Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

Not Applicable

• Conditions: Pregnancy Related; Depression; Intrapartum Depression
• Interventions: Radiation: Delivery of infrared light to the head; Other: No Infrared treatment

• Registration Number: NCT04404231
• Lead Sponsor: Wayne State University

Brief 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.

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05
• Study Start: 2021-11-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
810 nm	Delivery of infrared light to the head	Many clinical studies have used 810nm twice a week for 4 weeks. This is the standard.
945nm	Delivery of infrared light to the head	This wavelength has been chosen as a comparison to 810, to see if it works better.
random frequency	Delivery of infrared light to the head	A wavelength between 650-1100nm which is picked at random
No infrared light therapy	No Infrared treatment	This arm does not receive any phototherapy

Primary Outcome Measures

Name	Time	Method
Change in depression score	Twice daily for the duration of the 4 week study	Using an App based approach, patients will enter their depression score

Secondary Outcome Measures

Name	Time	Method
Alteration in brain metabolism	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

Trial Locations

Locations (1)

Detroit Medical Ceter; 🇺🇸 Detroit, Michigan, United States