Depression, Intrapartum Depression, Pregnancy Related
Conditions
Keywords
photobiomodulation, intrapartum depression, phototherapy
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.
Interventions
RADIATIONDelivery 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.
OTHERNo Infrared treatment
This is sham treatment. No light is actually given.
Sponsors
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patient and the investigator are blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depression score | Twice daily for the duration of the 4 week study | Using an App based approach, patients will enter their depression score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alteration in brain metabolism | 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 |
Countries
United States
Contacts
Primary ContactMaurice-Andre Recanati, MD
Outcome results
None listed