Mood Disorder Vascular Depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for this clinical study are 1) an inpatient at Kinkou hospital, Kanagawa Psychiatric Center, 2) psychiatric diagnosis of mood disorder (or vascular depression), and 3) an informed consent obtained from a subject. Targetted clinical conditions are major depressive episodes in monopolar and bipolar disorders and vascular depresion which is characterized by prefrontal hypofunction such as hypobulia.
Exclusion criteria
Exclusion criteria: Exclusion criteria for this clinical study are 1) absolute and relative contraindications of rTMS, and 2) lack of an informed consent. The absolute contraindications of rTMS are any magnetic material in subject's head and implanted medical devices such as cardiac pacemakers. The relative contraindications are medical histories of epilepsy or serious head injury and current status of pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Before the first rTMS session, Hamilton Depression Rating Scale (Ham-D) and Beck Depression Inventory (BDI) are performed as clinical evaluation. Mini Mental State Examination and Wechsler Adult Intelligence Scale 3rd Edition (WAIS-III) are performed as cognitive evaluation, and also executive functions related to prefrontal region, such as Wisconsin Card Sorting Test (WCST), Trail Making Test (TMT), Color Stroop Test (CST), and Iowa Gambling Test (IGT), are evaluated as cognitive outcomes. 2 weeks after the initiation of rTMS sessions, clinical scales (Ham-D and BDI) are weekly evaluated until the end of rTMS sessions. After the final rTMS session, neuropsychological testings related to prefrontal executive functions are reevaulated. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety of rTMS sessions, we check any potential side effects at each rTMS session using side effects questionnaire, which was translated in Japanese from original version of Harvard Medical School (Center for Noninvasive Brain Stimulation). | — |
Countries
Japan
Contacts
Kinkou Hospital, Kanagawa Psychiatric Center Department of Psychiatry