Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

Conditions
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Depression, Pregnancy Related, Intrapartum Depression

Intervention / Treatment
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* Radiation: Delivery of infrared light to the head
* Other: No Infrared treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: No infrared light therapy<br>This arm does not receive any phototherapy | Other: No Infrared treatment<br>* This is sham treatment. No light is actually given.<br>|
| Active Comparator: 810 nm<br>Many clinical studies have used 810nm twice a week for 4 weeks. This is the standard. | Radiation: Delivery of infrared light to the head<br>* 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.<br>|
| Experimental: 945nm<br>This wavelength has been chosen as a comparison to 810, to see if it works better. | Radiation: Delivery of infrared light to the head<br>* 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.<br>|
| Experimental: random frequency<br>A wavelength between 650-1100nm which is picked at random | Radiation: Delivery of infrared light to the head<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression score | Using an App based approach, patients will enter their depression score | Twice daily for the duration of the 4 week study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration in brain metabolism | Functional MRI will be done to assess brain function and determine the effect of infrared light treatment on brain metabolics | Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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photobiomodulation, intrapartum depression, phototherapy