ClinicalTrials.gov
History of Changes for Study: NCT04404231
Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
Latest version (submitted October 4, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 26, 2020 None (earliest Version on record)
2 July 29, 2020 Study Status, Outcome Measures, Study Description, Study Design and Oversight
3 October 4, 2021 Recruitment Status and Study Status
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Study NCT04404231
Submitted Date:  May 26, 2020 (v1)
Open or close this module Study Identification
Unique Protocol ID: IRB 20-05-2295
Brief Title: Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
Official Title: Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Not yet recruiting
Study Start: July 1, 2020
Primary Completion: July 1, 2022 [Anticipated]
Study Completion: July 1, 2022 [Anticipated]
First Submitted: May 21, 2020
First Submitted that
Met QC Criteria:		 May 26, 2020
First Posted: May 27, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:		 May 26, 2020
Last Update Posted: May 27, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Wayne State University
Responsible Party: Principal Investigator
Investigator: Maurice-Andre Recanati
Official Title: Assistant Professor
Affiliation: Wayne State University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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 their 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 their 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. We propose here 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. We 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, we 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.
Open or close this module Conditions
Conditions: Depression
Pregnancy Related
Intrapartum Depression
Keywords: photobiomodulation
intrapartum depression
phototherapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Early Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Sham Comparator: No infrared light therapy
This arm does not receive any phototherapy
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: Female
Gender Based: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Maurice-Andre Recanati, MD
Telephone: 19173316203
Email: marecanati@gmail.com
Locations: United States, Michigan
Detroit Medical Ceter
Detroit, Michigan, United States, 48201
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: [Study 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. PubMed 31819453
[Study Results] 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. PubMed 30346890
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