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NCT07508215
Efficacy of Spectrally Optimized Light on Cognitive Impairment in Major Depressive Disorder and Its Neuroimaging Mechanisms
NA trial testing bright light in Major Depressive Disorder (MDD) in 120 participants. Not yet recruiting.
31 December 2028
Quick facts
| Lead sponsor | Peking University Sixth Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 April 2026 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2028 |
| Sites | 2 locations across China |
Drugs / interventions tested
- bright light
- dim red light(placebo)
Conditions studied
- Major Depressive Disorder (MDD) — all drugs for Major Depressive Disorder (MDD) →
- Neuroimaging — all drugs for Neuroimaging →
- Bright Light Treatment — all drugs for Bright Light Treatment →
- Cognitive Impairment — all drugs for Cognitive Impairment →
Sponsor
Peking University Sixth Hospital
Who can join
Adults 18 to 60, any sex, with Major Depressive Disorder (MDD) or Neuroimaging. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07508215
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07508215 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University Sixth Hospital
- Last refreshed: 2 April 2026
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