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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041120
Receipt No. R000046914
Scientific Title Improvement of psychiatric symptoms and social function of aripiprazole long acting injection for outpatient schizophrenia
Date of disclosure of the study information 2020/07/16
Last modified on 2020/08/23

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Basic information
Public title Improvement of psychiatric symptoms and social
function of aripiprazole long acting injection
for outpatient schizophrenia
Acronym Improvement of psychiatric symptoms and social
function of aripiprazole long acting injection
for outpatient schizophrenia
Scientific Title Improvement of psychiatric symptoms and social
function of aripiprazole long acting injection
for outpatient schizophrenia
Scientific Title:Acronym Improvement of psychiatric symptoms and social
function of aripiprazole long acting injection
for outpatient schizophrenia
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In Japan, it is said as follows. Long-acting injection (LAI) has not
become popular compared to other countries, and schizophrenia
patients are not benefiting from it. We believe that understanding the clinical utility of atypical antipsychotic LAI, that is, the actual
condition of changes in social function as well as psychotic
symptoms, will motivate doctors who have never used LAI to start
using it. Therefore, we would like to conduct a retrospective study
with the aim of clarifying the clinical characteristics of aripiprazole
LAI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes For patients who have been treated with aripiprazole LAI
for more than 1 year from May 2015 to July 2020, the social
function before and after switching from the previous drug will be
evaluated by SOFAS according to the patient background.
Key secondary outcomes The improvement of psychotic symptoms is also evaluated by CGI-I. Treatment continuation rate. Timing of improvement depending on
the number of doses

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A patient with schizophrenia who has been treated with aripiprazole LAI for more than 1 year between May 2015 and April 2020
at Naomasa Clinic.
Key exclusion criteria Patients who do not meet the above selection criteria.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Tetsushi
Middle name
Last name Naomasa
Organization Sanzyukai Medical Corporation
Division name Naomasa Clinic
Zip code 904-0031
Address 2chome 12ban 18gou Uechi Okinawa City
TEL 098-989-9229
Email eye_ve4n.thatmovie_2@icloud.com

Public contact
Name of contact person
1st name Tetsushi
Middle name
Last name Naomasa
Organization Sanzyukai Medical Corporation
Division name Naomasa Clinic
Zip code 904-0031
Address 2chome 12ban 18gou Uechi Okinawa City
TEL 098-989-9229
Homepage URL
Email eye_ve4n.thatmovie_2@icloud.com

Sponsor
Institute Sanzyukai Medical Corporation
Naomasa Clinic
Institute
Department

Funding Source
Organization Sanzyukai Medical Corporation
Naomasa Clinic
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 Ichigaya Himorogi Clinic Ethics Committee
Address Ichigaya ASUKARU Building Tamachi Ichigaya Shinjuku Ward Tokyo Prefecture
Tel 03-5946-8584
Email hiruma.mayumi@himorogi.org

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

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 16 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
2020 Year 06 Month 17 Day
Anticipated trial start date
2020 Year 08 Month 25 Day
Last follow-up date
2020 Year 08 Month 31 Day
Date of closure to data entry
2020 Year 09 Month 05 Day
Date trial data considered complete
2020 Year 09 Month 10 Day
Date analysis concluded
2020 Year 09 Month 15 Day

Other
Other related information To conduct a retrospective cohort observational study of patients
who have been treated with aripiprazole LAI for more than 1 year
from May 2015 to July 2020. The social function before and after
switching from the previous drug is evaluated by SOFAS according to the patient background.

Management information
Registered date
2020 Year 07 Month 15 Day
Last modified on
2020 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046914

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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