Neural responses following rTMS in MDD

JRCT ID: jRCTs052180035

Registered date:29/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients (Major depressive disorder and bipolar II disorder) and healthy controls
• Date of first enrollment: 26/05/2014
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Navigation-guided high-frequency rTMS
site: left dorsolateral prefrontal cortex
frequency: 10Hz (4sec. train, 26sec. interval)
intensity: 100-120% resting motor threshold (RMT)
number of pulses: 2000-3000 pulses/session
number of sessions: 20-30 sessions

Outcome(s)

• Primary Outcome: evaluate neural responses following rTMS using multi-modality of MRI and psychological tests.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Patients
1. Aged 20-75 years-old, male and female
2. Diagnosis of major depressive disorder or bipolar II disorder
3. Current diagnosis of major depressive episode
4. HAMD_17 >=14 or BDI >=20
5. resistent to medication (including medication intolerance)
6. Capability of informed consent

Healthy controls
1. Aged 20-75 years-old, male and female without psychiatric disorder
2. No family history of major depressive disorder and bipolar disorder in their first relatives
3. Capability of informed consent

Exclude criteria

Patients and healthy controls
1. Implanted cardiac pacemaker
2. Surgical aneurysm clips
3. Neurostimulator
4. Implanted pumps
5. Metal fragments in body
6. Subjects who are contraindicated for the use of MRI [e.g. Tattoos, permanent eyeliner (if ink contains metallic specks)]
7. Diagnosis of neurological disorders (including epilepsy), substance dependence, or current serious medical illness (e.g. severe cardiac disease)
8. History of neurological disorders (including epilepsy), substance dependence, or head injury with loss of consciousness
9. Subjects with pregnancy or during lactation.
10. Subjects who are judged as unsuitable for participation in this study

Related Information

• Primary Sponsor: Murai Toshiya
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology, Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000013493