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Efficacy of Spectrally Optimized Light on Cognitive Impairment in Major Depressive Disorder and Its Neuroimaging Mechanisms

NCT07508215 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-02

No results posted yet for this study

Summary

This study aims to validate the therapeutic efficacy and safety of spectrally optimized light (SOL) in ameliorating cognitive impairment (CI) in major depressive disorder (MDD), characterize the functional and structural features of the hippocampus （HPC）-dorsolateral prefrontal cortex （dlPFC） neural circuitry in MDD patients with cognitive impairment and examine the mediating effect of the HPC-dlPFC neural circuit on the cognitive improvements induced by SOL treatment in MDD-CI patients. Patients with MDD-CI are required to only receive selective serotonin reuptake inhibitors (SSRIs) as primary medication for at least one week or not do anything treatment before. SOL is a kind of Bright Light Therapy(BLT). Qualified participants will be randomly assigned to the experimental group and the control group. The experimental group will receive the intervention of BLT, and the control group will receive the intervention of dim red light (placebo). The intervention will last for four weeks. The participants will be followed once in a week during intervention and in 4th week after intervention. Demographic information will be collected at baseline, cognitive function will be evaluated at baseline, 2nd, ,4th and 8th weekends after intervention beginning. and other symptoms such as depression, anxiety and sleep were assessed at baseline, 1st, 2nd, 3rd ,4th and 8th weekends after intervention beginning.Moreover, structural and functional MRI scans will be made at baseline and after four weeks intervention. During intervention, patients with MDD-CI will keep a record of daily light exposure duration, complete the daily sleep diary as well.

Conditions

Interventions

DEVICE

bright light

Using a hybrid white light box with independent intellectual property rights, with an intensity of 10000lux and a main wavelength of 476.4nm

DEVICE

dim red light(placebo)

Using a dim red light box as the placebo, with an intensity of \<200lux and a main wavelength of 690.4nm

Sponsors & Collaborators

  • Peking University Sixth Hospital

    lead OTHER

Principal Investigators

  • Xiaozhen Lv, Ph.D · Peking University Sixth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07508215 on ClinicalTrials.gov