<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04404231</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 20-05-2295</org_study_id>
    <nct_id>NCT04404231</nct_id>
  </id_info>
  <brief_title>Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation</brief_title>
  <official_title>Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wayne State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression during pregnancy can cause fetal and maternal problems such as growth restriction,&#xD;
      preterm labor, low birthweight, poor compliance and suicide. Since antidepressant medications&#xD;
      have the potential to harm the baby, but since treatment of intrapartum depression is&#xD;
      essential to maternal and fetal wellbeing, a non-pharmacological approach would be ideal.&#xD;
      This project seeks to apply infrared light noninvasively to depressed patients during&#xD;
      pregnancy in order to treat depressive symptoms through alteration of mitochondrial function&#xD;
      and modulation of neural cell receptors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is common in pregnancy and affects about 70% of women and, for many women,&#xD;
      pregnancy can lead to the first episode of major depression. Complications of intrapartum&#xD;
      depression include intrauterine growth restriction, preterm labor, low birthweight,&#xD;
      gestational diabetes, preeclampsia, decreased prenatal follow-up and suicide. For this&#xD;
      reason, the standard of care has been to screen for depression during pregnancy and treat&#xD;
      this illness, reducing maternal and fetal morbidity. Unfortunately, many first-line&#xD;
      pharmacological approaches, such as serotonin reuptake inhibitors, may cause fetal&#xD;
      malformations, persistent pulmonary hypertension and withdrawal syndrome. Thus, a&#xD;
      non-pharmacological approach, without risk of fetal complications, would be ideal. The&#xD;
      investigators propose a photobiomodulation based approach that uses non-ionizing&#xD;
      near-infrared light (IRL) to upregulate mitochondrial function (through modulation of&#xD;
      cytochrome c oxidase activity), which in-turn increase neurosteroid production and modulates&#xD;
      GABAA receptor activity, thus alleviating depression. The investigators will perform a pilot&#xD;
      study using IRL for the treatment of intrapartum depression. While other trials have shown&#xD;
      success using IRL for depression in non-pregnant patients, this will confirm that&#xD;
      photobiomodulation can modulate mitochondrial function and mitigate depressive symptoms&#xD;
      compared to untreated controls in pregnancy by using real-time app-based depression scoring&#xD;
      system and neuroimaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">November 1, 2021</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The patient and the investigator are blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depression score</measure>
    <time_frame>Twice daily for the duration of the 4 week study</time_frame>
    <description>Using an App based approach, patients will enter their depression score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alteration in brain metabolism</measure>
    <time_frame>Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment</time_frame>
    <description>Functional MRI will be done to assess brain function and determine the effect of infrared light treatment on brain metabolics</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Depression</condition>
  <condition>Pregnancy Related</condition>
  <condition>Intrapartum Depression</condition>
  <arm_group>
    <arm_group_label>No infrared light therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This arm does not receive any phototherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>810 nm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Many clinical studies have used 810nm twice a week for 4 weeks. This is the standard.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>945nm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This wavelength has been chosen as a comparison to 810, to see if it works better.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>random frequency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A wavelength between 650-1100nm which is picked at random</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Delivery of infrared light to the head</intervention_name>
    <description>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.</description>
    <arm_group_label>810 nm</arm_group_label>
    <arm_group_label>945nm</arm_group_label>
    <arm_group_label>random frequency</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Infrared treatment</intervention_name>
    <description>This is sham treatment. No light is actually given.</description>
    <arm_group_label>No infrared light therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Viable intrauterine pregnancy &lt;16 weeks, PHQ-9 or Edinburg Score&gt;10.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy &gt; 20 weeks&#xD;
&#xD;
          -  history of seizures&#xD;
&#xD;
          -  history of migraines&#xD;
&#xD;
          -  history of multiple sclerosis&#xD;
&#xD;
          -  prior traumatic brain injury&#xD;
&#xD;
          -  prior history of preeclampsia/toxemia&#xD;
&#xD;
          -  elevated blood pressure greater than 140/90&#xD;
&#xD;
          -  proteinuria (as defined by urine proteins &gt;300 mg/24 h)&#xD;
&#xD;
          -  headaches&#xD;
&#xD;
          -  visual changes&#xD;
&#xD;
          -  right upper quadrant pain&#xD;
&#xD;
          -  history of bipolar disease&#xD;
&#xD;
          -  currently taking psychotropic medications (including antidepressants) and&#xD;
&#xD;
          -  prior history of attempted suicide&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maurice-Andre Recanati, MD</last_name>
    <phone>19173316203</phone>
    <email>marecanati@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Detroit Medical Ceter</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <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>
    <PMID>31819453</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>30346890</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Maurice-Andre Recanati</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>photobiomodulation</keyword>
  <keyword>intrapartum depression</keyword>
  <keyword>phototherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04404231
org study id: IRB 20-05-2295
nct id: NCT04404231
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The patient and the investigator are blinded
measure: Change in depression score
time frame: Twice daily for the duration of the 4 week study
description: Using an App based approach, patients will enter their depression score
measure: Alteration in brain metabolism
time frame: Twice. One imaging study before treatment and one at the end of the 4 weeks of treatment
description: Functional MRI will be done to assess brain function and determine the effect of infrared light treatment on brain metabolics
arm group label: No infrared light therapy
arm group type: Sham Comparator
description: This arm does not receive any phototherapy
arm group label: 810 nm
arm group type: Active Comparator
description: Many clinical studies have used 810nm twice a week for 4 weeks. This is the standard.
arm group label: 945nm
arm group type: Experimental
description: This wavelength has been chosen as a comparison to 810, to see if it works better.
arm group label: random frequency
arm group type: Experimental
description: A wavelength between 650-1100nm which is picked at random
intervention type: Radiation
intervention name: Delivery of infrared light to the head
description: 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.
arm group label: 810 nm
arm group label: 945nm
arm group label: random frequency
intervention type: Other
intervention name: No Infrared treatment
description: This is sham treatment. No light is actually given.
arm group label: No infrared light therapy
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maurice-Andre Recanati, MD
phone: 19173316203
email: marecanati@gmail.com
facility: 
country: United States
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.
PMID: 31819453
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.
PMID: 30346890
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Maurice-Andre Recanati
investigator title: Assistant Professor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No