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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022815
Receipt No. 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 2021/06/24

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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
Email 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
Email nakamae@koto.kpu-m.ac.jp

Sponsor
Institute Department of Psychiatry,
Graduate School of Medical Science,
Kyoto Prefectural University of Medicine,
Institute
Department

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
Email 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
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 Open public recruiting
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
2021 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026294

Research Plan
Registered date File name
2018/12/26 研究計画書_フルボキサミン縦断研究20181126.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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