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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Feb 8, 2026 to Apr 10, 2026v3
  2. Primary endpoint(s) modifiedv2 Show 8 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Apr 1, 2026 to Feb 8, 2026
    • Interventions: bright light (Device), dim red light(placebo) (Device) to BLT (Device), DRL (Device)
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 13 to 15
    • Study description expanded, about 24 words
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 6 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study aims to validate the therapeutic efficacy and safety of bright light therapy (BLT) 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 participants with CI and examine the mediating effect of the HPC-dlPFC neural circuit on CI induced by BLT treatment in MDD participants. MDD participants will be required to only receive selective serotonin reuptake inhibitors (SSRIs) as monotherapy for at least four weeks, or medication-free status before enrollment. Eligible 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 (DRL). The intervention will last for four weeks, 6 days per week, with 40 minutes each day between 7 am and 10 am. The MDD participants will be followed once in the end of each week during the 4-week intervention and in the end of the 4th week after intervention. Demographic information will be collected at baseline; cognitive function will be evaluated at baseline, weeks 2, 4, and 8 after intervention beginning; and other symptoms such as depression, anxiety and sleep were assessed at baseline, weeks 1, 2, 3, 4, and 8 after intervention beginning. Moreover, structural and functional MRI scans will be made at baseline and post-intervention. During the intervention, MDD participants will be required to keep a record of daily light exposure duration and complete the daily sleep diary as well.
Trial Details
NCT Number NCT07508215
Lead Sponsor Peking University Sixth Hospital
Conditions
(from sponsor)		 Major Depressive Disorder (MDD), Neuroimaging, Bright Light Treatment, Cognitive Impairment
Related terms Cognitive Dysfunction, Major Depressive Disorder
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov