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

JRCT ID: jRCT1051180029

Registered date:21/01/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: obsessive-compulsive disorder
• Date of first enrollment: 01/04/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

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

Related Information

• Primary Sponsor: Nakamae takashi
• Secondary ID(s): UMIN000022815