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

New light therapy trial for depression-related cognitive issues in Beijing

NCT: NCT07508215 · Status: NOT YET RECRUITING · Phase: N/A · Sponsor: Peking University Sixth Hospital · Started: 2026-04-01 · Est. Completion: 2028-12-31

Plain English Summary

Efficacy of Spectrally Optimized Light on Cognitive Impairment in Major Depressive Disorder and Its Neuroimaging Mechanisms is a Not Applicable clinical trial sponsored by Peking University Sixth Hospital studying Major Depressive Disorder (MDD), Neuroimaging, Bright Light Treatment, Cognitive Impairment. This study tests a special type of light therapy to see if it can improve thinking problems in people with major depression. It is for adults aged 18-60 diagnosed with major depressive disorder who are experiencing cognitive difficulties. Participants will use a light box for four weeks, either with bright, optimized light or a dim red light as a comparison, and undergo regular assessments. Current treatments for cognitive issues in depression include medication and psychotherapy; this study explores light therapy as a potential alternative or add-on. The trial aims to enroll 120 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18-60 with a diagnosis of major depressive disorder and significant cognitive impairment (difficulty with tasks like the Digit Symbol Substitution Test). Individuals currently taking stable doses of SSRI antidepressants or not on medication are eligible. People with other psychiatric disorders, severe physical illnesses, certain eye conditions, photosensitivity, or contraindications to MRI scans cannot participate. Individuals with severe suicidal tendencies or those undergoing other non-approved interventions may also be excluded. This trial is studying Major Depressive Disorder (MDD), Neuroimaging, Bright Light Treatment, Cognitive Impairment, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how well participants can focus, remember information, and process speed, indicating potential improvements in daily cognitive abilities. The specific primary outcome measures are: Stroop Color-Word Test (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 (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） (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） (baseline,2nd and 4th weekends after the start of the 4-week intervention,and the 4th weekend after the 4-week intervention.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a significant unmet need by investigating a novel light therapy approach to improve cognitive function, a common and debilitating symptom in major depressive disorder. This research targets Major Depressive Disorder (MDD), Neuroimaging, Bright Light Treatment, Cognitive Impairment, where improved treatment options are needed.

Investor Insight

This trial signals potential innovation in non-pharmacological treatments for depression-related cognitive impairment, a large market with a need for effective solutions.

Is This Trial Right for Me?

Ask your doctor if this light therapy is appropriate for you, especially considering your current medications and any eye or skin conditions. Participation involves using a light box daily for four weeks and attending regular clinic visits for assessments, including brain scans. You will need to keep a daily log of your light exposure and sleep patterns. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

The inclusion and exclusion criteria for MDD patients. 1、Inclusion Criteria:

1. current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnosis of Major Depressive Disorder, first episode or recurrence;
2. age 18-60 years; gender no-limited;
3. the severity of MDD symptoms must be \>14 scores on the Hamilton Depression Rating Scale-17 (HAMD-17);
4. with cognitive dysfunction currently,defined as a total score of ≤ 70 on the Digit Symbol Substitution Test (DSST);
5. eligible patients have received Selective Serotonin Reuptake Inhibitors(SSRIs) at stable dosages for at least 1 week or not;
6. education level above primary school, able to understand and cooperate in completing the study procedures;
7. voluntarily participating in this study and sign the informed consent before enrollment.

2、Exclusion Criteria:

1. current or past diagnosis of any disorder other than major depressive disorder according to DSM-5 criteria;
2. the scores on YMRS are \>8;
3. 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;
4. Individuals with strong self-blame, self-harm, or suicidal tendencies(HDRS-17 suicide item score ≥ 3)
5. 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.
6. Individuals with any degree of retinal pathology, including retinal dystrophy, age-related macular degeneration, diabetic retinopathy, cataracts, glaucoma, or other ocular diseases;
7. 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).
8. Pregnant or lactating women;
9. Individuals with contraindications to magnetic resonance imaging (MRI), such as the presence of non-MRI-safe metallic implants or claustrophobia.
10. Individuals deem unsuitable for inclusion in this study by the investigator for other reasons.

