MAintain the Efficacy and Safety in Treatment of Schizophrenia After Switching to Long-acTing Injectable aRipiprazole From Oral Atypical Antipsychotics
- Conditions
- Long-Acting InjectionLAIAripiprazoleSchizophreniaAntipsychotics
- Interventions
- Registration Number
- NCT03376763
- Lead Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Interventional, multicenter, open-label, 20 weeks study
* To identify efficacy and safety in switching from oral aripiprazole to Abilify Maintena.
* To identify efficacy and safety in switching from oral atypical antipsychotics other than aripiprazole to Abilify Maintena
- Detailed Description
We would like to evaluate the efficacy and safety when switching to Abilify Maintena according to the approved indication of Abilify Maintena, for subjects who are taking oral antipsychotic drugs. It is expected that this will serve as a basis for suggesting a successful switching guideline from oral antipsychotics to Abilify Maintena, which can be applicable in clinical practice.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Abilify maintena Schizophrenia patients who are taking oral aripiprazole will be switched to Abilify maintena Group 2 Abilify maintena Schizophrenia patients who are taking other oral atypical antipsychotics will be switched to Abilify maintena
- Primary Outcome Measures
Name Time Method PANSS total score 16 weeks Change in PANSS total score from baseline to Week 16
- Secondary Outcome Measures
Name Time Method CGI-S 16 weeks Change in CGI-S (severity) from baseline to Week 16
IAQ score 16 weeks Mean IAQ score at Week 16
CGI-I 16 weeks Mean CGI-I (improvement) score at Week 16
PANSS positive and negative subscale score 16 weeks Change in PANSS positive and negative subscale score from baseline to Week 16
Trial Locations
- Locations (27)
Cha Bundang Medical Center
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Chungju Hospital
🇰🇷Chungju, Chungcheongbuk-do, Korea, Republic of
Gongju National Hospital
🇰🇷Gongju, Chungcheongnam-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si,, Gyeonggi-do, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-si, Gyeonggi-do, Korea, Republic of
Yong-In Mental Hospital
🇰🇷Yongin-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea Uijeongbu ST. Mary'S Hospital
🇰🇷Uijeongbu Si, Gyeonggi-do, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju, Jeju-do, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
International St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Pusan, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Eulji General Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hosipital
🇰🇷Seoul, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Pusan, Korea, Republic of