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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032210317

Registered date:16/09/2021

QPS study for treatment-resistant depression

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMajor Depressive Disorder
Date of first enrollment16/09/2021
Target sample size56
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)MRI neuro-navigation system is used to identify the optimal stimulation site in the prefrontal cortex for each subject, and quadripulse transcranial magnetic stimulation (QPS) protocol is performed once a day for a total of 10 times over about 2 weeks. The intervention is randomly assigned to the real stimulation group and the placebo stimulation group based on age, sex, and severity of depression.

Outcome(s)

Primary OutcomeTotal score changes in the Montgomery Asberg Depression Rating Scale (MADRS) from the baseline.
Secondary Outcome<Clinical evaluations> - 21-item Hamilton Rating Scale for Depression (HRSD-21) - 16-item Quick Inventory of Depressive Symptoms-Japanese version (QIDS16-J) - Brief Symptom Inventory-anxiety subscale (BSI-anxiety) - Beck Suicide Scale for Suicide Ideation (BSS) - Pittsburgh Sleep Quality Index (PSQI) - Quality of Life Enjoyment and Satisfaction Scale (QLESQ) <Cognitive evaluations> - Montreal Cognitive Assessment (MoCA) - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Letter Number Sequencing Test (LNST) - Stroop Neuropsychological Screening Test (SNST) - Trail Making Test (TMT) - The Executive Interview (EXIT25) <Biological evaluations> - Resting-state EEG - Multimodal MRI (T1, resting-state functional MRI (rs-fMRI), diffusion tensor imaging (DTI), magnetic resonance spectroscopy (MRS)) -Auditory Steady-State Response (ASSR) - Polysomnography (PSG) - TMS-EEG neurophysiology - Holter ECG - AMPA-PET

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 65age old
GenderBoth
Include criteriaPatients with treatment-resistant depression that meet the following conditions: - Person who is between 20 and 65 years old at the time of obtaining informed consent. - Those who meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). - Persons who have a severity of 18 or more on the score of MADRS. - Person who is able to obtain written consent.
Exclude criteria- Patients who have cerebral organic diseases (intracranial organic lesions of moderate or higher grade, neurodegenerative diseases, etc.). - Patients with a history of seizures or epilepsy, serious or unstable physical illness. - Metal implants, pacemakers, people with contraindications for TMS or MRI such as claustrophobia.

Related Information

Contact

Public contact
Name Yoshihiro Noda
Address 35 Shinanomachi, Shinjuku-ku, Tokyo Tokyo Japan 160-8582
Telephone +81-3-3353-1211
E-mail yoshi-tms@keio.jp
Affiliation Keio University Hospital
Scientific contact
Name Masaru Mimura
Address 35 Shinanomachi, Shinjuku-ku, Tokyo Tokyo Japan 160-8582
Telephone +81-3-3353-1211
E-mail mimura@a7.keio.jp
Affiliation Keio University Hospital