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

NCT03839251 | Completed Phase 4

• 1 other identifier: CUH 2018-02-011-005
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Schizophrenia

Keywords

aripiprazole; long-acting injection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)

  baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks

• Efficacy Assessment by ERT(Emotional Recognition Test)

  baseline, 24weeks

• Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)

  baseline, 12weeks, 24weeks

• Efficacy Assessment by self rating scale

  baseline, 12weeks, 24weeks

• Safety Assessment by Simpson-Angus Scale(SAS)

  baseline, 12weeks, 24weeks

Study Arms (1)

abilify maintena

OTHER

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

Drug: abilify maintena

Interventions

abilify maintena DRUG

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

Also known as: aripiprazole

abilify maintena

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (5)

Department of Psychiatry, Inje University Haeundae Paik Hospital

Busan, South Korea

Location

Department of Psychiatry, Kyungpook National University Hospital

Daegu, South Korea

Location

Department of Psychiatry, Yeungnam University Medical Center

Daegu, South Korea

Location

Department of Psychiatry, Chonnam National University Medical School

Gwangju, South Korea

Location

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Young-chul Chung, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 15, 2019
• Study Start: June 1, 2018
• Primary Completion: January 22, 2020
• Study Completion: September 30, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

KR (5)