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

Schizophrenia Clinical Trial

— MAESTRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376763
• Other study ID #: 031-402-00129
• Status: Completed
• Phase: Phase 4
• Start date: November 21, 2017
• Est. completion date: November 19, 2021

Study information

• Verified date: December 2021
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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:

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

B. 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.

D. CGI-S score =4 (moderately ill).

5. 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.

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

7. 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)

6. 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)

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

8. 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.

9. 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.

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

11. 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.

12. 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.

Related Conditions & MeSH terms

• Antipsychotics
• Aripiprazole
• LAI
• Long-Acting Injection
• Schizophrenia

Intervention

Drug:
• Abilify maintena
Switching from oral atypical antipsychotics to long-acting injectable aripiprazole (Abilify maintena)

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Chungju Hospital	Chungju	Chungcheongbuk-do
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Gongju National Hospital	Gongju	Chungcheongnam-do
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
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	Jeju National University Hospital	Jeju	Jeju-do
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-do
Korea, Republic of	Inje University Haeundae Paik Hospital	Pusan
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Cha Bundang Medical Center	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si,	Gyeonggi-do
Korea, Republic of	Eulji General Hospital	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hosipital	Seoul
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

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

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

Fleischhacker WW, Sanchez R, Perry PP, Jin N, Peters-Strickland T, Johnson BR, Baker RA, Eramo A, McQuade RD, Carson WH, Walling D, Kane JM. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. Br J Ps — View Citation

Gilbert PL, Harris MJ, McAdams LA, Jeste DV. Neuroleptic withdrawal in schizophrenic patients. A review of the literature. Arch Gen Psychiatry. 1995 Mar;52(3):173-88. — View Citation

Gitlin M, Nuechterlein K, Subotnik KL, Ventura J, Mintz J, Fogelson DL, Bartzokis G, Aravagiri M. Clinical outcome following neuroleptic discontinuation in patients with remitted recent-onset schizophrenia. Am J Psychiatry. 2001 Nov;158(11):1835-42. — View Citation

Hong Kyu Ihm et al. Factors Related to Medication Adherence in Outpatients with Schizophrenia under More Than 5 Years of Treatment. J Korean Neuropsychiatr Assoc 2016; 55(4):397-406

Hyun-Ku Kang, et al. Safety and Effectiveness of Long Acting Injectable Antipsychotic Paliperidone Palmitate Treatment in Schizophrenics: A 24-Week Open-Label Study. Korean J Biol Psychiatry 2013;20:111-117

Kane JM, Sanchez R, Perry PP, Jin N, Johnson BR, Forbes RA, McQuade RD, Carson WH, Fleischhacker WW. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-contro — View Citation

Naber D, Hansen K, Forray C, Baker RA, Sapin C, Beillat M, Peters-Strickland T, Nylander AG, Hertel P, Andersen HS, Eramo A, Loze JY, Potkin SG. Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatm — View Citation

Regier DA, Narrow WE, Rae DS, Manderscheid RW, Locke BZ, Goodwin FK. The de facto US mental and addictive disorders service system. Epidemiologic catchment area prospective 1-year prevalence rates of disorders and services. Arch Gen Psychiatry. 1993 Feb;5 — View Citation

Seockhoon Chung, Chang Yoon Kim. et al. Effectiveness and Tolerability of Long-Acting Risperidone:A 12 Weeks, Multi-center Switching Study from Oral Antipsychotics. Korean J Psychopharmacol 16/2:109-120, 2005

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	study discontinuation rates	Comparison the study discontinuation rates between Group 1 and Group 2	16 weeks
Other	study discontinuation rates	Comparison the study discontinuation rates in Group 2 depending on the other oral atypical antipsychotics	16 weeks
Other	proportion of subjects who have more than 20% increased rating on the PANSS total score	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	16 weeks
Other	proportion of subjects who have more than 20% increased rating on the PANSS total score	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	16 weeks
Primary	PANSS total score	Change in PANSS total score from baseline to Week 16	16 weeks
Secondary	CGI-S	Change in CGI-S (severity) from baseline to Week 16	16 weeks
Secondary	CGI-I	Mean CGI-I (improvement) score at Week 16	16 weeks
Secondary	PANSS positive and negative subscale score	Change in PANSS positive and negative subscale score from baseline to Week 16	16 weeks
Secondary	IAQ score	Mean IAQ score at Week 16	16 weeks

External Links

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