UMIN-CTR Clinical Trial

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