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Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

Primary Purpose

Depression, Pregnancy Related, Intrapartum Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delivery of infrared light to the head
No Infrared treatment
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring photobiomodulation, intrapartum depression, phototherapy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Detroit Medical Ceter

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Experimental

Experimental

Arm Label

No infrared light therapy

810 nm

945nm

random frequency

Arm Description

This arm does not receive any phototherapy

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

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

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

Outcomes

Primary Outcome Measures

Change in depression score
Using an App based approach, patients will enter their depression score

Secondary Outcome Measures

Alteration in brain metabolism
Functional MRI will be done to assess brain function and determine the effect of infrared light treatment on brain metabolics

Full Information

First Posted
May 21, 2020
Last Updated
October 4, 2021
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT04404231
Brief Title
Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
Official Title
Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Pregnancy Related, Intrapartum Depression
Keywords
photobiomodulation, intrapartum depression, phototherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The patient and the investigator are blinded
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No infrared light therapy
Arm Type
Sham Comparator
Arm Description
This arm does not receive any phototherapy
Arm Title
810 nm
Arm Type
Active Comparator
Arm Description
Many clinical studies have used 810nm twice a week for 4 weeks. This is the standard.
Arm Title
945nm
Arm Type
Experimental
Arm Description
This wavelength has been chosen as a comparison to 810, to see if it works better.
Arm Title
random frequency
Arm Type
Experimental
Arm Description
A wavelength between 650-1100nm which is picked at random
Intervention Type
Radiation
Intervention Name(s)
Delivery of infrared light to the head
Intervention Description
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
Other
Intervention Name(s)
No Infrared treatment
Intervention Description
This is sham treatment. No light is actually given.
Primary Outcome Measure Information:
Title
Change in depression score
Description
Using an App based approach, patients will enter their depression score
Time Frame
Twice daily for the duration of the 4 week study
Secondary Outcome Measure Information:
Title
Alteration in brain metabolism
Description
Functional MRI will be done to assess brain function and determine the effect of infrared light treatment on brain metabolics
Time Frame
Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maurice-Andre Recanati, MD
Phone
19173316203
Email
marecanati@gmail.com
Facility Information:
Facility Name
Detroit Medical Ceter
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31819453
Citation
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.
Results Reference
result
PubMed Identifier
30346890
Citation
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.
Results Reference
result

Learn more about this trial

Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

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