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

JRCT ID: jRCT1042240058

Registered date:23/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Bipolar disorder
• Date of first enrollment: 23/07/2024
• Target sample size: 60
• Study type: Observational

Outcome(s)

• Primary Outcome: SUVR values of [11C]UCB-J and [18F]BCPP-EF in dorsolateral prefrontal cortex in patients with anorexia nervosa and healthy subjects

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 50age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamasue Hidenori
• Secondary Sponsor: Yokokura Masamichi