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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376763
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Antipsychotics Long-Acting Injection LAI Aripiprazole Drug: Abilify maintena Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MAintain the Efficacy and Safety in Treatment of Schizophrenia After Switching to Long-acTing Injectable aRipiprazole From Oral Atypical Antipsychotics
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : November 19, 2021
Actual Study Completion Date : November 19, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Group 1
Schizophrenia patients who are taking oral aripiprazole will be switched to Abilify maintena
Drug: Abilify maintena
Switching from oral atypical antipsychotics to long-acting injectable aripiprazole (Abilify maintena)
Other Name: long-acting injectable aripiprazole

Experimental: Group 2
Schizophrenia patients who are taking other oral atypical antipsychotics will be switched to Abilify maintena
Drug: Abilify maintena
Switching from oral atypical antipsychotics to long-acting injectable aripiprazole (Abilify maintena)
Other Name: long-acting injectable aripiprazole




Primary Outcome Measures :
  1. PANSS total score [ Time Frame: 16 weeks ]
    Change in PANSS total score from baseline to Week 16


Secondary Outcome Measures :
  1. CGI-S [ Time Frame: 16 weeks ]
    Change in CGI-S (severity) from baseline to Week 16

  2. CGI-I [ Time Frame: 16 weeks ]
    Mean CGI-I (improvement) score at Week 16

  3. PANSS positive and negative subscale score [ Time Frame: 16 weeks ]
    Change in PANSS positive and negative subscale score from baseline to Week 16

  4. IAQ score [ Time Frame: 16 weeks ]
    Mean IAQ score at Week 16


Other Outcome Measures:
  1. study discontinuation rates [ Time Frame: 16 weeks ]
    Comparison the study discontinuation rates between Group 1 and Group 2

  2. study discontinuation rates [ Time Frame: 16 weeks ]
    Comparison the study discontinuation rates in Group 2 depending on the other oral atypical antipsychotics

  3. proportion of subjects who have more than 20% increased rating on the PANSS total score [ Time Frame: 16 weeks ]
    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

  4. proportion of subjects who have more than 20% increased rating on the PANSS total score [ Time Frame: 16 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376763


Locations
Show Show 27 study locations
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Jun Soo Kwon, Dr. Seoul National University Hospital
Additional Information:
Publications of Results:
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
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

Other Publications:
Aripiprazole Investigator Brochure, Version No. 20, 16 Aug 2016

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Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03376763    
Other Study ID Numbers: 031-402-00129
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.:
aripiprazole
Long-Acting Injection
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists