A Multicentre Clinical Study

NCT07062666 | Not Yet Recruiting FDA Drug FDA Device

• 1 other identifier: MR-32-25-015243
• Study Type: observational
• Target: 2,250
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study intends to conduct a multi-center, large-sample clinical trial, aiming at using multi-channel near-infrared spectroscopy to detect the characteristics of brain Oxy-Hb changes over time during cognitive activation in patients with depression before treatment and in the gender - and age-matched control group, and using eye tracking technology to detect the eye movement characteristics of patients with depression before treatment and in the gender - and age-matched control group. The sensitivity and specificity of fNIRS spectrum and eye movement index in objective diagnosis of patients with depressive disorder were calculated, and according to the HAMD reduction rate, depression patients after 2 weeks of treatment were divided into remission group and non-remission group. fNIRS imaging and eye movement indexes in depression group and normal control group were compared, fNIRS imaging and eye movement indexes in depression remission group before and after treatment, fNIRS imaging and eye movement indexes in depression remission group and non-remission group were compared at baseline to verify the biomarkers of fNIRS spectrum and eye movement indexes in predicting antidepressant efficacy. Finally, it provides reliable scientific evidence for the important role of fNIRS imaging and eye tracking technology in the diagnosis and treatment of depression.

Conditions

the Objective Diagnosis of Depression

Outcome Measures

Primary Outcomes (1)

• fNIRS

  Sensitivity and specificity

  2024～2025

Study Arms (2)

depressive patients

Drug: SSRIs; Device: fNIRS

controls

Device: fNIRS

Interventions

SSRIs DRUG

take SSRIs for 2 weeks

depressive patients

fNIRS DEVICE

All subjects receive fNIRS examination.

controls; depressive patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

depressive patients

You may qualify if:

• Aged 18-60 years old; ② Right-handed; ③ Meet the DSM-5 diagnostic criteria for depression; ④ The current course of disease (last onset) is at least 2 weeks; ⑤HAMD-17 score ≥17 points; ⑥ No electroconvulsive therapy was received in the first six months.

You may not qualify if:

• A combination of another mental illness; A history of alcohol/drug dependence or smoking \> 10 cigarettes/day; ③ Serious physical diseases of the heart, liver, kidney, brain and hematopoietic system, central nervous system infection, head injury, epilepsy, multiple sclerosis, toxic metabolic diseases, Parkinson's disease or intracranial tumors; ④ Family history of hereditary diseases; ⑤Endocrine system diseases such as diabetes, hyperthyroidism or hypothyroidism; ⑥ Pregnant, lactating women or photosensitivities.

Sponsors & Collaborators

• Zhongda Hospital: lead

MeSH Terms

Interventions

Selective Serotonin Reuptake Inhibitors

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Scientific Committee

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: July 30, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07