<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/NCT03010488</url>
  </required_header>
  <id_info>
    <org_study_id>7361</org_study_id>
    <secondary_id>7361</secondary_id>
    <nct_id>NCT03010488</nct_id>
  </id_info>
  <brief_title>Are Bright Lights and Regulated Sleep Effective Treatment for Depression?</brief_title>
  <official_title>Are Bright Lights and Regulated Sleep Effective Treatment for Depression.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous data suggest some depressed patients act as if their internal biological clock is&#xD;
      out of sync with the outside world and re-aligning their clock with the timing of sunlight&#xD;
      lessens their depressed mood and accompanying depressive symptoms. This &quot;chronotherapy&quot; may&#xD;
      produce remission during the first week of treatment while causing minimal problems. This&#xD;
      study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for&#xD;
      inducing sleep phase advance. Which chronotherapy condition a participant will receive will&#xD;
      be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to&#xD;
      determination of which protocol a patient will follow, each patient will declare their&#xD;
      desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific&#xD;
      times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned&#xD;
      sleep times will differ between groups using different strategies to shift the timing of&#xD;
      their sleep from their ideal sleep time as determined by their Morningness-Eveningness&#xD;
      Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily&#xD;
      by telephone for the first week following randomization, and then weekly for an additional&#xD;
      five weeks. Whenever possible, weekly visits will be in person, although telephone visits&#xD;
      will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an&#xD;
      Independent Evaluator blind to treatment assignment (as well as the nature of the treatment&#xD;
      and if it has occurred or not). After the six week post-randomization evaluation, all&#xD;
      participants will be offered six months of continued treatment and be rated monthly.&#xD;
      Treatment during this six month period may consist of Chronotherapy or conventional&#xD;
      antidepressants as the patient and doctor determine. Standard ratings of depression, over-all&#xD;
      illness and functioning will be obtained. Change in the symptom measures will determine&#xD;
      treatment efficacy. Analysis of saliva melatonin levels, sleep logs and activity monitor data&#xD;
      will measure the timing of the biological clock and whether it has been shifted by the&#xD;
      treatment. Measures of functioning will determine whether functioning improves coincident&#xD;
      with, independent of, or subsequent to mood improvement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will investigate the utility of regimented sleep and lights in depressed subjects.&#xD;
      Based on current timing of sleep, desired sleep time and responses to the&#xD;
      Morningness-Eveningness Questionnaire, each subject who remains significantly depressed at&#xD;
      their randomization (usually 2nd) visit, will be randomly assigned to one of two regimented&#xD;
      sleep and light use protocols. On the night beginning their assigned regimented protocol,&#xD;
      each subject will wear amber goggles for five hours and collect half hourly saliva samples&#xD;
      for four hours. Each morning they will sit in front of a light box wearing goggles. During&#xD;
      the first week following the start of the regimented protocol, they will complete self-report&#xD;
      forms and have a telephone interview to document their depressive symptoms. They will have&#xD;
      weekly in person interviews for six weeks and evaluations by an independent evaluator in&#xD;
      person or by telephone at randomization, 2 and 6 weeks. Prior to their Week 2 Visit, they&#xD;
      will wear the goggles for the four hours prior to their assigned bedtime and for the three&#xD;
      hours prior to their assigned bedtime, they will collect half hourly saliva samples. At their&#xD;
      Week 6 interview, they and their doctor will determine whether they have improved&#xD;
      sufficiently or not. Their doctor will discuss with them whether it makes sense for them to&#xD;
      continue the same regimented sleep/light schedule, make a change to it or switch to or add&#xD;
      additional treatment, such as antidepressant medication. They will then be followed with&#xD;
      study ratings monthly for six months, during which treatment is unrestricted; that is, the&#xD;
      doctor and patient can determine what the treatment during this time will be. Following the&#xD;
      six months follow-up, a referral will be made if appropriate.&#xD;
&#xD;
      All saliva samples will be analyzed for melatonin concentration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator)</measure>
    <time_frame>Week 6</time_frame>
    <description>Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items.&#xD;
sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression &gt;=23 = Very Severe Depression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant Sleep Efficiency</measure>
    <time_frame>Week 6</time_frame>
    <description>Sleep Efficiency (percentage of time spent sleeping during target sleep period) as measured by activity monitor and sleep logs.&#xD;
