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SchizophreniaPhase 4MAESTRONCT03376763

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

A Phase 4 study testing Abilify maintena in people with Schizophrenia and Antipsychotics, run by Korea Otsuka Pharmaceutical Co., Ltd. at 27 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 19 to 64 years
What is being tested?
Abilify maintena
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
27 sitesSouth Korea
Study dates
21 Nov 2017to 19 Nov 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

South Korea27 sites

  • Konkuk University Chungju Hospital

    Chungju, North Chungcheong, 27376

  • Keimyung University Dongsan Medical Center

    Daegu

  • Kyungpook National University Hospital

    Daegu

  • Yeungnam University Medical Center

    Daegu

  • Eulji University Hospital

    Daejeon, 35233

  • Konyang University Hospital

    Daejeon, 35365

  • Chungnam National University Hospital

    Daejeon

  • Gongju National Hospital

    Gongju, Chungcheongnam-do, 32601

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do

  • Chonnam National University Hospital

    Gwangju

  • Inha University Hospital

    Incheon, 22332

  • International St. Mary's Hospital

    Incheon

  • Jeju National University Hospital

    Jeju City, Jeju-do, 63241

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do

  • Inje University Haeundae Paik Hospital

    Pusan

  • Pusan National University Yangsan Hospital

    Pusan

  • Cha Bundang Medical Center

    Seongnam-si, Gyeonggi-do

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Samsung Medical Center

    Seoul, 06351

  • Eulji General Hospital

    Seoul

  • Ewha Womans University Mokdong Hospital

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Kyung Hee University Hospital

    Seoul

  • Seoul National University Hosipital

    Seoul

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

    Uijeongbu-si, Gyeonggi-do

  • Yong-In Mental Hospital

    Yongin-si, Gyeonggi-do, 17089

Other trials in South Korea

About this study

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
Read the 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.

Being tested
Abilify maintena
Keywords
aripiprazole, Long-Acting Injection
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abilify maintenaDrug

    Also called long-acting injectable aripiprazole

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

Study groups in NCT03376763
Study groupRoleWhat they receive
Group 1ExperimentalSchizophrenia patients who are taking oral aripiprazole will be switched to Abilify maintena
Receives: Drug: Abilify maintena
Group 2ExperimentalSchizophrenia patients who are taking other oral atypical antipsychotics will be switched to Abilify maintena
Receives: Drug: Abilify maintena

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PANSS total score

    Change in PANSS total score from baseline to Week 16

    Measured: 16 weeks

Secondary outcomes (4)

  1. CGI-S

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

    Measured: 16 weeks

  2. CGI-I

    Mean CGI-I (improvement) score at Week 16

    Measured: 16 weeks

  3. PANSS positive and negative subscale score

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

    Measured: 16 weeks

  4. IAQ score

    Mean IAQ score at Week 16

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2017
  2. Study start21 Nov 2017
  3. Primary completion19 Nov 2021
  4. Study completion19 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03376763
Sponsor's protocol ID
031-402-00129
Acronym
MAESTRO
Status last verified
Dec 2021
First submitted
13 Dec 2017
Last updated
17 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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

  • 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.

    PubMed 8427558

  • 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.

    PubMed 7872841

  • 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.

    PubMed 11691689

  • 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.

    PubMed 22697189

  • 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.

    PubMed 26232241

  • 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.

    PubMed 24925984

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abilify maintena in people with Schizophrenia and Antipsychotics, run by Korea Otsuka Pharmaceutical Co., Ltd. at 27 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PANSS total score (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03376763, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.

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