Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

NCT ID: NCT04404231

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-09-01

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.

Conditions

Depression; Pregnancy Related; Intrapartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

No infrared light therapy

This arm does not receive any phototherapy

Group Type: SHAM_COMPARATOR

No Infrared treatment

Intervention Type: OTHER

This is sham treatment. No light is actually given.

810 nm

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

Group Type: ACTIVE_COMPARATOR

Delivery of infrared light to the head

Intervention Type: RADIATION

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.

945nm

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

Group Type: EXPERIMENTAL

Delivery of infrared light to the head

Intervention Type: RADIATION

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.

random frequency

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

Group Type: EXPERIMENTAL

Delivery of infrared light to the head

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

No Infrared treatment

This is sham treatment. No light is actually given.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Maurice-Andre Recanati

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Detroit Medical Ceter

Detroit, Michigan, United States

Countries

United States

Central Contacts

Maurice-Andre Recanati, MD

Role: CONTACT

marecanati@gmail.com

19173316203

References

Askalsky P, Iosifescu DV. Transcranial Photobiomodulation For The Management Of Depression: Current Perspectives. Neuropsychiatr Dis Treat. 2019 Nov 22;15:3255-3272. doi: 10.2147/NDT.S188906. eCollection 2019.

Reference Type: RESULT

PMID: 31819453 (View on PubMed)

Cassano P, Petrie SR, Mischoulon D, Cusin C, Katnani H, Yeung A, De Taboada L, Archibald A, Bui E, Baer L, Chang T, Chen J, Pedrelli P, Fisher L, Farabaugh A, Hamblin MR, Alpert JE, Fava M, Iosifescu DV. Transcranial Photobiomodulation for the Treatment of Major Depressive Disorder. The ELATED-2 Pilot Trial. Photomed Laser Surg. 2018 Dec;36(12):634-646. doi: 10.1089/pho.2018.4490. Epub 2018 Oct 20.

Reference Type: RESULT

PMID: 30346890 (View on PubMed)

Other Identifiers

IRB 20-05-2295

Identifier Type: -

Identifier Source: org_study_id