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Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

2021年10月4日 更新者:Maurice-Andre Recanati、Wayne State University
Depression during pregnancy can cause fetal and maternal problems such as growth restriction, preterm labor, low birthweight, poor compliance and suicide. Since antidepressant medications have the potential to harm the baby, but since treatment of intrapartum depression is essential to maternal and fetal wellbeing, a non-pharmacological approach would be ideal. This project seeks to apply infrared light noninvasively to depressed patients during pregnancy in order to treat depressive symptoms through alteration of mitochondrial function and modulation of neural cell receptors.

研究概览

详细说明

Depression is common in pregnancy and affects about 70% of women and, for many women, pregnancy can lead to the first episode of major depression. Complications of intrapartum depression include intrauterine growth restriction, preterm labor, low birthweight, gestational diabetes, preeclampsia, decreased prenatal follow-up and suicide. For this reason, the standard of care has been to screen for depression during pregnancy and treat this illness, reducing maternal and fetal morbidity. Unfortunately, many first-line pharmacological approaches, such as serotonin reuptake inhibitors, may cause fetal malformations, persistent pulmonary hypertension and withdrawal syndrome. Thus, a non-pharmacological approach, without risk of fetal complications, would be ideal. The investigators propose a photobiomodulation based approach that uses non-ionizing near-infrared light (IRL) to upregulate mitochondrial function (through modulation of cytochrome c oxidase activity), which in-turn increase neurosteroid production and modulates GABAA receptor activity, thus alleviating depression. The investigators will perform a pilot study using IRL for the treatment of intrapartum depression. While other trials have shown success using IRL for depression in non-pregnant patients, this will confirm that photobiomodulation can modulate mitochondrial function and mitigate depressive symptoms compared to untreated controls in pregnancy by using real-time app-based depression scoring system and neuroimaging.

研究类型

介入性

注册 (预期的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Michigan
      • Detroit、Michigan、美国、48201
        • Detroit Medical Ceter

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Viable intrauterine pregnancy <16 weeks, PHQ-9 or Edinburg Score>10.

Exclusion Criteria:

  • pregnancy > 20 weeks
  • history of seizures
  • history of migraines
  • history of multiple sclerosis
  • prior traumatic brain injury
  • prior history of preeclampsia/toxemia
  • elevated blood pressure greater than 140/90
  • proteinuria (as defined by urine proteins >300 mg/24 h)
  • headaches
  • visual changes
  • right upper quadrant pain
  • history of bipolar disease
  • currently taking psychotropic medications (including antidepressants) and
  • prior history of attempted suicide

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
假比较器:No infrared light therapy
This arm does not receive any phototherapy
This is sham treatment. No light is actually given.
有源比较器:810 nm
Many clinical studies have used 810nm twice a week for 4 weeks. This is the standard.
Building upon the experience gathered from previous depression clinical trials, we will treat twice weekly for a total of 4-week duration consisting of 8 sessions. Each treatment will last 20 min and areas irradiated will include frontal and temporal areas bilaterally. Irradiance of 250 mW/cm2 with a fluence of 60 J/cm2.
实验性的:945nm
This wavelength has been chosen as a comparison to 810, to see if it works better.
Building upon the experience gathered from previous depression clinical trials, we will treat twice weekly for a total of 4-week duration consisting of 8 sessions. Each treatment will last 20 min and areas irradiated will include frontal and temporal areas bilaterally. Irradiance of 250 mW/cm2 with a fluence of 60 J/cm2.
实验性的:random frequency
A wavelength between 650-1100nm which is picked at random
Building upon the experience gathered from previous depression clinical trials, we will treat twice weekly for a total of 4-week duration consisting of 8 sessions. Each treatment will last 20 min and areas irradiated will include frontal and temporal areas bilaterally. Irradiance of 250 mW/cm2 with a fluence of 60 J/cm2.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in depression score
大体时间:Twice daily for the duration of the 4 week study
Using an App based approach, patients will enter their depression score
Twice daily for the duration of the 4 week study

次要结果测量

结果测量
措施说明
大体时间
Alteration in brain metabolism
大体时间:Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment
Functional MRI will be done to assess brain function and determine the effect of infrared light treatment on brain metabolics
Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年11月1日

初级完成 (预期的)

2022年9月1日

研究完成 (预期的)

2022年9月1日

研究注册日期

首次提交

2020年5月21日

首先提交符合 QC 标准的

2020年5月26日

首次发布 (实际的)

2020年5月27日

研究记录更新

最后更新发布 (实际的)

2021年10月5日

上次提交的符合 QC 标准的更新

2021年10月4日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IRB 20-05-2295

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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