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

• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03376763
• Collaborator: (none)
• Enrollment: 201
• Locations: 27
• Arms: 2
• Actual Duration (Months): 47.9
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Antipsychotics; Long-Acting Injection; LAI; Aripiprazole	Drug: Abilify maintena	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 201 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MAintain the Efficacy and Safety in Treatment of Schizophrenia After Switching to Long-acTing Injectable aRipiprazole From Oral Atypical Antipsychotics
• Actual Study Start Date: Nov 21, 2017
• Actual Primary Completion Date: Nov 19, 2021
• Actual Study Completion Date: Nov 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Schizophrenia patients who are taking oral aripiprazole will be switched to Abilify maintena	Drug: Abilify maintena; Switching from oral atypical antipsychotics to long-acting injectable aripiprazole (Abilify maintena); Other Names: long-acting injectable aripiprazole
Experimental: Group 2 Schizophrenia patients who are taking other oral atypical antipsychotics will be switched to Abilify maintena	Drug: Abilify maintena; Switching from oral atypical antipsychotics to long-acting injectable aripiprazole (Abilify maintena); Other Names: long-acting injectable aripiprazole

Outcome Measures

Primary Outcome Measures

1. PANSS total score [16 weeks]

   Change in PANSS total score from baseline to Week 16

Secondary Outcome Measures

1. CGI-S [16 weeks]

   Change in CGI-S (severity) from baseline to Week 16

2. CGI-I [16 weeks]

   Mean CGI-I (improvement) score at Week 16

3. PANSS positive and negative subscale score [16 weeks]

   Change in PANSS positive and negative subscale score from baseline to Week 16

4. IAQ score [16 weeks]

   Mean IAQ score at Week 16

Other Outcome Measures

1. study discontinuation rates [16 weeks]

   Comparison the study discontinuation rates between Group 1 and Group 2

2. study discontinuation rates [16 weeks]

   Comparison the study discontinuation rates in Group 2 depending on the other oral atypical antipsychotics

3. proportion of subjects who have more than 20% increased rating on the PANSS total score [16 weeks]

   Comparison the proportion of subjects who have more than 20% increased rating on the PANSS total score from baseline to Week 16 between Group 1and Group 2

4. proportion of subjects who have more than 20% increased rating on the PANSS total score [16 weeks]

   Comparison the proportion of subjects who have more than 20% increased rating on the PANSS total score from baseline to Week 16 in Group 2 depending on the other oral atypical antipsychotics

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

1. Subjects who voluntarily consented to participating in the clinical trial.

2. Male and female legally aged ≥19 and < 65 years.

3. Subjects who were diagnosed of schizophrenia as defined by DSM diagnostic criteria, and were diagnosed of schizophrenia for at least for 2 years prior to screening.

4. Subjects with all of the following schizophrenia clinical features:

1. Outpatient subjects, with no hospitalization for worsening of schizophrenia within 3 months prior to screening.

2. Subjects who have no more than a moderate rating on the PANSS total score≤80 C. 4 individual PANSS items, which are concerning to psychotic symptom (P2. conceptual disorganization, P3. hallucinatory behavior, P6. suspiciousness/persecution, G9. unusual thought content), score≤4.

3. CGI-S score ≤4 (moderately ill).

1. Subjects who take atypical antipsychotic drugs with the therapeutic effective dose (as specified in each label) for schizophrenia treatment, and should be maintained on the type and dose of the current antipsychotic drugs (including both typical and atypical antipsychotic drugs) for at least 4 weeks prior to the screening.

2. Subjects who need antipsychotic treatment (other than clozapine), and would be stable when switching to Abilify Maintena on the investigator's judgement.

3. Subjects must exhibit willingness, physiologic capability, and an educational level sufficient to comply with all protocol procedures as per the investigator's judgment.

Exclusion criteria

1. Subject who showed medically significant adverse events or intolerance with aripiprazole during screening period or as prior experiences.

2. Subjects with a current DSM diagnostic criteria-based diagnosis other than schizophrenia, including Schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, neurocognitive disorder due to Alzheimer's or similar diseases, amnesia, borderline, paranoid, histrionic, schizotypal, schizoid, antisocial or other cognitive or personality disorders.

3. Subjects with diseases of the central nervous system that may impact the assessment of the psychotic symptoms as per investigator's opinion.

