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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

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. |
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404231
Contact: Maurice-Andre Recanati, MD | 19173316203 | marecanati@gmail.com |
United States, Michigan | |
Detroit Medical Ceter | |
Detroit, Michigan, United States, 48201 |
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 Key Record Dates |
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 |
photobiomodulation intrapartum depression phototherapy |
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |