NCT04404231

Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Wayne State University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Depression
• Pregnancy Related
• Intrapartum Depression

Interventions

Type	Name	Description
RADIATION	Delivery of infrared light to the head	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.
OTHER	No Infrared treatment	This is sham treatment. No light is actually given.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-05-27
• Last updated: 2021-10-05

Locations

1 site across 1 country: United States