NCT04404231

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

May 21, 2020

Last Update Submit

October 4, 2021

Conditions

DepressionPregnancy RelatedIntrapartum Depression

Keywords

photobiomodulationintrapartum depressionphototherapy

Outcome Measures

Primary Outcomes (1)

  • Change in depression score

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

    Twice daily for the duration of the 4 week study

Secondary Outcomes (1)

  • Alteration in brain metabolism

    Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment

Study Arms (4)

No infrared light therapy

SHAM COMPARATOR

This arm does not receive any phototherapy

Other: No Infrared treatment

810 nm

ACTIVE COMPARATOR

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

Radiation: Delivery of infrared light to the head

945nm

EXPERIMENTAL

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

Radiation: Delivery of infrared light to the head

random frequency

EXPERIMENTAL

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

Radiation: Delivery of infrared light to the head

Interventions

Delivery of infrared light to the headRADIATION

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.

810 nm945nmrandom frequency
No Infrared treatmentOTHER

This is sham treatment. No light is actually given.

No infrared light therapy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Viable intrauterine pregnancy \<16 weeks, PHQ-9 or Edinburg Score\>10.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Medical Ceter

Detroit, Michigan, 48201, United States

Location

Related Publications (2)

  • 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.

    PMID: 31819453RESULT

  • 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.

    PMID: 30346890RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Maurice-Andre Recanati, MD

CONTACT

19173316203marecanati@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patient and the investigator are blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

November 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

October 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)