NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1042240058

Registered date:23/07/2024

In vivo PET Study of Synaptic Density and Mitochondrial Function in Bipolar Disorder

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedBipolar disorder
Date of first enrollment23/07/2024
Target sample size60
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeSUVR values of [11C]UCB-J and [18F]BCPP-EF in dorsolateral prefrontal cortex in patients with anorexia nervosa and healthy subjects
Secondary Outcome1) 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.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 50age old
GenderBoth
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Masamichi Yokokura
Address 1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2295
E-mail ykkr@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine
Scientific contact
Name Hidenori Yamasue
Address 1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2295
E-mail yamasue@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine