UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041120 |
|---|---|
| Receipt number | 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 13:41:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
eye_ve4n.thatmovie_2@icloud.com
Sponsor or person
Institute
Sanzyukai Medical Corporation
Naomasa Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046914
