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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 19, 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Group 1
    • Schizophrenia patients who are taking oral aripiprazole will be switched to Abilify maintena
  • Experimental: Group 2
    • Schizophrenia patients who are taking other oral atypical antipsychotics will be switched to Abilify maintena

Clinical Trial Outcome Measures

Primary Measures

  • PANSS total score
    • Time Frame: 16 weeks
    • Change in PANSS total score from baseline to Week 16

Secondary Measures

  • CGI-S
    • Time Frame: 16 weeks
    • Change in CGI-S (severity) from baseline to Week 16
  • CGI-I
    • Time Frame: 16 weeks
    • Mean CGI-I (improvement) score at Week 16
  • PANSS positive and negative subscale score
    • Time Frame: 16 weeks
    • Change in PANSS positive and negative subscale score from baseline to Week 16
  • IAQ score
    • Time Frame: 16 weeks
    • Mean IAQ score at Week 16

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Korea Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jun Soo Kwon, Dr., Principal Investigator, Seoul National University Hospital

References

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

Citations Reporting on Results

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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.

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.

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 treatment of schizophrenia. Schizophr Res. 2015 Oct;168(1-2):498-504. doi: 10.1016/j.schres.2015.07.007. Epub 2015 Jul 29.

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

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 Psychiatry. 2014 Aug;205(2):135-44. doi: 10.1192/bjp.bp.113.134213. Epub 2014 Jun 12.

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