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

Tracking Information

• First Submitted Date: May 21, 2020
• First Posted Date: May 27, 2020
• Last Update Posted Date: October 5, 2021
• Estimated Study Start Date: November 1, 2021
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2020)

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

Original Primary Outcome Measures (submitted: May 26, 2020)

Improvement 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

Current Secondary Outcome Measures (submitted: July 29, 2020)

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

Original Secondary Outcome Measures (submitted: May 26, 2020)

Improvement of 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
• Official Title: Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Depression
• Pregnancy Related
• Intrapartum Depression

Intervention

• 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.
• Other: No Infrared treatment
  This is sham treatment. No light is actually given.

Study Arms

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

Publications *

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 26, 2020): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2022
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant women

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04404231
• Other Study ID Numbers: IRB 20-05-2295
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Maurice-Andre Recanati, Wayne State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Wayne State University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Wayne State University
• Verification Date: October 2021