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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839251
• Other study ID #: CUH 2018-02-011-005
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2021
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 30, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• abilify maintena
aripiprazole 400mg or 300mg, IM, Once a month

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Chonbuk National University Hospital	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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