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临床试验/NCT04404231
NCT04404231Unknown不适用

Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

Wayne State University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Change in depression score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The patient and the investigator are blinded

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Change in depression score

时间窗: Twice daily for the duration of the 4 week study

Using an App based approach, patients will enter their depression score

次要结局

  • Alteration in brain metabolism(Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maurice-Andre Recanati

Assistant Professor

Wayne State University

研究点 (2)

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