NIPH Clinical Trials Search

JRCT ID: jRCTs031190150

Registered date:02/12/2019

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPatients with depression,bipolar disorder
Date of first enrollment03/02/2020
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)Administration unapproved drug


Primary OutcomeCorrelation with AMPA receptor density and severity of mood symptoms in depression and bipolar disorder
Secondary OutcomeDiagnosis 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
Include criteriaWe 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 criteriaIt 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


Public contact
Name Tsuyoshi Eiro
Address 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan Kanagawa Japan 236-0004
Telephone +81-45-787-2579
Affiliation Yokohama City University, School of Medicine
Scientific contact
Name Tomoyuki Miyazaki
Address 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan Kanagawa Japan 236-0004
Telephone +81-45-787-2579
Affiliation Yokohama City University Hospital