4. Subjects who have been treated with clozapine, electroconvulsive therapy (ECT) or other long-acting injectable antipsychotic drugs within 3 months prior to the screening.

5. Subjects who have been treated more than 2 oral antipsychotic drugs (including both typical and atypical antipsychotic drugs) with the minimum therapeutic effective dose (as specified in each label) for schizophrenia treatment at screening.

(e.g. Aripiprazole≥10 mg/day, Olanzapine≥10 mg/day, Risperidone≥2 mg/day, Quetiapine ≥150 mg/day)

1. Subjects who have been treated with oral antipsychotic drugs (including both typical and atypical antipsychotic drugs) exceeding maximum maintenance dose (as specified in each label) at screening.

(e.g. Aripiprazole>30 mg/day, Olanzapine>20 mg/day, Risperidone > 6 mg/day, Quetiapine

750 mg/day)

1. Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.

2. Subjects had a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose them to undue risk or interfere with study assessments.

3. Significant history of drug abuse disorder (excluding caffeine and nicotine, including alcohol, as defined in DSM-5 substance use disorder or in the opinion of the investigator) within the last 6 months prior to screening.

4. Subjects who participated in another interventional clinical trial within 30 days prior to screening.

5. Pregnant or lactating women, or women of childbearing potential who are not willing to or not able to use contraceptive methods (sexual abstinence; oral, implanted or injection hormone contraceptive methods; intrauterine device or condom; barrier contraceptive methods such as diaphragm and spermicide), accepted to avoid pregnancy until the end of the clinical trial.

6. Subjects having any other clinically significant finding of the physical examination or laboratory value that make investigator consider that it would be inappropriate to participate in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Konkuk University Chungju Hospital	Chungju	Chungcheongbuk-do	Korea, Republic of	27376
2	Gongju National Hospital	Gongju	Chungcheongnam-do	Korea, Republic of	32601
3	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do	Korea, Republic of
4	Seoul National University Bundang Hospital	Seongnam-si,	Gyeonggi-do	Korea, Republic of
5	Cha Bundang Medical Center	Seongnam-si	Gyeonggi-do	Korea, Republic of
6	The Catholic University of Korea Uijeongbu ST. Mary'S Hospital	Uijeongbu Si	Gyeonggi-do	Korea, Republic of
7	Yong-In Mental Hospital	Yongin-si	Gyeonggi-do	Korea, Republic of	17089
8	Jeju National University Hospital	Jeju	Jeju-do	Korea, Republic of	63241
9	Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of
10	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
11	Kyungpook National University Hospital	Daegu		Korea, Republic of
12	Yeungnam University Medical Center	Daegu		Korea, Republic of
13	Eulji University Hospital	Daejeon		Korea, Republic of	35233
14	Konyang University Hospital	Daejeon		Korea, Republic of	35365
15	Chungnam National University Hospital	Daejeon		Korea, Republic of
16	Chonnam National University Hospital	Gwangju		Korea, Republic of
17	Inha University Hospital	Incheon		Korea, Republic of	22332
18	International St. Mary's Hospital	Incheon		Korea, Republic of
19	Inje University Haeundae Paik Hospital	Pusan		Korea, Republic of
20	Pusan National University Yangsan Hospital	Pusan		Korea, Republic of
21	Kangbuk Samsung Hospital	Seoul		Korea, Republic of	03181
22	Samsung Medical Center	Seoul		Korea, Republic of	06351
23	Eulji General Hospital	Seoul		Korea, Republic of
24	Ewha Womans University Mokdong Hospital	Seoul		Korea, Republic of
25	Korea University Anam Hospital	Seoul		Korea, Republic of
26	Kyung Hee University Hospital	Seoul		Korea, Republic of
27	Seoul National University Hosipital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Jun Soo Kwon, Dr., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical trial guideline for Antipsychotics; Ministry Food And Drug, 2015.09.
• The survey of Mental Disorders in Korea; Ministry of Health and Welfare, 2016
• Abilify Maintena Package Insert in Korea
• Abilify Package Insert in Korea

Publications

• Aripiprazole Investigator Brochure, Version No. 20, 16 Aug 2016

• Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03376763
• Other Study ID Numbers: 031-402-00129
• First Posted: Dec 18, 2017
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.: aripiprazole; Long-Acting Injection
• Additional relevant MeSH terms: Schizophrenia; Aripiprazole

Study Results

No Results Posted as of Dec 17, 2021