, IM, Once a month	Drug: abilify maintena; aripiprazole 400mg or 300mg, IM, Once a month; Other Names: aripiprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline PSP(Personal and Social Performance scale) at 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.	12weeks
Change from Baseline PSP(Personal and Social Performance scale) at 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.	24weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)	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.	baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks
Efficacy Assessment by ERT(Emotional Recognition Test)	Emotional Recognition Test(ERT) minimum of ERT(Emotional Recognition Test) total score is 0, Maximum is 54. The lower number is worse outcome.	baseline, 24weeks
Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)	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.	baseline, 12weeks, 24weeks
Efficacy Assessment by self rating scale	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.	baseline, 12weeks, 24weeks
Safety Assessment by Simpson-Angus Scale(SAS)	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.	baseline, 12weeks, 24weeks
Safety Assessment by Barnes Akathisia Rating Scale(BARS)	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.	baseline, 12weeks, 24weeks
Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)	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.	baseline, 12weeks, 24weeks
Safety Assessment by self report scale	Visual Analogue Scale(VAS) minimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome.	baseline, 12weeks, 24weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Collaborators: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): January 22, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 10, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: aripiprazole; long-acting injection
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: CUH 2018-02-011-005

Drug and device information, study documents

• 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