UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053335 |
|---|---|
| Receipt number | R000060785 |
| Scientific Title | Obsessive-compulsive disorder in primary dystonia |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2024/04/19 15:57:17 |
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Basic information
Public title
Obsessive-compulsive disorder in primary dystonia
Acronym
Obsessive-compulsive disorder in primary dystonia
Scientific Title
Obsessive-compulsive disorder in primary dystonia
Scientific Title:Acronym
Obsessive-compulsive disorder in primary dystonia
Region
| Japan |
Condition
Condition
Primary dystonia
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the frequency of obsessive-compulsive disorder in primary dystonia and changes in symptoms over the course of dystonia treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Yale-Brown Obsessive-Compulsive Scale (YBOCS), Maudsley Obsessional-Compulsive Inventory(MOCI) and Self-rating Depression Scale(SDS) scores 8 weeks after starting treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Blepharospasm patient will be administered the YALE-BROWN Obsessive-Compulsive Behavior Scale, the Moseley Obsessive-Compulsive Questions, and the Self-rating Depression Scale. The above tests will be performed 8 weeks after treatment of motor symptoms to evaluate changes in mental symptoms.
Interventions/Control_2
Cervical dystonia patient will be administered the YALE-BROWN Obsessive-Compulsive Behavior Scale, the Moseley Obsessive-Compulsive Questions, and the Self-rating Depression Scale. The above tests will be performed 8 weeks after treatment of motor symptoms to evaluate changes in mental symptoms.
Interventions/Control_3
Hemifacial spasm patient will be administered the YALE-BROWN Obsessive-Compulsive Behavior Scale, the Moseley Obsessive-Compulsive Questions, and the Self-rating Depression Scale. The above tests will be performed 8 weeks after treatment of motor symptoms to evaluate changes in mental symptoms.
Interventions/Control_4
Upper and lower limb spasticity patient will be administered the YALE-BROWN Obsessive-Compulsive Behavior Scale, the Moseley Obsessive-Compulsive Questions, and the Self-rating Depression Scale. The above tests will be performed 8 weeks after treatment of motor symptoms to evaluate changes in mental symptoms.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | < |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diagnosed as blepharospasm and cervical dystonia according to Fahn's definition.
This study does not include secondary dystonia.
As controls, hemifacial spasm and upper and lower limb spasticity were also investigated.
Key exclusion criteria
Under 15 years old
Other cases considered unsuitable for this study
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Shinnichi |
| Middle name | |
| Last name | Matsumoto |
Organization
Osaka Neurological Institute
Division name
Neurology
Zip code
5610836
Address
2-6-23 Shounai Takaramachi Toyonaka Osaka
TEL
06-6333-0086
dyt1mc@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Matsumoto |
Organization
Osaka Neurological Institute
Division name
Department of Neurology
Zip code
5610836
Address
2-6-23 Shounai Takaramachi Toyonaka Osaka
TEL
06-6333-0086
Homepage URL
dyt1mc@yahoo.co.jp
Sponsor or person
Institute
Osaka Neurological Institute Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Neurological Institute / IRB
Address
2-6-23 Shounai Takaramachi Toyonaka Osaka
Tel
06-6333-0086
dyt99mc@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 12 | 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
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060785
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/07/13 | OCD 研究計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/07/13 | 症例データ 仕様書.xls |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/07/13 | 症例データ .xls |
Single case data URL
Value
https://center6.umin.ac.jp/ice/60785
