- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03595020
Probing Prefrontal Cortex Hemodynamic Alterations for Major Depression Disorder (MDD)
Probing Prefrontal Cortex Hemodynamic Alterations During Facial Emotion Recognition for Major Depression Disorder Through Functional Near-infrared Spectroscopy
연구 개요
상태
정황
상세 설명
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Shaanxi
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Xi'an, Shaanxi, 중국, 710032
- Department of psychiatry, Xijing Hospital; Research Institute of Biomedical Engineering, Xi'an Jiaotong University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- MDD group:
All subjects were free of psychotropic medication for a minimum of 4 weeks; Psychiatric diagnosis was determined by DSM-IV criteria; Depressed subjects were included with 17-item Hamilton Rating Scale for Depression (HRSD) scores ≥ 18; Mini-mental State Examination(MMSE) ≥ 24; All subjects had normal or corrected-to-normal vision.
- HC group:
All subjects were free of psychotropic medication for a minimum of 4 weeks; All subjects did not have any mental, neurological or physical diseases;HRSD scores ≤ 7; MMSE ≥ 28; All subjects had normal or corrected-to-normal vision.
Exclusion Criteria:
- Exclusion criteria were any history of neurologic trauma resulting in loss of consciousness, any current neurologic disorder, any lifetime psychiatric disorder other than major depression in the MDD subjects, or any lifetime psychiatric disorder in control subjects. Careful attention was paid to excluding substance abuse disorders.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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MDD group
The major depression group (MDD group) received antidepressant treatment but did not interfere with drug selection.
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HC group
The healthy control group (HC group) don't accept intervention and treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Hamilton Depression Scale-17(HAMD-17) score alterations
기간: Change from baseline HAMD-17 scores at 6 months
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The HAMD-17 scores are to evaluate the severity degree of depression, and the HAMD-17 scores reduction rate is used to evaluate the clinical treatment effect.
If the reduction rate exceeds 50%, it indicates that the clinical treatment is effective.
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Change from baseline HAMD-17 scores at 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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facial emotion recognition
기간: Difference at facial emotion recognition between day 1 and month 6.
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The ability to correctly recognize emotional states from faces is instrumental for interpersonal engagement and social functioning.
Impairments processing of facial emotional expressions and biased facial emotion detection are frequently found in the MDD patients.
Functional near-infrared spectroscopy (fNIRS) has not been applied for the facial emotion recognition for the depression patients up to now.
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Difference at facial emotion recognition between day 1 and month 6.
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Pittsburgh Sleep Quality Index(PSQI)
기간: Difference at PSQI between day 1, month 3 and month 6.
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PSQI was used to assess the quality of sleep for subjects in the recent month.
The total score ranges from 0 to 21 points.
The higher the score, the worse the sleep quality.
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Difference at PSQI between day 1, month 3 and month 6.
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Huaning Wang, doctorate, Department of Psychiatry, Xijing Hospital
간행물 및 유용한 링크
일반 간행물
- Zwick JC, Wolkenstein L. Facial emotion recognition, theory of mind and the role of facial mimicry in depression. J Affect Disord. 2017 Mar 1;210:90-99. doi: 10.1016/j.jad.2016.12.022. Epub 2016 Dec 19.
- Tsuchida A, Fellows LK. Are you upset? Distinct roles for orbitofrontal and lateral prefrontal cortex in detecting and distinguishing facial expressions of emotion. Cereb Cortex. 2012 Dec;22(12):2904-12. doi: 10.1093/cercor/bhr370. Epub 2012 Jan 5.
- Takizawa R, Fukuda M, Kawasaki S, Kasai K, Mimura M, Pu S, Noda T, Niwa S, Okazaki Y; Joint Project for Psychiatric Application of Near-Infrared Spectroscopy (JPSY-NIRS) Group. Neuroimaging-aided differential diagnosis of the depressive state. Neuroimage. 2014 Jan 15;85 Pt 1:498-507. doi: 10.1016/j.neuroimage.2013.05.126. Epub 2013 Jun 10. Erratum In: Neuroimage. 2015 Apr 1;109:530.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .