The development of new treatment for depression by neurofeedback.

JRCT ID: jRCTs062190030

Registered date:30/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: depression
• Date of first enrollment: 02/04/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): A one-day NFB session takes about 45 minutes. The sessions are conducted 5 times within 2 weeks.

Outcome(s)

Primary Outcome

Hamilton Rating Scale for Depression(HRSD)
Beck Depression Inventory(BDI-II)
The Positive and Negative Affect Schedule(PANAS)

Secondary Outcome

Rumination Reflection Questionnaire(RRQ)
Ruminative Response Scale(RRS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

(1)Patients aged 20 years and over,under 80 years (outpatient or hospitalized patient).
(2)Subjects are diagnosed with major depressive disorder according to DSM-TR or DSM-5.
(3)Currently subjects meet diagnostic criteria for major depressive episodes (according to M.I.N.I.).
(4)In the latest major depressive episodes,with treatment-resistant(HRSD score is 14 points or more with sufficient doses of antidepressants for 4 weeks or more) or with treatment low tolerance(impossible to take in adequate amount antidepressants by serious side effects).
(5)Signed informed consent by oneself.

Exclude criteria

(1)Incapability to understand the purpose of the study.
(2)Impossible to examine on the ground of serious illness.
(3)It`s difficult for subjects below to get an MRI.
- With an implanted cardiac pacemaker.
- With a brain vascular clip.
- Users of a nerve electrical stimulator.
- With an implanted pump in one's body.
- With a piece of metal in one's body.
- With tattoos (including permanent makeup etc).
- Pregnancy or possibly pregnant.
- MRI claustrophobia.
(4)Those participating in other intervention studies.

Related Information

• Primary Sponsor: Okamoto Yasumasa