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

NCT03376763 | Completed Phase 4

• 1 other identifier: 031-402-00129
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 27

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

Conditions

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

Keywords

aripiprazole; Long-Acting Injection

Outcome Measures

Primary Outcomes (1)

• PANSS total score

  Change in PANSS total score from baseline to Week 16

  16 weeks

Secondary Outcomes (4)

• CGI-S

  16 weeks

• CGI-I

  16 weeks

• PANSS positive and negative subscale score

  16 weeks

• IAQ score

  16 weeks

Other Outcomes (4)

• study discontinuation rates

  16 weeks

• study discontinuation rates

  16 weeks

• proportion of subjects who have more than 20% increased rating on the PANSS total score

  16 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Abilify maintena

Group 2

EXPERIMENTAL

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

Drug: Abilify maintena

Interventions

Abilify maintena DRUG

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

Also known as: long-acting injectable aripiprazole

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who voluntarily consented to participating in the clinical trial.
• Male and female legally aged ≥19 and \< 65 years.
• 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.
• 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).
• 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.
• Subjects who need antipsychotic treatment (other than clozapine), and would be stable when switching to Abilify Maintena on the investigator's judgement.
• Subjects must exhibit willingness, physiologic capability, and an educational level sufficient to comply with all protocol procedures as per the investigator's judgment.

You may not qualify if:

• Subject who showed medically significant adverse events or intolerance with aripiprazole during screening period or as prior experiences.
• 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.
• Subjects with diseases of the central nervous system that may impact the assessment of the psychotic symptoms as per investigator's opinion.
• Subjects who have been treated with clozapine, electroconvulsive therapy (ECT) or other long-acting injectable antipsychotic drugs within 3 months prior to the screening.
• 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)
• 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)
• Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
• 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.
• 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.
• Subjects who participated in another interventional clinical trial within 30 days prior to screening.
• 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.
• 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.

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (27)

Gongju National Hospital

Gongju, Chungcheongnam-do, 32601, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Location

Cha Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

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

Uijeongbu-si, Gyeonggi-do, South Korea

Location

Yong-In Mental Hospital

Yongin-si, Gyeonggi-do, 17089, South Korea

Location

Jeju National University Hospital

Jeju City, Jeju-do, 63241, South Korea

Location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

Konkuk University Chungju Hospital

Chungju, North Chungcheong, 27376, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Eulji University Hospital

Daejeon, 35233, South Korea

Location

Konyang University Hospital

Daejeon, 35365, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

International St. Mary's Hospital

Incheon, South Korea

Location

Inje University Haeundae Paik Hospital

Pusan, South Korea

Location

Pusan National University Yangsan Hospital

Pusan, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Eulji General Hospital

Seoul, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Seoul National University Hosipital

Seoul, South Korea

Location

Related Publications (10)

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

  BACKGROUND

• 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;50(2):85-94. doi: 10.1001/archpsyc.1993.01820140007001.

  PMID: 8427558 RESULT

• 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

  RESULT

• 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

  RESULT

• 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.

  PMID: 7872841 RESULT

• 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.

  PMID: 11691689 RESULT

• 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.

  PMID: 22697189 RESULT

• 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.

  PMID: 26232241 RESULT

• 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

  RESULT

• 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.

  PMID: 24925984 RESULT

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jun Soo Kwon, Dr.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: November 21, 2017
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

KR (27)