Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
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
- 是
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
Maurice-Andre Recanati
Assistant Professor
Wayne State University
