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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2021-11-19

Brief Summary

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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

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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.

Conditions

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Schizophrenia Antipsychotics Long-Acting Injection LAI Aripiprazole

Keywords

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aripiprazole Long-Acting Injection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Schizophrenia patients who are taking oral aripiprazole will be switched to Abilify maintena

Group Type EXPERIMENTAL

Abilify maintena

Intervention Type DRUG

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

Group 2

Schizophrenia patients who are taking other oral atypical antipsychotics will be switched to Abilify maintena

Group Type EXPERIMENTAL

Abilify maintena

Intervention Type DRUG

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

Interventions

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Abilify maintena

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

Intervention Type DRUG

Other Intervention Names

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long-acting injectable aripiprazole

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Soo Kwon, Dr.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

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South Korea

References

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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-controlled study. J Clin Psychiatry. 2012 May;73(5):617-24. doi: 10.4088/JCP.11m07530.

Reference Type RESULT

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Group 1

Abilify maintena

Group 2

Abilify maintena

Interventions

Abilify maintena

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

Responsible Party

Principal Investigators

Jun Soo Kwon, Dr.

Locations

Gongju National Hospital

Hanyang University Guri Hospital

Cha Bundang Medical Center

Seoul National University Bundang Hospital

The Catholic University of Korea Uijeongbu ST. Mary'S Hospital

Yong-In Mental Hospital

Jeju National University Hospital

Chonbuk National University Hospital

Konkuk University Chungju Hospital

Keimyung University Dongsan Medical Center

Kyungpook National University Hospital

Yeungnam University Medical Center

Eulji University Hospital

Konyang University Hospital

Chungnam National University Hospital

Chonnam National University Hospital

Inha University Hospital

International St. Mary's Hospital

Inje University Haeundae Paik Hospital

Pusan National University Yangsan Hospital

Kangbuk Samsung Hospital

Samsung Medical Center

Eulji General Hospital

Ewha Womans University Mokdong Hospital

Korea University Anam Hospital

Kyung Hee University Hospital

Seoul National University Hosipital

Countries

References

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

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

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. doi: 10.1001/archpsyc.1995.03950150005001. No abstract available.

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. doi: 10.1176/appi.ajp.158.11.1835.

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

Related Links

Other Identifiers

031-402-00129