Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

Wayne State University

Status: Unknown

Conditions: Pregnancy Related; Intrapartum Depression; Depression

Treatments: Other: No Infrared treatment; Radiation: Delivery of infrared light to the head

Study type: Interventional

Funder types: Other

Identifiers

NCT04404231

IRB 20-05-2295

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups

No infrared light therapy

Sham Comparator group

Description:

This arm does not receive any phototherapy

Treatment:

Other: No Infrared treatment

810 nm

Active Comparator group

Description:

Many clinical studies have used 810nm twice a week for 4 weeks. This is the standard.

Treatment:

Radiation: Delivery of infrared light to the head

945nm

Experimental group

Description:

This wavelength has been chosen as a comparison to 810, to see if it works better.

Treatment:

Radiation: Delivery of infrared light to the head

random frequency

Experimental group

Description:

A wavelength between 650-1100nm which is picked at random

Treatment:

Radiation: Delivery of infrared light to the head