<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/NCT04447430</url>
  </required_header>
  <id_info>
    <org_study_id>GuangzhouPHBLT</org_study_id>
    <nct_id>NCT04447430</nct_id>
  </id_info>
  <brief_title>Light Therapy to Improve Symptoms in Pregnant Women With Major Depressive Disorder</brief_title>
  <acronym>GZPHBLT</acronym>
  <official_title>Bright Light Therapy in Pregnant Women With Major Depressive Disorder: a Randomized, Double-blind, Placebo-Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Psychiatric Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Third Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou Psychiatric Hospital</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>
      This study will investigate the effectivenss of bright light therapy(10000 lux white)on&#xD;
      pregnant women with major depression disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression during pregnancy is a common and high impact disease.Children who are exposed to&#xD;
      maternal depression during pregnancy have a higher risk of adverse birth outcomes, such as&#xD;
      low birth weight, and more often show cognitive, emotional and behavioral problems.Therefore,&#xD;
      early detection and prompt treatment of depression during pregnancy can benefit both mother&#xD;
      and child.However, the window of opportunity in pregnancy is small and from the perspective&#xD;
      of the child postponement is in fact non-treatment. Psychotherapy might take a long time to&#xD;
      be effective and do not work for all people. Further, the safety of pharmacological treatment&#xD;
      for pregnant women with depression is still a big concern .Psychiatric medication use for&#xD;
      depression in pregnancy may also pose a risk of fetal growth retardation and preterm&#xD;
      delivery, as well as withdrawal symptoms in the new born. Therefore, investigating&#xD;
      non-pharmacological approaches to treating depression during pregnancy is urgent and&#xD;
      relevant, for both mother and child. Preliminary evidence shows that bright light therapy&#xD;
      (BLT) is an effective treatment for pregnant women with depression based on several&#xD;
      theoretical and clinical considerations, with effect size around 0.45 and without adverse&#xD;
      effects to the new born. In this study we aim to investigate the effectiveness of BLT on&#xD;
      pregnant women with major depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in depressive symptoms from baseline</measure>
    <time_frame>Week2;Week6</time_frame>
    <description>Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in anxious symptoms from baseline</measure>
    <time_frame>week 2; week 6</time_frame>
    <description>anxious symptoms will be measured by the Hamilton Anxiety Scale(HAMA)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>bright light group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treat patients with bright light (10000 lux)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dim red light group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>treat patients with dim red light (100 lux)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>bright light</intervention_name>
    <description>treat patients with bright light, 30 min per day, 7 times per week, over 6 weeks</description>
    <arm_group_label>bright light group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>dim red light</intervention_name>
    <description>treat patients with dim red light, 30 min per day, 7 times per week, over 6 weeks</description>
    <arm_group_label>dim red light group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women; 18~45 years of age; medically healthy, with normal ocular function; 13~28 weeks&#xD;
        pregnancy; DSM-V diagnosis of major depressive disorder HAMD score ≥18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        DSM-V defined bipolar disorder、schizophrenia、schizoaffective disorder,anxiety disorders;&#xD;
        substance Use Disorders; substance use within the last 6 months; suicidal ideation,&#xD;
        suicidal attempt, suicide behavior, and attempted suicide; being treated by the light&#xD;
        therapy; with antidepressant in recent 2 months; Multiple pregnancy; Any obstetrical care&#xD;
        or medications for physical disorders that might confound treatment results; current use of&#xD;
        β-adrenergic blockers, melatonin, or St. John's wort; thyroid function test results&#xD;
        inconsistent with normal pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kangguang Lin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou Brain Hospital(Guangzhou Psychiatric Hospital)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kangguang Lin, MD,PhD</last_name>
    <phone>13560360144</phone>
    <phone_ext>18028619981</phone_ext>
    <email>klin@connect.hku.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tao Liu, MD</last_name>
    <phone>15017554527</phone>
    <email>liutaolp@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangzhou Brain Hospital (Guangzhou Huiai Hospital)</name>
      <address>
        <city>Guanzhou</city>
        <state>Guangdong</state>
        <zip>510370</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kangguang Lin, MD，PhD</last_name>
      <phone>13560360144</phone>
      <email>klin@connect.hku.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Psychiatric Hospital</investigator_affiliation>
    <investigator_full_name>Kangguang Lin</investigator_full_name>
    <investigator_title>Department of Affective Disorder</investigator_title>
  </responsible_party>
  <keyword>Light therapy; Major Depressive Disorder; Pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT04447430
org study id: GuangzhouPHBLT
nct id: NCT04447430
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will investigate the effectivenss of bright light therapy(10000 lux white)on
      pregnant women with major depression disorder.
Depression during pregnancy is a common and high impact disease.Children who are exposed to
      maternal depression during pregnancy have a higher risk of adverse birth outcomes, such as
      low birth weight, and more often show cognitive, emotional and behavioral problems.Therefore,
      early detection and prompt treatment of depression during pregnancy can benefit both mother
      and child.However, the window of opportunity in pregnancy is small and from the perspective
      of the child postponement is in fact non-treatment. Psychotherapy might take a long time to
      be effective and do not work for all people. Further, the safety of pharmacological treatment
      for pregnant women with depression is still a big concern .Psychiatric medication use for
      depression in pregnancy may also pose a risk of fetal growth retardation and preterm
      delivery, as well as withdrawal symptoms in the new born. Therefore, investigating
      non-pharmacological approaches to treating depression during pregnancy is urgent and
      relevant, for both mother and child. Preliminary evidence shows that bright light therapy
      (BLT) is an effective treatment for pregnant women with depression based on several
      theoretical and clinical considerations, with effect size around 0.45 and without adverse
      effects to the new born. In this study we aim to investigate the effectiveness of BLT on
      pregnant women with major depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in depressive symptoms from baseline
time frame: Week2;Week6
description: Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)
measure: Changes in anxious symptoms from baseline
time frame: week 2; week 6
description: anxious symptoms will be measured by the Hamilton Anxiety Scale(HAMA)
arm group label: bright light group
arm group type: Experimental
description: treat patients with bright light (10000 lux)
arm group label: dim red light group
arm group type: Placebo Comparator
description: treat patients with dim red light (100 lux)
intervention type: Device
intervention name: bright light
description: treat patients with bright light, 30 min per day, 7 times per week, over 6 weeks
arm group label: bright light group
intervention type: Device
intervention name: dim red light
description: treat patients with dim red light, 30 min per day, 7 times per week, over 6 weeks
arm group label: dim red light group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Kangguang Lin, MD,PhD
role: Principal Investigator
affiliation: Guangzhou Brain Hospital(Guangzhou Psychiatric Hospital)
last name: Kangguang Lin, MD,PhD
phone: 13560360144
phone ext: 18028619981
email: klin@connect.hku.hk
last name: Tao Liu, MD
phone: 15017554527
email: liutaolp@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Psychiatric Hospital
investigator full name: Kangguang Lin
investigator title: Department of Affective Disorder
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
sharing ipd: No