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

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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 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

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

Value
https://center6.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