Last updated: January 22, 2023
Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Depression
Depression (Major/severe)
Affective Disorders
Treatment
N/AClinical Study ID
NCT05707299
2022ZX010-fNIRS
Ages 15-22 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Inclusion criteria for control group:
- Healthy control participants who could provide a recent depression screening report,and confirm they have not any cardiovascular, respiratory, digestive, urinary,hematological, endocrine, or neurological disease;
- 15 ≤ age ≤22 years, male or female;
- Participants have clear consciousness and could communicate with others normally;
- Participants could understand the full study protocol and have high adherence. Writteninformed consent is signed by adult participants themselves,and the minor participantsis signed by a guardian;
- Participants should be right-handed; Inclusion criteria for observation group:
- MDD patients should meet the diagnostic criteria of the International Classificationof Diseases 11th Edition (ICD-11) diagnostic criteria for MDD;
- 15≤ age ≤22, male or female;
- Participants have clear consciousness and could communicate with others normally;
- Participants could understand the full study protocol and have high adherence. Writteninformed consent is signed by adult participants themselves,and the minor participantsis signed by a guardian;
- Not taking antidepressants or antipsychotic drugs for at least 4 weeks beforeenrollment;
- Participants should be right-handed;
Exclusion
Exclusion Criteria: Exclusion criteria for control group:
- Participants with serious primary diseases of cardiovascular diseases, liver diseases,kidney diseases, urinary diseases, and hematological diseases;
- Participants have an illness, alcohol dependence, or a history of drug abuse;
- Pregnant or lactating participants;
- Participants with intellectual disabilities who can't cooperate with the questionnairesurvey;
- Participants with bleeding tendency, skin disease, allergic constitution, and allergicto adhesive tape;
- The test site of participants has scars, hyperpigmentation, red and swollen;
- Participants are participating in other trials; Exclusion criteria for observation group:
- Participants with serious primary diseases of cardiovascular, respiratory, digestive,urinary, hematological, endocrine, neurological disease, and other serious primarydiseases, and the disease cannot be effectively controlled clinically;
- MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactivesubstances, and non-addictive substances;
- Participants with suicidal tendencies;
- Pregnant or lactating participants;
- Participants with intellectual disabilities who cannot cooperate with thequestionnaire survey;
- Participants with bleeding tendency, skin disease, allergic constitution, and allergicto adhesive tape;
- The skin at the test site of participants has scars, hyperpigmentation, red andswollen;
- Participants are participating in other trials;
Study Design
Total Participants: 40
Study Start date:
February 01, 2023
Estimated Completion Date:
May 31, 2024
Study Description
Connect with a study center
the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting]
Hangzhou, Zhejiang
ChinaSite Not Available

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