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Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404231
Recruitment Status : Unknown
Verified October 2021 by Maurice-Andre Recanati, Wayne State University.
Recruitment status was:  Not yet recruiting
First Posted : May 27, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Maurice-Andre Recanati, Wayne State University

Tracking Information
First Submitted Date  ICMJE May 21, 2020
First Posted Date  ICMJE May 27, 2020
Last Update Posted Date October 5, 2021
Estimated Study Start Date  ICMJE November 1, 2021
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Depression
  • Pregnancy Related
  • Intrapartum Depression
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 26, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04404231
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Maurice-Andre Recanati, Wayne State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Wayne State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wayne State University
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP