A Double-blinded, Randomized Placebo-controlled Trial of 40 Hz Light Neurostimulation Therapy for Patients With Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Depression severity measured by Hamilton Depression Rating sub-scale (HAM-D6)
研究概览
简要总结
Recent research in mice models of Alzheimer's disease (AD) has demonstrated that one hour per day of exposure to 40 Hz flickering light therapy can halt the disease's progression, and improve cognition and memory. Moreover, recent data suggest that 40 Hz light stimulation may induce neuroplasticity and reduce neuroinflammation.
In this study, the investigators aim to evaluate the antidepressant effects of 40 Hz light stimulation in Major Depressive Disorder (MDD). Patients will be exposed to 40 Hz invisible spectral flickering light (active setting) or continuous non-flickering white light (sham setting) in a home setting for 1 hour each day.
详细描述
Major depression is a major societal challenge worldwide and a substantial proportion of patients do not attain remission. Major depressive disorder (MDD) bears several key neurobiological similarities with Alzheimer's Disease, namely cognitive deficits, impaired neuroplasticity, neurodegeneration, and neuroinflammation. Inducing neuroplasticity and reducing neuroinflammation are thought to be key cellular targets in the treatment of MDD. However, 40 Hz light stimulation research in the context of MDD is limited.
In this double-blinded, randomized placebo-controlled trial the primary objective is to investigate the antidepressant effect of a non-invasive neurostimulation therapy using a 40 Hz masked flickering light. This study utilizes a novel way of masking light by alternating the spectral composition of white light, resulting in the flicker unnoticeable to human perception.
The primary outcome measure of this study is the estimated difference in the Hamilton Depression Rating sub-scale (HAM-D6) scores between groups at week 6. Furthermore, investigators want to assess whether 40 Hz masked flickering light therapy produces a similar early shift in neural and cognitive response to emotional information seen with antidepressant therapy and whether this predicts treatment efficacy. Suicidal ideation, sleep patterns, and quality of life will be also investigated in order to evaluate the 40 Hz masked flickering light stimulation effects on other symptoms of depression. Explorative analysis of the EEG data will be performed from baseline to week 6 for the further development and validation of EEG-based biomarkers.
A total of 60 participants will be enrolled for a six weeks treatment period followed by a two weeks follow-up period. Participants will be recruited from a psychotherapeutic outpatient unit. Medication should be unchanged for the last 4 weeks and during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 18 and 75 years of age.
- •Subjects with a diagnosis of major depressive episode and currently experiencing a depressive episode according to DSM-5
- •Subjects with an MDI score > 21 at screening
- •Subjects on stable medication and/or psychotherapy for at least 4 weeks before starting the trial.
- •Subjects, who are willing to comply with the scheduled plan and are able to use the device for 1 hour per day for 6 weeks.
- •Subjects who can understand the oral and written study information and willing to sign an informed consent.
排除标准
- •Subjects with a history of photosensitive migraines and/or epileptic seizures
- •Subjects with a known eye disorder that might be sensitive to light treatment.
- •Subjects with a known history of bipolar disorder according to DSM-5 criteria
- •Subjects with suicidal ideation corresponding to a score of 2 or more on the HAM-D 17 scale item 3 or if the patient or investigator is uncertain of the degree of suicidal risk
- •Subjects with current psychotic symptoms. However, subjects with a prior psychotic depression or subjects with an actual psychotic depression episode that at the time of informed consent no longer fulfills the psychosis criteria are allowed to participate.
- •Subjects with current drug or alcohol dependence based on their medical records or the M.I.N.I. interview.
- •Subjects with a known history of borderline personality disorder
- •Subjects currently enrolled in another investigational treatment study.
- •Subjects with progressive neurodegenerative or neoplastic disease.
- •Subjects who are unable to understand the study procedures or handling of the NSS device.
- •Subjects who are pregnant at the time of inclusion or unsafe contraception in women of fertile age
研究组 & 干预措施
Active Neurostimulation System (NSS)
Exposure to the NSS device set to 40 Hz invisible spectral flicker 1 hour a day
Sham Neurostimulation System (NSS)
Exposure to the NSS device set to continuous color-matched white light for 1 hour a day
结局指标
主要结局
Depression severity measured by Hamilton Depression Rating sub-scale (HAM-D6)
时间窗: Baseline and week 6
The HAM-D6 scale is designed to rate the severity of depression by a healthcare professional. The assessment scale contains 6 items pertaining to the symptoms of depression experienced over the week. The primary endpoint is the mean difference in scores between treatments at baseline and week 6. The score range is from, 0-24 (24=highest depression level).
次要结局
- Cognition measured by Screen for Cognitive Impairment in Psychiatry (SCIP)(Baseline, week 1 and 6)
- Sleep timing(Baseline, week 3, 6 and 8)
- Self-reported depression symptoms measured by Major Depression Inventory (MDI)(Baseline, week 1, 3, 6 and 8.)
- Cognition measured by Facial Expression Recognition Test (FERT)(Baseline, week 1 and 6)
- Quality of Life measured by WHO quality of life index (WHO-5)(Baseline, week 3,6 and 8)
- Cognition measured by Emotional Categorization and Memory test (ECMT)(Baseline, week 1 and 6)
- Sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)(Baseline, week 3, 6 and 8)
- Cognition measured by Trail Making Test B (TMT- B)(Baseline, week 1 and 6)
- Sleep duration(Baseline, week 3, 6 and 8)
研究者
Klaus Martiny
Professor, Head of NID-Group
University Hospital Bispebjerg and Frederiksberg