Clinical trial Recruiting at 2 sites Interventional Ages 18 to 60

Bright light therapy for cognitive problems in major depression

Official title: Efficacy of Bright Light Therapy on Cognitive Impairment in Major Depressive Disorder and Its Neuroimaging Mechanisms: Protocol for a Randomised Controlled Trial

Run by Peking University Sixth Hospital · NCT07508215 · Data updated 2026-11-12

A randomized trial will test whether bright light therapy can improve thinking problems in adults with major depressive disorder who are on SSRIs or off medications.

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment120 (estimated)
SponsorPeking University Sixth Hospital
Academic / other
Locations2 sites (Beijing, Beijing Municipality and 1 other locations)
StatusRecruiting
StartedApril 10, 2026
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedJuly 6, 2026
Trial IDNCT07508215 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–60 with MDD and verified cognitive impairment, on stable SSRI monotherapy for at least four weeks or currently medication-free.

Probably not a fit

Patients with unstable medication regimens, other primary psychiatric disorders, or contraindications to bright light exposure may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled study compares bright light therapy to a dim red light control over four weeks in adults with major depressive disorder and cognitive impairment. Participants must be on stable SSRI monotherapy for at least four weeks or be medication-free at enrollment. The study uses a 40-minute daily morning BLT session (7–10 am) six days per week, with follow-ups at 2, 4, and 8 weeks to assess cognitive performance and depressive and sleep symptoms. Neuroimaging will be used to explore hippocampus–dlPFC circuitry as a potential mediator of any cognitive benefits. The primary goal is to determine the efficacy and safety of BLT for cognitive impairment in MDD and to characterize associated neural mechanisms.

Why it matters

Potential benefit: If successful, BLT could offer a non-pharmacologic option to improve cognitive symptoms in MDD.

How similar studies have gone: Previous studies in related areas suggest potential cognitive and mood benefits with light-based therapies, but this specific protocol is relatively novel in linking cognitive outcomes with neuroimaging mechanisms.

Who can join: the full rules

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

1. MDD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-Ⅳ), first episode or recurrence, confirmed by an experienced psychiatrist using the Mini International Neuropsychiatric Interview.
2. Age between 18 and 60 years; and gender no-limited;
3. The severity of MDD symptoms must be ≥14 scores on the HAMD-17;
4. With CI currently, defined as a total score of \<70 on the SC;
5. A SSRI monotherapy at stable dosages for at least 4 weeks; or medication-free status;
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 MDD according to DSM-Ⅳ criteria;
2. The scores on the Young Mania Rating Scale (YMRS) are\>8;
3. The participants who have undergone other intervention in addition to SSRIs whinin the past 6 months or now, or who plan to do that in 1 month;
4. The participants with strong self-blame, self-harm, or suicidal risks (the HAMD-17 suicide item score of ≥3);
5. The participants 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. The participants with any degree of retinal pathology, including retinal dystrophy, age-related macular degeneration, diabetic retinopathy, cataracts, glaucoma, or other ocular diseases;
7. The participants 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. The participants with contraindications to MRI, such as the presence of non-MRI-safe metallic implants or claustrophobia;
10. The participants deem unsuitable for inclusion in this study by the investigator for other reasons.

Withdrawal and Termination Criteria:

1. The participants meet one of the exclusion criteria above after enrollment;
2. When the participants' treatment regimen need change;
3. The participants who fail to cooperate or voluntarily withdraw from the study;
4. Due to severe adverse events, the patients are unable to tolerate phototherapy;
5. The 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 between 18 and 60 years; and gender no-limited;
2. Without CI currently, defined as a total score of ≤ 70 on the SC;
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 past diagnosis of any psychiatric disorders, or history of substance/drug abuse or dependence;
2. Current or past diagnosis of 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. The participants with contraindications to MRI, such as the presence of non-MRI-safe metallic implants or claustrophobia.
6. The participants deem unsuitable for inclusion in this study by the investigator for other reasons.

Where it's running

  • Peking University Sixth Hospital
    Beijing, Beijing Municipality, China
    Recruiting
  • Yan'an Third People's Hospital
    Yanan, Shanxi, China
    Recruiting

Study contacts

  • Principal investigator: Xiaozhen Lv, Ph.D — Peking University Sixth Hospital
  • Study coordinator: Xiaozhen Lv, Ph.D
  • Email: lxz120300@163.com
  • Phone: +8601062723705

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.