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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)

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ClinicalTrials.gov Identifier: NCT03376763
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 26, 2017
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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



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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 must be capable of providing signed and dated written informed consent by date of Visit 0 (-2 week).
  2. Male and female aged ≥19 and < 65 years.
  3. Subjects diagnosed of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision or 5th edition (DSM-Ⅳ-TR or 5) criteria, and a history of illness for at least for 3 years prior to screening.
  4. Subjects with all of the following schizophrenia clinical features:

    A. Outpatient, 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 Positive and Negative Syndrome Scale (PANSS) total score≤80 C. 4 individual PANSS items which are concerning to psychotic symptom (P2.conceptual disorganization, P3.hallucinatory behaviour, P6. suspiciousness or G9. unusual thought content). score≤4.

    D. Clinical Global Impressions-Severity of Illness (CGI-S) score ≤4 (moderately ill).

  5. Subjects who take atypical antipsychotic drugs, and should be maintained on current antipsychotic drugs (including atypical antipsychotic drugs) and dose 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 long-acting injectable aripiprazole in the investigator's judgement.
  7. Subjects must exhibit willingness, physiologic capability, and an educational level sufficient to comply with all protocol procedures.

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-Ⅳ-TR or 5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, 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 or long-acting injectable antipsychotic drugs within 3 months prior to the screening.
  5. Subjects who have been treated more than 2 oral antipsychotic drugs with the maintenance dose (as specified in each label) for schizophrenia treatment at screening.

    (e.g. Aripiprazole≥10mg/day, Olanzapine≥10mg/day, Risperidone≥2mg/day, Quetiapine ≥150mg/day))

  6. Subjects who have been treated over maximum maintenance dose (as specified in each label) of oral antipsychotics at screening. (e.g. Aripiprazole>30mg/day, Olanzapine>20mg/day, Risperidone > 6mg/day, Quetiapine > 750mg/day)
  7. Subjects with a significant risk of violent behaviour 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 (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 participating another interventional clinical trial within 30 days prior to screening.
  11. Women who are pregnant, nursing, or who plan to become pregnant while in the 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


Contacts
Contact: Heesu Kim +82-2-3287-9126 heesukim@otsuka.co.kr
Contact: Hae Eun Park +82-2-3287-9277 hpark1116@otsuka.co.kr

Locations
Korea, Republic of
Hanyang University Guri Hospital Recruiting
Guri-si, Gyeonggi-do, Korea, Republic of
Contact: Joon Ho Choi, Dr.    031-560-2272    jchoi@hanyang.ac.kr   
Seoul National University Bundang Hospital Recruiting
Seongnam-si,, Gyeonggi-do, Korea, Republic of
Contact: Eui Tae Kim, Dr.    031-787-7435    euitae.kim@gmail.com   
Cha Bundang Medical Center Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of
Contact: Tai Kiu Choi, Dr.    031-780-5874    ctk7089@hanmail.net   
The Catholic University of Korea Uijeongbu ST. Mary'S Hospital Recruiting
Uijeongbu Si, Gyeonggi-do, Korea, Republic of
Contact: Kyoung Uk Lee, Dr.    031-820-3609    mindcure@catholic.ac.kr   
Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of
Contact: Young Chul Chung, Dr.    063-250-2185    chungyc@jbnu.ac.kr   
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Sung Won Jung, Dr.    053-250-8173    Swon12@daum.net   
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Seung Hee Won, Dr.    053-420-5751    wonsh864@gmail.com   
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Ik Seong Chee, Dr.    042-280-7291    ischee@cnu.ac.kr   
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Sung Wan Kim, Dr.    062-220-6148    shalompsy@hanmail.net   
Inje University Haeundae Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: Bong Ju Lee, Dr.    051-797-3305    bongjulee@empal.com   
Pusan National University Yangsan Hospital Recruiting
Pusan, Korea, Republic of
Contact: Sung Gon Kim, Dr.    055-360-1480    sungkim@pusan.ac.kr   
Eulji General Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyu Young Lee, Dr.    02-970-8604    lky@eulji.ac.kr   
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of
Contact: Soo In Kim, Dr.    02-2650-2821    72sooik@ewha.ac.kr   
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Heon Jeong Lee, Dr.    02-920-6721    leehjeong@korea.ac.kr   
Seoul National University Hosipital Recruiting
Seoul, Korea, Republic of
Contact: Jun Soo Kwon, Dr.    +82-2-2072-2972    kwonjs@snu.ac.kr   
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
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

Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03376763     History of Changes
Other Study ID Numbers: 031-402-00129
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs