A clinical trial to examine the distribution of [11C]K-2 in patients with depression and bipolar disorder.

JRCT ID: jRCTs031190150

Registered date:02/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with depression,bipolar disorder
• Date of first enrollment: 03/02/2020
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Administration unapproved drug

Outcome(s)

• Primary Outcome: Correlation with AMPA receptor density and severity of mood symptoms in depression and bipolar disorder

Secondary Outcome

Diagnosis accuracy when discriminating depression and bipolar disorder based on a program optimized by machine learning using the data obtained in this study
Differences in comparing AMPA receptor density of both diseases for each Voxel
Adverse events from 7 days after [11C] K-2 administration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

We will target someone who meets all the following conditions.
1. Psychiatric Diagnostic Interview Manual (Structured Clinical Interview for DSM-IV, SCID-I / DSM-IV), Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5), and International Disease Classification 10th Edition (International Statistical Classification) of Diseases and Related Health Problems 10th Revison, ICD-10) that meet the criteria for depression or bipolar disorder
2. Men and women between 20 and 60 years old at registration
3. Patients who have given written consent to participate in this study.
4. Cases in which the person's consent judgment ability is judged to be sufficient by the evaluation by the MacArthur Competence Assessment Tool (MacCAT)

Exclude criteria

It will be excluded if any of the following conditions apply.
1 During pregnancy, nursing or wishing to be pregnant(For premenopausal women,blood hCG is measured by blood sampling and confirmed to be less than 6 mIU / ml)
2 Sensitive to alcohol
3 Combination of serious neurologic diseases (neurodegenerative diseases, cases of cerebral hemorrhage and cerebral infarction which are not slight in the image before this study participation)
4 History of epilepsy
5 Take Perranpanel, Topiramate within 4 weeks before registration
6 Substance-related disorders within 6 months (except for nicotine and caffeine)
7 Dependent substances positive by urine screening (except those who are positive for the medicine being taken for treatment)
8 Implantation of metal substances and pacemakers
9 head, neck and body size not suitable for MRI scanner
10 A tattoo larger than one point (including tattoo and art makeup)
11 Advanced claustrophobic
12 A remarkable variant of brain structure (including congenital and traumatic)
13 At the time of registration, any of the following laboratory test value abnormalities
Serum creatinine 1.5 mg / dl or more
AST 150 IU / L or more
ALT 150 IU / L or more
14 Participating in unapproved nuclear medicine clinical trials and clinical trials within 6 months prior to enrollment
15 Participating in other trials or clinical trials within 12 weeks prior to enrollment (limited to those with invasiveness / intervention)
16 Patients judged as inappropriate for study by the research investigator

Related Information

• Primary Sponsor: Miyazaki Tomoyuki
• Secondary Sponsor: Takahashi Takuya
• Source(s) of Monetary Support: Strategic Research Program for Brain Science,Takeda Science Foundation,Support by promoting advanced medical care at Yokohama City University Hospital