跳至主要内容
临床试验/NCT07599124
NCT07599124已完成不适用

Is the Antidepressant Effect of Light Therapy for People With a Depressive Disorder Comparable in the Spring/Summer vs Autumn/Winter?

Geestelijke Gezondheidszorg Eindhoven (GGzE)1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
212
试验地点
1

研究概览

简要总结

This study investigates whether the antidepressant effects of bright light therapy (BLT) differ between the spring/summer season and the autumn/winter season in adults with depressive disorders. While BLT is an established treatment for seasonal affective disorder, increasing evidence suggests it may also be effective for non-seasonal depression. However, it remains unclear whether its effectiveness depends on seasonal variation in natural daylight exposure.

In this prospective study conducted in a routine clinical care setting, patients referred for depressive symptoms and a score of > 6 on the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) receive BLT in a structured "Light Café" environment. Participants undergo daily morning light therapy sessions (30 minutes at 10,000 lux) for at least one week, with possible extension up to three weeks based on treatment response. A delayed-start design is used, where a subset of participants begins treatment two weeks later, allowing comparison with the natural course of depressive symptoms.

Depressive symptoms are assessed using the QIDS-SR at baseline, during treatment, and at follow-up (6 weeks and 3 months post-treatment). Sleep quality, chronotype, circadian timing, and side effects are also measured.

The primary objective is to compare the effectiveness of BLT across seasons. Secondary objectives include evaluating the persistence of treatment effects, assessing the change in sleep quality and day-to-day sleep-wake pattern, and exploring whether outcomes vary by chronotype, circadian phase, and patient characteristics.

This study aims to inform whether BLT should be considered a year-round treatment option for depressive disorders and to better understand factors influencing individual treatment response.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older
  • Diagnosis of a depressive disorder (unipolar or bipolar), including both seasonal and non-seasonal depression
  • Currently indicated for bright light therapy
  • QIDS-SR score ≥ 6 at baseline
  • Able to provide informed consent
  • Sufficient proficiency in Dutch or English to complete questionnaires

排除标准

  • Current (hypo)manic or mixed episode
  • Current psychotic episode
  • Severe suicidal ideation requiring immediate intervention
  • Diagnosis of dementia
  • QIDS-SR score ≤ 5 at baseline
  • Age < 18 years
  • Inability to provide informed consent
  • Insufficient language proficiency to complete study questionnaires
  • Initiation, dose change, or switch of antidepressant medication within 3 weeks before or during light therapy
  • Long-term use of agomelatine
  • Relative Contraindications (require consultation with treating physician before participation):
  • Pregnancy (first trimester)
  • Diabetes or other systemic vascular diseases
  • Eye conditions associated with increased light sensitivity
  • Medication-Related Considerations:
  • Participants are advised not to start antibiotics during light therapy (existing courses should be completed prior to participation)
  • Participants are advised to discontinue use of photosensitizing medications or topical agents during treatment
  • Participants are asked to discontinue melatonin use during light therapy
  • A wash-out period of 1 month is required after discontinuation of melatonin or short-term agomelatine use before starting light therapy

研究者

发起方
Geestelijke Gezondheidszorg Eindhoven (GGzE)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Simons

Senior researcher

Geestelijke Gezondheidszorg Eindhoven (GGzE)

研究点 (1)

Loading locations...

相似试验