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临床试验/NCT04385394
NCT04385394已完成不适用

Bright Light Therapy as Augmentation of Depressive Symptoms as Measured by Changes in Beck Depression Inventory, Hamilton Rating Scale for Depression and Outcome Questionnaire-45 on Acute Psychiatric Floor

State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月30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
100
试验地点
1
主要终点
depression scores

研究概览

简要总结

The purpose of this study is to explore if Bright Light Therapy (BLT) as augmentation of depression treatment on an acute psychiatric floor is feasible, helps alleviate depressive symptoms, improve functioning, and decrease length of stay on the psychiatric floor.

详细描述

Background:

Bright light therapy is an evidence-based treatment for seasonal depression (SAD), recently there is evidence that it has some efficacy in nonseasonal major depressive disorder (MDD) when used together with antidepressants.

BLT works via the patient's eyes through

  1. Melanopsin (Intrinsic Photo receptor ganglion Cells)
  2. Suprachiasmatic Nucleus (SCN, master clock) which follows a rhythmic change
  3. Serotonin

A number of studies showed seasonal changes in serotonergic parameters, including brain serotonin concentration and turnover. There were no research on using the BLT on the acute inpatient floor to augment the antidepressant treatment. Yet, there is a great need for such augmentation as for Selective Serotonin Reuptake Inhibitors (SSRI) to take full effect 4-6 weeks needed. Moreover, patients with depression often do not spend enough time on the direct sun light, which exacerbate and prolong their depressed mood. The augmentation with the BLT on the acute psychiatric floor will help the antidepressant work, expedite the recovery, and potentially shortens the length of stay in the hospital, which in turn will lead to an economic saving and faster return of the patient into the community and to the workforce.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • depressive symptoms on BDI (score 14 and above - eligible for BLT) and/or
  • depressive symptoms on HAMD-17 (score 8 and above)

排除标准

  • no report of depressive symptoms; manic symptoms, acute psychosis, schizophrenia, schizoaffective disorder, impending Electro Convulsive Therapy (ECT), retinal risk factors, lupus, bright light sensitivity, glaucoma, cataracts, retinal detachment, retinopathy, patients on photosensitizing meds (tetracycline, sulfonamides, psoralens, and phenothiazine antipsychotics)

结局指标

主要结局

depression scores

时间窗: 7 days

changes in depression scores, administered before light therapy and prior to discharge (corresponds to the last session of light therapy)

Functioning scores

时间窗: 7 days

symptoms distress, interpersonal functioning, social role

次要结局

  • length of stay(7 days)

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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