UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022815 |
|---|---|
| Receipt number | R000026294 |
| Scientific Title | A longitudinal study of the fluvoxamine treatment for the structural and functional connectivity between the orbitofrontal cortex and the ventral striatum in obsessive compulsive disorder |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2025/01/04 14:14:24 |
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Basic information
Public title
A longitudinal study of the fluvoxamine treatment for the structural and functional connectivity between the orbitofrontal cortex and the ventral striatum in obsessive compulsive disorder
Acronym
A longitudinal study of the fluvoxamine treatment for the structural and functional connectivity between the orbitofrontal cortex and the ventral striatum in obsessive compulsive disorder
Scientific Title
A longitudinal study of the fluvoxamine treatment for the structural and functional connectivity between the orbitofrontal cortex and the ventral striatum in obsessive compulsive disorder
Scientific Title:Acronym
A longitudinal study of the fluvoxamine treatment for the structural and functional connectivity between the orbitofrontal cortex and the ventral striatum in obsessive compulsive disorder
Region
| Japan |
Condition
Condition
obsessive-compulsive disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the neural basis of the obsessive-compulsive disorder applying neuroimaging studies, psychological tests and blood examinations
Basic objectives2
Others
Basic objectives -Others
In the study using mice, repeated stimulation of the orbitofrontal cortex (OFC)-the ventral striatum (VS) projections using optogenetics was reported to increase the firing of postsynaptic VS cells and the frequency of over grooming behavior, which represents obsessive-compulsive symptoms in mice. We have detected the hyper functional and structural connectivities between OFC and VS through the neuroimaging studies of patients with obsessive-compulsive disorder (OCD). Other group reported that this hyper functional connectivity was repaired with deep brain stimulation, while there are no reports with other treatments Thus, in the present study we reveal how these hyper connectivities change with the fluvoxamine that is generally recommended drug to treat OCD in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The strength of the functional and structural connectivity between the orbitofrontal cortex and the ventral striatum evaluated 12 weeks after starting fluvoxamines
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with obsessive-compulsive disorder treated with fluvoxamine. The initial daily dose is 50 mg and gradually increased up to 300 mg given in 2 divided doses.
Interventions/Control_2
healthy volunteers
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
The inclusion criteria for patients were: (1) patients with obsessive compulsive disorder treated at the Kyoto Prefectural University of Medicine Hospital, Kyoto, Japan; (2) not having current or past diagnosis of psychiatric diseases and significant physical disease except the major depressive disorder; (3) the ability to give written, informed consent after receiving a complete description of the study.
The inclusion criteria for healthy controls were: (1) healthy controls matched for age and sex participated in this study without current or past diagnosis of psychiatric diseases and significant physical disease except the major depressive disorder: (2) the ability to give written, informed consent after receiving a complete description of the study.
Key exclusion criteria
The exclusion criteria for patients and healthy controls were: (1) cardiac pacemakers or other metallic implants or artifacts; (2) other factors.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nakamae |
Organization
Graduate School of Medical Science,
Kyoto Prefectural University of Medicine,
Division name
Department of Psychiatry
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
nakamae@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nakamae |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine,
Division name
Department of Psychiatry
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
Homepage URL
nakamae@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Psychiatry,
Graduate School of Medical Science,
Kyoto Prefectural University of Medicine,
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Medical Committee on Human Studies at the Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
京都府立医科大学附属病院精神科・心療内科
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/re/reports/detail/78861
Publication of results
Unpublished
Result
URL related to results and publications
https://jrct.niph.go.jp/re/reports/detail/78861
Number of participants that the trial has enrolled
4
Results
There have been no incidents that raise questions about the safety and scientific validity of the study. There have been no incidents of illness or other problems with the patients enrolled in the study, and there are no safety issues at this time. We have not seen any papers or reports that would affect the content of the study, or deny the scientiic validity of the study. However, due to lack of research funding, we will proceed with the termination of the study.
Results date posted
| 2025 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Number of planned cases: 15 patients with OCD, 15 healthy controls
Number of registered cases: 4 patients with OCD
1 patient was excluded due to a brain abnormality which has no pathological significance.
Age: 34, 40, 30
Sex (male/female): 2/1
Participant flow
Number of planned cases: 15 patients with OCD, 15 healthy controls
Number of registered cases: 4 patients with OCD
1 patient was excluded due to a brain abnormality which has no pathological significance.
Age: 34, 40, 30
Sex (male/female): 2/1
Adverse events
none
Outcome measures
The strength of functional connectivity from the orbitofrontal cortex to the ventral striatum measured by analyzing the functional brain images (Mean (SD))
Before trial -0.000333 (0.307)
6 weeks after 0.00183 (0.143)
12 weeks after 0.0539 (0.138)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026294
