Development of a new form of rTMS treatment for TRD

JRCT ID: jRCTs032180188

Registered date:06/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Treatment Resistance Depression
• Date of first enrollment: 06/03/2019
• Target sample size: 180
• Study type: Interventional

Intervention(s)

(1)Conventional sequential bilateral rTMS treatment
(2)Novel sequential bilateral theta-burst stimulation rTMS treatment

Outcome(s)

Primary Outcome

Acute phase: Difference between Montgomery Asberg Depression Rating Scale(MADRS) from baseline to endpoint
Maintenance phase: Difference between Montgomery Asberg Depression Rating Scale(MADRS) from baseline to endpoint

Secondary Outcome

Acute phase: <Clinical evaluation> Difference of following scale from baseline to endpoint: 17 Item Hamilton Rating Scale for Depression(HRSD-17), Brief Symptom Inventory-anxiety subscale (BSI-anxiety), 16-item Quick Inventory of Depressive Symptoms-Japanese version (QIDS16-J), Beck Suicide Scale for Suicide Ideation (BSS), Pittsburgh Sleep Quality Index (PSQI)
<Cognitive function evaluation> Difference of following scale from baseline to endpoint: Montreal Cognitive Assessment (MoCA), Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Letter Number Sequencingtest (LNS), Stroop Neuropsychological Screening Test (SNST), Trail Making Test (TMT), The Executive Interview (EXIT25)

Maintenance phase: <Clinical evaluation> Difference of following scale from baseline to endpoint: 17 Item Hamilton Rating Scale for Depression(HRSD-17), Brief Symptom Inventory-anxiety subscale (BSI-anxiety), 16-item Quick Inventory of Depressive Symptoms-Japanese version (QIDS16-J), Beck Suicide Scale for Suicide Ideation (BSS), Pittsburgh Sleep Quality Index (PSQI)
<Cognitive function evaluation> Difference of following scale from baseline to endpoint: Montreal Cognitive Assessment (MoCA), Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Letter Number Sequencingtest (LNS), Stroop Neuropsychological Screening Test (SNST), Trail Making Test (TMT), The Executive Interview (EXIT25)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

(1) Outpatients or inpatients of Neuropsychiatry, Keio University Hospital
(2) 18 years old or over when obtaining consent
(3) Patient who is able to give a written consent according to an attending physician
(4) Meeting the diagnostic criteria of Major Depressive disorder based on DSM-5
(5) The current episode is scored 3 or greater in ATHF, or nonresponsive to two different kind of antidepressants in the past
(6) The score 18 or greater MADRS
(7) Mental condition is stable enough for the examination

Exclude criteria

(1)Patients with organic brain disorder (Moderate or severe intracranial organic lesions or neurodegenerative disease)
(2) History of seizures and/or epilepsy
(3) Diagnosis of substance related disorders in the last 6 months
(4) Serious or unstable physical condition
(5) Received rTMS or ECT treatment in the last 6 months
(6) Having contraindications of TMS or MRI, such as metal-containing objects or a heart pacemaker implanted in the body or claustrophobic
(7) The size of the head, neck, or body not suitable for MRI devices
(8) Other cases considered unsuitable for the study by the investigator or collaborating physicians

Related Information

• Primary Sponsor: Noda Yoshihiro
• Secondary Sponsor: Nakajima Shinichiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,TEIJIN PHARMA LIMITED.