Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

Depression Clinical Trial

Official title:

Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04404231
• Other study ID #: IRB 20-05-2295
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: October 2021
• Source: Wayne State University
• Contact: Maurice-Andre Recanati, MD
• Phone: 19173316203
• Email: marecanati[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Intrapartum Depression
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
United States	Detroit Medical Ceter	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

References & 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. Review. — View 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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Alteration in brain metabolism	Functional MRI will be done to assess brain function and determine the effect of infrared light treatment on brain metabolics	Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment