UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017407 |
|---|---|
| Receipt number | R000020193 |
| Scientific Title | The effectiveness study of psychotropic-induced side effect monitoring by community pharmacists |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2017/02/10 02:22:06 |
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Basic information
Public title
The effectiveness study of psychotropic-induced side effect monitoring by community pharmacists
Acronym
The effectiveness study of psychotropic-induced side effect monitoring by community pharmacists
Scientific Title
The effectiveness study of psychotropic-induced side effect monitoring by community pharmacists
Scientific Title:Acronym
The effectiveness study of psychotropic-induced side effect monitoring by community pharmacists
Region
| Japan |
Condition
Condition
Mental illness
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness of psychotropic-induced side effect monitoring conducted by community pharmacists
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Number of times of prescription change and/or dose adjustment
2) Change of psychotropic dosage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Monitoring of psychotropic-induced side effects conducted by community pharmacists
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with mental illness received prescriptions in study community pharmacies
Key exclusion criteria
none
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ataru Inagaki |
Organization
Aoyama Gakuin University
Division name
Health Administration Center
Zip code
Address
4-4-25 Shibuya, Shibuya, Tokyo, Japan 150-836
TEL
03-3409-7896
ina-chun@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ataru Inagaki |
Organization
Aoyama Gakuin University
Division name
Health Administration Center
Zip code
Address
4-4-25 Shibuya, Shibuya, Tokyo, Japan 150-836
TEL
03-3409-7896
Homepage URL
ina-chun@hotmail.co.jp
Sponsor or person
Institute
Aoyama Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Toho University Faculty of Pharmaceutical Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
ひもろぎ心のクリニック（東京都），茜薬局（東京都），萩原薬局（東京都），公益財団法人住吉偕成会住吉病院（山梨県），池川薬局（山梨県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://mhlw-grants.niph.go.jp/niph/search/NIDD02.do?resrchNum=201523012A
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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 03 | Day |
Last modified on
| 2017 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020193
