NCT07508215

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Peking University Sixth Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study was designed as a randomized controlled study. It focuses on patients with MDD-CI, with an experimental group and a control group established. The experimental group was treated with one of six SSRIs, including Fluoxetine, Paroxetine, Sertraline, Citalopram, Fluvoxamine, and Escitalopram. The medication maintained unchanged throughout the entire intervention. The experimental group received the intervention of BLT, and the control group additionally received the intervention of dim red light (placebo). The intervention lasts for four weeks (six days per week, 45 min per day between 7am and 10 am). Follow-up will be conducted once at the 4th weekends after intervention. Cognitive appraisal will be conducted using the Chinese version of Measurement Consensus Cognitive Battery (MCCB),The Chinese Biref Cognitive Test(C-BCT),and Perceived Deficits Questionnaire(PDQ)at baseline, 2nd, 4th and 8th weekend after intervention beginning. Other clinical symptoms will be assessed by The 17-item Hamilton Depression Rating Scale (HAMD-17),Hamilton Anxiety Rating Scale (HAMA), Clinical Global Impression (CGI), Young Mania Rating Scale, (YMRS), Quick Self Rating Depression Symptoms Scale (QIDS), 7-item Generalized Anxiety Disorder Scale (GAD-7) ,Pittsburgh sleep quality index (PSQI),Chinese version of the Short Form of Quality of Life Enjoyment and Satisfaction Questionnaire(Q-LES-Q-SF) and Sheehan Disability Scale(SDS) at baseline, 1st, 2nd, 3rd, 4th and 8th weekends after intervention beginning. At the same time, the Safety and Applicability of the intervention during the treatment process were investigated using the Side Effects Rating Scale for Serotonin Specific Reuptake Inhibitors (SERS-SSRIs) and the Treatment Compliance Record Form.

Conditions

• Major Depressive Disorder (MDD)
• Neuroimaging
• Bright Light Treatment
• Cognitive Impairment

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

2 sites across 1 country: China