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

Sponsored by Peking University Sixth Hospital

About this trial

Last updated a month ago

Study ID

7262156

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 60 Years

All Sexes

Trial Timing

Started a month ago

What is this trial about?

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.

What are the Participation Requirements?

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.