JPRN-jRCTs062180027
Recruiting
Phase 1
The development of treatment using neurofeedback for patients with mood disorder: an exploratory study through neuroimaging approaches - The development of treatment for mood disorder by NFB
Okada Go0 sites130 target enrollmentFebruary 26, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Mood disorders (major depressive disorder and bipolar disorder) and healthy volunteers
- Sponsor
- Okada Go
- Enrollment
- 130
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\[For patients/clients ]
- •1\) Aged 20\-80 years old
- •2\) Being diagnosed as major depressive disorder or bipolar disorder (Type I, Type II) according to DSM\-IV\-TR or DSM\-V criteria
- •3\) Present ongoing episode of major depressive symptoms
- •4\) Present treatment\-resistance (scores 14 points or above out of 17 items on the Hamilton Rating Scale for Depression even after \>\=4 weeks of treatment with sufficient amount of more than 1 kinds of anti\-depressants) or low treatment\-tolerance (insufficient administration due to side\-effects while taking more than 1 kinds of anti\-depressants)
- •5\) Satisfactory informed consent obtained from the participant him/herself
- •\[For healthy control]
- •1\) Aged 20\-80 years old
- •2\) Not history of psychiatric disorders
- •3\) Not having current serious medical illness
Exclusion Criteria
- •1\) Decisionally impaired individuals who has diminished capacity to understand the aim of the research
- •2\) Physically impaired individuals who are not able to complete the experiment
- •3\) Subjects who are contraindicated for the use of MRI
- •Having an implanted heart pace\-maker
- •Having implanted cerebral (arteries) clips
- •Having implanted neural/nerve stimulators
- •Having implanted pumps
- •Having work experience in a metal industry or possibility of metal residues remaining in the body
- •Having metal\-tattoos (including tattooed eye\-lining)
- •Being pregnant, or having possibility of being pregnant
Outcomes
Primary Outcomes
Not specified
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