Withdrawal and Termination Criteria：

1. Participants meet one of the exclusion criteria above after enrollment
2. current individuals' treatment regimen need change;
3. Participants who fail to cooperate or voluntarily withdraw from the study;
4. Due to severe adverse events, participants are unable to tolerate phototherapy.
5. Participants who fail to adhere to the study protocol intervention for three consecutive days or for a cumulative duration exceeding seven days;
6. Cancellation of the study.

The inclusion and exclusion criteria for Health controls

1\. Inclusion criteria

1. age 18-60 years; gender no-limited; and right-handed;
2. without cognitive dysfunction currently,defined as a total score of ≤ 70 on the Digit Symbol Substitution Test (DSST)
3. education level above primary school, able to understand and cooperate in completing the study procedures;
4. voluntarily participating in this study and sign the informed consent before enrollment.

2.Exclusion criteria

1. Current or lifetime diagnosis of any psychiatric disorders, or history of substance/drug abuse or dependence;
2. Currently or previously diagnosed with severe somatic diseases, such as heart failure, renal failure, severe liver dysfunction, or hyperthyroidism/hypothyroidism;
3. history of severe traumatic brain injury or organic brain lesions;
4. Pregnant or lactating women;
5. Individuals with contraindications to magnetic resonance imaging (MRI), such as the presence of non-MRI-safe metallic implants or claustrophobia.
6. Individuals deem unsuitable for inclusion in this study by the investigator for other reasons.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07508215?

NCT07508215 is a Not Applicable INTERVENTIONAL study titled "Efficacy of Spectrally Optimized Light on Cognitive Impairment in Major Depressive Disorder and Its Neuroimaging Mechanisms." It is currently not yet recruiting and is sponsored by Peking University Sixth Hospital. The trial targets enrollment of 120 participants.

What conditions does NCT07508215 study?

This trial investigates treatments for Major Depressive Disorder (MDD), Neuroimaging, Bright Light Treatment, Cognitive Impairment. The primary condition under study is Major Depressive Disorder (MDD).

What treatments are being tested in NCT07508215?

The interventions being studied include: bright light (DEVICE), dim red light(placebo) (DEVICE). Using a hybrid white light box with independent intellectual property rights, with an intensity of 10000lux and a main wavelength of 476.4nm

What does Not Applicable mean for NCT07508215?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07508215?

This trial is currently "Not Yet Recruiting." It started on 2026-04-01. The estimated completion date is 2028-12-31.

Who is sponsoring NCT07508215?

NCT07508215 is sponsored by Peking University Sixth Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07508215?

The trial aims to enroll 120 participants. The trial has not yet started recruiting.

How is NCT07508215 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT07508215?

The primary outcome measures are: Stroop Color-Word Test (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 (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） (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） (baseline,2nd and 4th weekends after the start of the 4-week intervention,and the 4th weekend after the 4-week intervention.). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07508215 being conducted?

This trial is being conducted at 2 sites, including Beijing, Beijing Municipality; Yanan, Shanxi (China).

Where can I find official information about NCT07508215?

The official record for NCT07508215 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07508215. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07508215 testing in simple terms?

This study tests a special type of light therapy to see if it can improve thinking problems in people with major depression. It is for adults aged 18-60 diagnosed with major depressive disorder who are experiencing cognitive difficulties.

Why is this trial significant?

This trial addresses a significant unmet need by investigating a novel light therapy approach to improve cognitive function, a common and debilitating symptom in major depressive disorder.

What are the potential risks of participating in NCT07508215?

Potential side effects of light therapy can include headaches, eye strain, or temporary mood changes. There is a risk of experiencing mild skin irritation or discomfort from the light exposure. As with any study involving MRI, there are risks associated with the magnetic field and contrast agents (if used). As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07508215?

Ask your doctor if this light therapy is appropriate for you, especially considering your current medications and any eye or skin conditions. Participation involves using a light box daily for four weeks and attending regular clinic visits for assessments, including brain scans. You will need to keep a daily log of your light exposure and sleep patterns. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07508215 signal from an investment perspective?

This trial signals potential innovation in non-pharmacological treatments for depression-related cognitive impairment, a large market with a need for effective solutions. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will use a light box for four weeks, either with bright, optimized light or a dim red light as a comparison, and undergo regular assessments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Major Depressive Disorder (MDD) Trials

View all Major Depressive Disorder (MDD) clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.