Sleep logs: Patients were instructed to record all sleep periods in the daily log by marking boxes representing 15-minute intervals. They were also requested to wear the Actigraph activity monitor at all times except for bathing, swimming, or any other activities requiring immersion of the wrist. In addition, patients were provided with schedules delineating their allowed sleep time each day.&#xD;
Patients chose their target sleep times (an eight-hour time they desired their sleep to occur) and completed the Morningness-Eveningness Questionnaire (MEQ) to estimate the timing of their circadian clocks, including ideal sleep and wake-up times.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Sleep Phase Rhythm Disturbance</condition>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>Rapid Sleep Shift</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing goggles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gradual Sleep Shift</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing goggles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Morning Light Therapy</intervention_name>
    <description>10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.</description>
    <arm_group_label>Gradual Sleep Shift</arm_group_label>
    <arm_group_label>Rapid Sleep Shift</arm_group_label>
    <other_name>Light Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Assigned Sleep Times</intervention_name>
    <description>Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.</description>
    <arm_group_label>Gradual Sleep Shift</arm_group_label>
    <arm_group_label>Rapid Sleep Shift</arm_group_label>
    <other_name>Sleep Phase Advance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Goggles</intervention_name>
    <description>Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
    <arm_group_label>Gradual Sleep Shift</arm_group_label>
    <arm_group_label>Rapid Sleep Shift</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently Depressed&#xD;
&#xD;
          -  In reasonably good physical health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bipolar Disorder (I, II, or unspecified)&#xD;
&#xD;
          -  History of psychosis&#xD;
&#xD;
          -  Unstable medical condition&#xD;
&#xD;
          -  Current (past 6 months) drug or alcohol use disorder&#xD;
&#xD;
          -  Need for hospitalization&#xD;
&#xD;
          -  Treating clinician determines not to include patient in this protocol&#xD;
&#xD;
          -  Currently taking medications approved for the treatment of depression&#xD;
&#xD;
          -  Un- or poorly controlled hypertension&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan W Stewart, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York State Psychiatric Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Depression Evaluation Service - New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>October 30, 2020</results_first_submitted>
  <results_first_submitted_qc>February 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 23, 2021</results_first_posted>
  <last_update_submitted>February 26, 2021</last_update_submitted>
  <last_update_submitted_qc>February 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>David J. Hellerstein</investigator_full_name>
    <investigator_title>Professor of Clinical Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Chronotherapy</keyword>
  <keyword>Light Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All non-identifiable data will be made available to qualified researchers on request to the study PI.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Information will be sent as soon as is practical and will be available as long as the PI is available.</ipd_time_frame>
    <ipd_access_criteria>Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03010488/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03010488/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03010488/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Rapid Sleep Shift</title>
          <description>Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
        </group>
        <group group_id="P2">
          <title>Gradual Sleep Shift</title>
          <description>Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Rapid Sleep Shift</title>
          <description>Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
        </group>
        <group group_id="B2">
          <title>Gradual Sleep Shift</title>
          <description>Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="44"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.8" spread="14.3"/>
                    <measurement group_id="B2" value="38.8" spread="16.4"/>
                    <measurement group_id="B3" value="38.3" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator)</title>
        <description>Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items.&#xD;
sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression &gt;=23 = Very Severe Depression</description>
        <time_frame>Week 6</time_frame>
        <population>Due to rater availability we weren't able to get independent evaluations on all participants. The numbers listed or the number we were able to get independent evaluations on.</population>
        <group_list>
          <group group_id="O1">
            <title>Rapid Sleep Shift</title>
            <description>Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
          </group>
          <group group_id="O2">
            <title>Gradual Sleep Shift</title>
            <description>Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
          </group>
        </group_list>
        <measure>
          <title>17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator)</title>
          <description>Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items.&#xD;
sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression &gt;=23 = Very Severe Depression</description>
          <population>Due to rater availability we weren't able to get independent evaluations on all participants. The numbers listed or the number we were able to get independent evaluations on.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.66" spread="6.09"/>
                    <measurement group_id="O2" value="10.46" spread="7.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Sleep Efficiency</title>
        <description>Sleep Efficiency (percentage of time spent sleeping during target sleep period) as measured by activity monitor and sleep logs.&#xD;
Sleep logs: Patients were instructed to record all sleep periods in the daily log by marking boxes representing 15-minute intervals. They were also requested to wear the Actigraph activity monitor at all times except for bathing, swimming, or any other activities requiring immersion of the wrist. In addition, patients were provided with schedules delineating their allowed sleep time each day.&#xD;
Patients chose their target sleep times (an eight-hour time they desired their sleep to occur) and completed the Morningness-Eveningness Questionnaire (MEQ) to estimate the timing of their circadian clocks, including ideal sleep and wake-up times.</description>
        <time_frame>Week 6</time_frame>
        <population>Due to rater availability we weren't able to get independent evaluations on all participants. The numbers listed or the number we were able to get independent evaluations on.</population>
        <group_list>
          <group group_id="O1">
            <title>Rapid Sleep Shift</title>
            <description>Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
          </group>
          <group group_id="O2">
            <title>Gradual Sleep Shift</title>
            <description>Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Sleep Efficiency</title>
          <description>Sleep Efficiency (percentage of time spent sleeping during target sleep period) as measured by activity monitor and sleep logs.&#xD;
Sleep logs: Patients were instructed to record all sleep periods in the daily log by marking boxes representing 15-minute intervals. They were also requested to wear the Actigraph activity monitor at all times except for bathing, swimming, or any other activities requiring immersion of the wrist. In addition, patients were provided with schedules delineating their allowed sleep time each day.&#xD;
Patients chose their target sleep times (an eight-hour time they desired their sleep to occur) and completed the Morningness-Eveningness Questionnaire (MEQ) to estimate the timing of their circadian clocks, including ideal sleep and wake-up times.</description>
          <population>Due to rater availability we weren't able to get independent evaluations on all participants. The numbers listed or the number we were able to get independent evaluations on.</population>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.43" spread="10.82"/>
                    <measurement group_id="O2" value="68.23" spread="28.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7.5 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Rapid Sleep Shift</title>
          <description>Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
        </group>
        <group group_id="E2">
          <title>Gradual Sleep Shift</title>
          <description>Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.&#xD;
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.&#xD;
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.&#xD;
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David Hellerstein</name_or_title>
      <organization>New York State Psychiatric Institute</organization>
      <phone>646-774-8069</phone>
      <email>david.hellerstein@nyspi.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03010488
org study id: 7361
secondary id: 7361
nct id: NCT03010488
lead sponsor: 
has dmc: No
Previous data suggest some depressed patients act as if their internal biological clock is
      out of sync with the outside world and re-aligning their clock with the timing of sunlight
      lessens their depressed mood and accompanying depressive symptoms. This "chronotherapy" may
      produce remission during the first week of treatment while causing minimal problems. This
      study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for
      inducing sleep phase advance. Which chronotherapy condition a participant will receive will
      be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to
      determination of which protocol a patient will follow, each patient will declare their
      desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific
      times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned
      sleep times will differ between groups using different strategies to shift the timing of
      their sleep from their ideal sleep time as determined by their Morningness-Eveningness
      Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily
      by telephone for the first week following randomization, and then weekly for an additional
      five weeks. Whenever possible, weekly visits will be in person, although telephone visits
      will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an
      Independent Evaluator blind to treatment assignment (as well as the nature of the treatment
      and if it has occurred or not). After the six week post-randomization evaluation, all
      participants will be offered six months of continued treatment and be rated monthly.
