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

NCT07508215 | Not Yet Recruiting

• 1 other identifier: 7262156
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

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

Keywords

Major Depressive Disorder; Neuroimaging; Magnetic Response Imaging; Bright Light Therapy; Cognitive Impairment; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

• Stroop Color-Word Test

  The Stroop Color Word Test (SCWT) was developed by Professor Stroop in 1935 to evaluate subjects' executive functions. The test is a measure of selective attention and the degree of inhibition of irrelevant information in executive functioning. It consists of three main parts: reading words (Stroop-w), color naming (Stroop-c), and color-word interference (Stroop-cw), which require subjects to accurately and quickly read the words or the colors, respectively, as required.

  baseline,the 2nd and 4th weekends after the start of the 4-week intervention,and the 4th weekend after the 4-week intervention.

• Hopkins Verbal Learning Test-Revised

  Hopkins Verbal Learning Test-Revised (HVLT-R) is a widely used neuropsychological assessment tool designed to evaluate verbal memory and cognitive function. Developed by J. Brandt and Benedict in 2001, the HVLT-R consists of a list of 12 nouns divided into three semantic categories (e.g., dwelling places, four-legged animals, and precious stones), with four words per category. The assessment involves three learning trials, where participants are presented with the list of words and are asked to recall as many words as possible immediately after each presentation. Additionally, there is a delayed recall trial, where participants are asked to recall the words after a delay of 20-25 minutes. The scoring principle is based on the number of correctly recalled words during each learning trial and the delayed recall trial. The total score for the three learning trials and the delayed recall trial is calculated as well.

  baseline,the 2nd and 4th weekends after the start of the 4-week intervention,and the 4th weekend after the 4-week intervention.

• The Chinese Brief Cognitive Test（CBCT）

  Cognitive functioning was assessed using the C-BCT, which is based on the MATRICS Consensus Cognitive Battery (MCCB) . It has been validated in a large-scale study of schizophrenia patients and has shown good internal consistency and test-retest reliability . Also, additional studies in depression population provide further evidence of its reliability and validity supporting the robustness of this scale for assessing cognitive function in these clinical groups.

  baseline,the 2nd and 4th weekends after the start of the 4-week intervention,and the 4th weekend after the 4-week intervention.

• The Perceived Deficits Questionnaire for Depression（PDQ-D）

  The Chinese version of the Perceived Deficits Questionnaire for Depression (PDQ-D) has been validated for reliability and validity among patients with depression in China. The PDQ-D comprises 20 items, yielding a total score that ranges from 0 to 80. Higher scores indicate a greater severity of self-perceived cognitive symptoms. Demonstrating good reliability and validity, the questionnaire assesses patients' cognitive function across four dimensions: attention/concentration, prospective memory, retrospective memory, and planning and organization.

  baseline,2nd and 4th weekends after the start of the 4-week intervention,and the 4th weekend after the 4-week intervention.

Secondary Outcomes (13)

• Hamilton Depression Rating Scale-17（HDRS-17）

  baseline,1st,2nd,3rd and 4th weekends after the start of the 4-week intervention,the 4th weekend after the 4-week intervention.

• Generalized Anxiety Disorder-7（GAD-7）

  baseline,1st,2nd,3rd and 4th weekends after the start of the 4-week intervention,the 4th weekend after the 4-week intervention.

• Quick Inventory of Depressive Symptomatology-Self-Report（QIDS-SR）

  baseline,1st,2nd,3rd and 4th weekends after the start of the 4-week intervention,the 4th weekend after the 4-week intervention.

• Pittsburgh Sleep Quality Inventory（PSQI）

  baseline,1st,2nd,3rd and 4th weekends after the start of the 4-week intervention,the 4th weekend after the 4-week intervention.

• Young Mania Rating Scale（YMRS）

  baseline,1st,2nd,3rd and 4th weekends after the start of the 4-week intervention,the 4th weekend after the 4-week intervention.

Other Outcomes (1)

• Digit Symbol Substitution Test (DSST)

  screen

Study Arms (3)

Dim red light control intervention

PLACEBO COMPARATOR

Patients with selective serotonin reuptake inhibitors (SSRIs) or not will be subjected to red light (placebo) therapy. The light source intensity was set at \<200 lux and placed 0.5 meters away from the patient. Patients were exposed to the light source, staring at it for 2 seconds every 5 minutes. The red light therapy was administered for 40 minutes each day between 7:00 AM and 10:00 AM, lasting for four weeks.

Device: dim red light(placebo)

Bright Light Therapy(BLT) with Spectrally Optimized Light(SOL)

EXPERIMENTAL

In addition to administering dose-stable antidepressant medication (Selective Serotonin Reuptake Inhibitors, SSRIs) to patients with MDD-CI, they also received Bright Light Therapy(BLT) with Spectrally Optimized Light(SOL). The bright light source intensity is set at 10000 lux and placed 0.5 meters away from the patient. Every 5 minutes, patients are exposed to the light source, staring at it for 2 seconds each time. The bright light therapy was administered for 40 minutes each day between 7:00 AM and 10:00 AM, 6 days per week, lasting for four weeks.

Device: bright light

healthy control

NO INTERVENTION

Interventions

bright light DEVICE

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

Bright Light Therapy(BLT) with Spectrally Optimized Light(SOL)

dim red light(placebo) DEVICE

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

Dim red light control intervention

Eligibility Criteria

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

You may not qualify if:

• current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnosis of Major Depressive Disorder, first episode or recurrence;
• age 18-60 years; gender no-limited;
• the severity of MDD symptoms must be \>14 scores on the Hamilton Depression Rating Scale-17 (HAMD-17);
• with cognitive dysfunction currently,defined as a total score of ≤ 70 on the Digit Symbol Substitution Test (DSST);
• eligible patients have received Selective Serotonin Reuptake Inhibitors(SSRIs) at stable dosages for at least 1 week or not;
• education level above primary school, able to understand and cooperate in completing the study procedures;
• voluntarily participating in this study and sign the informed consent before enrollment.
• current or past diagnosis of any disorder other than major depressive disorder according to DSM-5 criteria;
• the scores on YMRS are \>8;
• Individuals who have undergone other intervention in addition to SSRIs whinin the past six month or now, or who plan to do that in one month;
• Individuals with strong self-blame, self-harm, or suicidal tendencies(HDRS-17 suicide item score ≥ 3)
• Individuals with severe physical illnesses, including heart failure, renal failure, severe liver dysfunction, hyperthyroidism, or hypothyroidism; Or a history of severe brain trauma or organic brain pathology (e.g., intracerebral hemorrhage, large-area cerebral infarction, encephalitis, epilepsy), as well as neurological diseases.
• Individuals with any degree of retinal pathology, including retinal dystrophy, age-related macular degeneration, diabetic retinopathy, cataracts, glaucoma, or other ocular diseases;
• Individuals with photosensitive conditions, such as systemic lupus erythematosus, porphyria, chronic photodermatitis, solar urticaria, or those currently receiving medications that may increase photosensitivity (e.g., phenothiazines, antimalarials, propranolol, hypericin, stimulants, or chronic treatment with nonsteroidal anti-inflammatory drugs).
• Pregnant or lactating women;

Sponsors & Collaborators

• Peking University Sixth Hospital: lead

Study Sites (2)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

Yan'an Third People's Hospital

Yanan, Shanxi, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Xiaozhen Lv, Ph.D

  Peking University Sixth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaozhen Lv, Ph.D

CONTACT

+8601062723705; lxz120300@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be coded according to the order of enrollment and randomly assigned to the experimental group or the control group by the random number method.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-01

Locations

CN (2)