臨床研究等提出・公開システム

Date of registration	July. 23, 2024
Last modified on	July. 23, 2024
Trial ID	jRCT1042240058

Scientific Title	Comparative Study of Synaptic Density and Mitochondrial Function in Bipolar disorder and Healthy Individuals Using Positron Emission Tomography
Public Title	In vivo PET Study of Synaptic Density and Mitochondrial Function in Bipolar Disorder

Contact for Scientific Queries	Name	Yamasue Hidenori
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
	Telephone	+81-53-435-2295
	E-mail	yamasue@hama-med.ac.jp
Contact for Public Queries	Name	Yokokura Masamichi
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
	Telephone	+81-53-435-2295
	E-mail	ykkr@hama-med.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		July. 23, 2024
Target sample size		60
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	1) Individuals aged between 18 and 50 years at the time of consent 2) Individuals who have provided consent through signing the informed consent form 3) (Applicable only to patients with bipolar disorder) Individuals diagnosed with bipolar disorder according to the DSM-5, the international diagnostic criteria
	Exclusion Criteria	1) Individuals with a current or past history of organic brain diseases 2) Individuals with mitochondrial diseases 3) Individuals with coexisting substance-related disorders 4) For women, individuals who are pregnant or may be pregnant 5) Individuals unable to undergo PET due to claustrophobia or similar reasons 6) Individuals unable to undergo MRI due to the presence of metallic implants (such as brain clips or pacemakers) or tattoos 7) (Applicable only to healthy individuals) Individuals with a current or past history of mental disorders
	Age Minimum	18age old over
	Age Maximum	50age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Bipolar disorder
Health Condition(s) Keyword		Bipolar disorder
Health Condition(s) Code		D001714
Primary Outcome(s)		SUVR values of [11C]UCB-J and [18F]BCPP-EF in dorsolateral prefrontal cortex in patients with anorexia nervosa and healthy subjects
Secondary Outcome(s)		1) SUVR values of [11C]UCB-J and [18F]BCPP-EF in brai n regions other than the dorsolateral prefrontal cortex in patients with bipolar disorder and healthy subjects. 2) Psychological and clinical assessments: Evaluation of g eneral mental disorders (SCID), depression assessment (BDI-2), manic aseessment (YMRS), intellectual ability assessment (JART), stress and anxiety assessment (STAI), social and economic status assessment (SES), handed ness assessment (Edinburgh Handedness Inventory). 3) MRI: MRS imaging to measure metabolite concentration s such as GABA and glutamate, resting-state functional M RI to measure functional connectivity, DTI imaging to meas ure neural fiber tracts.

Name of Certified Review Board	Ethics Committee of Hamamatsu University School of Med icine
Address	1-20-1, Handayama, Chuo-ku, Hamamatsu, Shizuoka, Shi zuoka, Shizuoka
Telephone	+81-53-435-2680
E-Mail	rinri@hama-med.ac.jp
Approval Status	Approval
Date of approval	April. 04, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none