      Treatment during this six month period may consist of Chronotherapy or conventional
      antidepressants as the patient and doctor determine. Standard ratings of depression, over-all
      illness and functioning will be obtained. Change in the symptom measures will determine
      treatment efficacy. Analysis of saliva melatonin levels, sleep logs and activity monitor data
      will measure the timing of the biological clock and whether it has been shifted by the
      treatment. Measures of functioning will determine whether functioning improves coincident
      with, independent of, or subsequent to mood improvement.
This study will investigate the utility of regimented sleep and lights in depressed subjects.
      Based on current timing of sleep, desired sleep time and responses to the
      Morningness-Eveningness Questionnaire, each subject who remains significantly depressed at
      their randomization (usually 2nd) visit, will be randomly assigned to one of two regimented
      sleep and light use protocols. On the night beginning their assigned regimented protocol,
      each subject will wear amber goggles for five hours and collect half hourly saliva samples
      for four hours. Each morning they will sit in front of a light box wearing goggles. During
      the first week following the start of the regimented protocol, they will complete self-report
      forms and have a telephone interview to document their depressive symptoms. They will have
      weekly in person interviews for six weeks and evaluations by an independent evaluator in
      person or by telephone at randomization, 2 and 6 weeks. Prior to their Week 2 Visit, they
      will wear the goggles for the four hours prior to their assigned bedtime and for the three
      hours prior to their assigned bedtime, they will collect half hourly saliva samples. At their
      Week 6 interview, they and their doctor will determine whether they have improved
      sufficiently or not. Their doctor will discuss with them whether it makes sense for them to
      continue the same regimented sleep/light schedule, make a change to it or switch to or add
      additional treatment, such as antidepressant medication. They will then be followed with
      study ratings monthly for six months, during which treatment is unrestricted; that is, the
      doctor and patient can determine what the treatment during this time will be. Following the
      six months follow-up, a referral will be made if appropriate.

      All saliva samples will be analyzed for melatonin concentration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: 17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator)
time frame: Week 6
description: Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items.
sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression
measure: Participant Sleep Efficiency
time frame: Week 6
description: Sleep Efficiency (percentage of time spent sleeping during target sleep period) as measured by activity monitor and sleep logs.
Sleep logs: Patients were instructed to record all sleep periods in the daily log by marking boxes representing 15-minute intervals. They were also requested to wear the Actigraph activity monitor at all times except for bathing, swimming, or any other activities requiring immersion of the wrist. In addition, patients were provided with schedules delineating their allowed sleep time each day.
Patients chose their target sleep times (an eight-hour time they desired their sleep to occur) and completed the Morningness-Eveningness Questionnaire (MEQ) to estimate the timing of their circadian clocks, including ideal sleep and wake-up times.
arm group label: Rapid Sleep Shift
arm group type: Experimental
description: Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing goggles.
arm group label: Gradual Sleep Shift
arm group type: Active Comparator
description: Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing goggles.
intervention type: Behavioral
intervention name: Morning Light Therapy
description: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
arm group label: Gradual Sleep Shift
arm group label: Rapid Sleep Shift
other name: Light Therapy
intervention type: Behavioral
intervention name: Assigned Sleep Times
description: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
arm group label: Gradual Sleep Shift
arm group label: Rapid Sleep Shift
other name: Sleep Phase Advance
intervention type: Device
intervention name: Goggles
description: Subjects will wear goggles during saliva collection and Bright Light Therapy
arm group label: Gradual Sleep Shift
arm group label: Rapid Sleep Shift
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jonathan W Stewart, MD
role: Principal Investigator
affiliation: New York State Psychiatric Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: David J. Hellerstein
investigator title: Professor of Clinical Psychiatry
mesh term: Sleep Deprivation
sharing ipd: Yes
ipd description: All non-identifiable data will be made available to qualified researchers on request to the study PI.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Information will be sent as soon as is practical and will be available as long as the PI is available.
ipd access criteria: Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 