MAintain the Efficacy and Safety in Treatment of Schizophrenia After Switching to Long-acTing Injectable aRipiprazole From Oral Atypical Antipsychotics
Overview
- Phase
- Phase 4
- Intervention
- Abilify maintena
- Conditions
- Schizophrenia
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Enrollment
- 201
- Locations
- 27
- Primary Endpoint
- PANSS total score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
Schizophrenia patients who are taking oral aripiprazole will be switched to Abilify maintena
Intervention: Abilify maintena
Group 2
Schizophrenia patients who are taking other oral atypical antipsychotics will be switched to Abilify maintena
Intervention: Abilify maintena
Outcomes
Primary Outcomes
PANSS total score
Time Frame: 16 weeks
Change in PANSS total score from baseline to Week 16
Secondary Outcomes
- CGI-S(16 weeks)
- CGI-I(16 weeks)
- PANSS positive and negative subscale score(16 weeks)
- IAQ score(16 weeks)