UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043576 |
|---|---|
| Receipt number | R000043020 |
| Scientific Title | Effect brexpiprazole augmentation for aripiprazole one-monthly on cognitive functioning in Japanese schizophrenia: A Randomized Controlled Clinical Trial |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/09/01 18:04:32 |
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Basic information
Public title
Effect brexpiprazole augmentation for aripiprazole one-monthly on cognitive functioning in Japanese schizophrenia: A Randomized Controlled Clinical Trial
Acronym
BREATH-JM
Scientific Title
Effect brexpiprazole augmentation for aripiprazole one-monthly on cognitive functioning in Japanese schizophrenia: A Randomized Controlled Clinical Trial
Scientific Title:Acronym
BREATH-JM
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of brexpiprazole augmentation on cognitive function in Japanese patients with schizophrenia receiving aripiprazole once-monthly
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Brief Assessment of Cognition in Schizophrenia (BACS) composite scores from week 0 to week 24
Key secondary outcomes
Remission rate, Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity scale (CGI-S), Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS), UKU Side Effect Scale(UKU), Barnes Akathisia Rating Scale (BARS), Epworth Sleepness Scale(ESS), body weight, Body Mass Index, blood biochemistry, Japanese Adult Reading Test (JART), electroencephalography
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aripiprazole once-monthly will be maintained at the same dose as baseline for 24 weeks.
Interventions/Control_2
Brexpiprazole will be augmented with aripiprazole once-monthly for 24 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients having a diagnose of schizophrenia or schizoaffective disorder according to ICD-10
Patients who have not been hospitalized in a psychiatric unit in the past 6 months
Baseline total score 120 or less on the PANSS total score
Having regularly and consecutively received aripiprazole once-monthly for at least 2 months
Having provided written informed consent
Key exclusion criteria
Serious complication
Active suicidal ideations or past suicide attempts
Drug or alcohol abuse
Pregnant or breast-feeding females
mental retardation
Using of oral aripiprazole or asenapine, blonanserin
Having been judged as unsuitable for the study forin other reasons by an principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiteru |
| Middle name | |
| Last name | Takekita |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
570-8506
Address
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
TEL
0669921001
takekity@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiteru |
| Middle name | |
| Last name | Takekita |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
570-8506
Address
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
TEL
0669921001
Homepage URL
takekity@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Neuropsychiatry, Kansai Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board in Kansai Medical University
Address
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
Tel
0669921001
rinriirb@hirakata.kmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
関西医科大学総合医療センター（大阪府）、セフィロト病院（滋賀県）、神戸白鷺病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043020
