Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

• ClinicalTrials.gov Identifier: NCT04404231
• Recruitment Status: Unknown
• First Posted: May 27, 2020
• Last Update Posted: October 5, 2021
• Sponsor: Wayne State University
• Information provided by (Responsible Party): Maurice-Andre Recanati, Wayne State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression; Pregnancy Related; Intrapartum Depression	Radiation: Delivery of infrared light to the head; Other: No Infrared treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The patient and the investigator are blinded
• Primary Purpose: Treatment
• Official Title: Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
• Estimated Study Start Date: November 1, 2021
• Estimated Primary Completion Date: September 1, 2022
• Estimated Study Completion Date: September 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in depression score [ Time Frame: Twice daily for the duration of the 4 week study ]
   Using an App based approach, patients will enter their depression score

Secondary Outcome Measures :

1. Alteration in brain metabolism [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant women
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Maurice-Andre Recanati, MD; 19173316203; marecanati@gmail.com

Locations

United States, Michigan

Detroit Medical Ceter

Detroit, Michigan, United States, 48201

Sponsors and Collaborators

Wayne State University

More Information

Publications of Results:

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.

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.

• Responsible Party: Maurice-Andre Recanati, Assistant Professor, Wayne State University
• ClinicalTrials.gov Identifier: NCT04404231
• Other Study ID Numbers: IRB 20-05-2295
• First Posted: May 27, 2020
• Last Update Posted: October 5, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maurice-Andre Recanati, Wayne State University:

photobiomodulation; intrapartum depression; phototherapy

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders