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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

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

4

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

Due to lack of research funding, there is no prospect of registring a fifth and subsequent cases. Therefore, we will proceed with the termination of the study.

To date, 4 patients with obsessive-compulsive disorder have been registered in this study, and 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.

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)

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.

Mar. 31, 2024

No

Not available

https://jrct.mhlw.go.jp/latest-detail/jRCT1051180029

Nakamae takashi

University hospital Kyoto prefectural university of medicine

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan

nakamae@koto.kpu-m.ac.jp

Abe Yoshinari

University hospital Kyoto prefectural university of medicine

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan

+81-75-251-5612

abeyoshi@koto.kpu-m.ac.jp

Complete

April. 01, 2019

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

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.

The exclusion criteria for patients and healthy controls were: (1) cardiac pacemakers or other metallic implants or artifacts; (2) other factors.

Both

obsessive-compulsive disorder

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.

The strength of functional and structural connectivity from the orbitofrontal cortex to the ventral striatum measured by analyzing the functional brain images and the diffusion tensor images.

The severity of obsessive-compulsive symptoms (measured by Y-BOCS), the serum concentrations of 5-HT, dopamine, glutamate and their precursors, metabolites.

+81-75-251-5337

Dec. 04, 2018

none