Clinical trial NCT04404231: Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
Official title: Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Pregnancy Related
Intrapartum Depression
Keywords: photobiomodulation
intrapartum depression
phototherapy
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in depression score
timeFrame: Twice daily for the duration of the 4 week study
Secondary outcomes:
measure: Alteration in brain metabolism
timeFrame: Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Medical Ceter
state: Michigan
Study officials:
References:
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.
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.