UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045565 |
|---|---|
| Receipt number | R000052014 |
| Scientific Title | Survey of factors affecting QOL in patients with tardive dyskinesia |
| Date of disclosure of the study information | 2021/09/27 |
| Last modified on | 2023/03/27 10:55:53 |
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Basic information
Public title
Survey of daily life difficulties in patients with tardive dyskinesia
Acronym
Survey of daily life difficulties in patients with tardive dyskinesia
Scientific Title
Survey of factors affecting QOL in patients with tardive dyskinesia
Scientific Title:Acronym
Survey of factors affecting QOL in patients with tardive dyskinesia
Region
| Japan |
Condition
Condition
Tardive dyskinesia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to deepen the understanding of symptoms of tardive dyskinesia (TD) and clarify the importance or significance of treatment, the study will investigate the associations between symptoms of TD and mental& physical distress, and reveal the epidemiological background of specific defect or annoyances affecting QOL in daily life.
Basic objectives2
Others
Basic objectives -Others
N.A.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-VAS Score
-Annoyances (Activities that make you feel distress)
Key secondary outcomes
-Average score for each question
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
-Patients who provide their informed consent to participate in this study
-Patients who are 20 or older and diagnosed with tardive dyskinesia (DSM-5 code: 333.85) based on DSM-5 criteria
-Patients who have self-awareness of their involuntary movements
Key exclusion criteria
-Patients who are judged inappropriate as the subject by researchers
-Patients who withdraw their consent to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Watanabe |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Medical Intelligence department
Zip code
541-8505
Address
3-2-10, Dosho-machi, Chuo-ku, Osaka 541-8505, Japan
TEL
06-6205-5417
watanabe.yumi@mf.mt-pharma.co.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Watanabe |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Medical Intelligence department
Zip code
541-8505
Address
3-2-10, Dosho-machi, Chuo-ku, Osaka 541-8505, Japan
TEL
06-6205-5417
Homepage URL
watanabe.yumi@mf.mt-pharma.co.jp
Sponsor or person
Institute
Mitsubishi Tanabe Pharm Corporation
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharm Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
5chome20banchi9-401 Mita, Minato-ku, Tokyo-to 108-0073 Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2021 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
114
Results
- The mean VAS score for all subjects (mean (SD)):49.2 (27.8)
- The most frequently reported distress on daily activities due to TD symptoms included embarrassment caused by involuntary movements and difficulties to speak, grab objects, or write/type.
Results date posted
| 2022 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
114 patients with TD
Participant flow
Adverse events
NA
Outcome measures
-VAS Score
-Annoyances (Activities that make you feel distress)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N.A.
Management information
Registered date
| 2021 | Year | 09 | Month | 24 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052014
