MAintain the Efficacy and Safety in Treatment of Schizophrenia After Switching to Long-acTing Injectable aRipiprazole From Oral Atypical Antipsychotics

Phase 4

Completed

• Conditions: Long-Acting Injection; LAI; Aripiprazole; Schizophrenia; Antipsychotics
• Interventions: Drug: Abilify maintena

• 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.

Study Timeline

• Study Start: 2017-11-21
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-18
• Primary Completion: 2021-11-19
• Study Completion: 2021-11-19
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

Not provided

Exclusion Criteria

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
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
IAQ score	16 weeks	Mean IAQ score at Week 16

Trial Locations

Locations (27)

Konkuk University Chungju Hospital; 🇰🇷 Chungju, Chungcheongbuk-do, Korea, Republic of

Gongju National Hospital; 🇰🇷 Gongju, Chungcheongnam-do, Korea, Republic of

Hanyang University Guri Hospital; 🇰🇷 Guri-si, Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si,, Gyeonggi-do, Korea, Republic of

Cha Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

The Catholic University of Korea Uijeongbu ST. Mary'S Hospital; 🇰🇷 Uijeongbu Si, Gyeonggi-do, Korea, Republic of

Yong-In Mental Hospital; 🇰🇷 Yongin-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

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

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