UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034779 |
|---|---|
| Receipt number | R000039606 |
| Scientific Title | Adherence to Antipsychotics in Treatment-Resistant Schizophrenia: A Prospective Observational Study |
| Date of disclosure of the study information | 2018/11/06 |
| Last modified on | 2021/08/03 11:25:36 |
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Basic information
Public title
Adherence to Antipsychotics in Treatment-Resistant Schizophrenia: A Prospective Observational Study
Acronym
Adherence to Antipsychotics in Treatment-Resistant Schizophrenia: A Prospective Observational Study
Scientific Title
Adherence to Antipsychotics in Treatment-Resistant Schizophrenia: A Prospective Observational Study
Scientific Title:Acronym
Adherence to Antipsychotics in Treatment-Resistant Schizophrenia: A Prospective Observational Study
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify apparent treatment-resistant schizophrenia (TRS) by measuring medication adherence with Medication Event Monitoring System (MEMS)
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between medication adherence and symptom severity in TRS
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Medication adherence measured by MEMS (at 12 weeks)
Key secondary outcomes
(1) Medication adherence measured by pill counts or Brief Adherence Rating Scale (BARS)
(2) Psychopathology measured by rating scales
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with treatment-resistant schizophrenia receiving only oral antipsychotics
Key exclusion criteria
None
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Takeuchi |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, JAPAN
TEL
03-3353-1211
hirotak@dk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Takeuchi |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, JAPAN
TEL
03-3353-1211
Homepage URL
hirotak@dk9.so-net.ne.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
SENSHIN Medical Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
山梨県立北病院（山梨県）、大泉病院（東京都）、木野崎病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study.
Management information
Registered date
| 2018 | Year | 11 | Month | 05 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039606
