<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/NCT03300778</url>
  </required_header>
  <id_info>
    <org_study_id>Guangzhou Brain Hospital</org_study_id>
    <nct_id>NCT03300778</nct_id>
  </id_info>
  <brief_title>A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes</brief_title>
  <official_title>A Randomised Controlled Trial of Aerobic Exercise for Adolescents With Subthreshold Depressive and/or Hypomanic Syndrome and for Non-clinical Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Psychiatric Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 effects of aerobic exercise on mental states, cognition, and&#xD;
      long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and&#xD;
      in non-clinical school children&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subthreshold depressive and hypomanic symptoms are common in adolescents, increasing the risk&#xD;
      of developping into depression or bipolar disorder. Preliminary evidence shows that aerobic&#xD;
      exercise might have positive effects in enhancing cognition and improving clinical symptoms&#xD;
      in non-clinical and preclinical population and patients with mood disorders. This randomized&#xD;
      controlled trial will investigate short-term (3 months) effects of aerobic exercise on&#xD;
      cognition and clinical symptoms as well as the long-term (18 months) effects on the clinical&#xD;
      outcomes of high-risk states.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">January 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 5, 2018</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in depressive symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in neurocognitive function</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in anxious symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>anxious symptoms measured by Symptom Checklist 90 (SCL-90)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in brain connectivity</measure>
    <time_frame>12 weeks</time_frame>
    <description>using fMRI to measure brain connectivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with subthreshold mood symptoms</measure>
    <time_frame>18 months</time_frame>
    <description>number of participants who meet the subthreshold syndromes for depression and/or hypomania</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hypomanic symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>changes in hypomanic symptoms measured by Hypomania Check List-15(HCL-15)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">224</enrollment>
  <condition>Depressive Symptoms</condition>
  <condition>Hypomania Nos Single Episode or Unspecified</condition>
  <arm_group>
    <arm_group_label>aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Running at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo controlled group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>aerobic exercise</intervention_name>
    <description>Running at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months</description>
    <arm_group_label>aerobic exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo controlled group</intervention_name>
    <description>6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment.</description>
    <arm_group_label>Placebo controlled group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 2 or more DSM-IV defined depressive symptoms, with one as core symptoms ( lost&#xD;
             interest or pleasure in activity or depressed mood), lasting for 1 week.&#xD;
&#xD;
          2. 2 or more DSM-IV defined manic symptoms, last for 4 days, but falling short of the&#xD;
             criteria for hypomania; or meeting DSM-5 defined symptoms criteria for hypomania,&#xD;
             lasting 2-3 days.&#xD;
&#xD;
          3. non-clinical subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DSM-IV defined major depressive disorder&#xD;
&#xD;
          -  DSM-IV defined hypo/mania&#xD;
&#xD;
          -  History of or current other Axis I Disorders&#xD;
&#xD;
          -  Diagnosed neurological or musculoskeletal disorder/injury,&#xD;
&#xD;
          -  Uncontrolled cardiovascular or metabolic diseases that are not suitable for running&#xD;
&#xD;
          -  Diagnosed hypertension&#xD;
&#xD;
          -  Other diagnosed serious medical conditions that are not suitable for cycling&#xD;
&#xD;
          -  Severe suicidal ideation&#xD;
&#xD;
          -  Mental retardation&#xD;
&#xD;
          -  Currently participating in a exercise program or activity, defined as 30 minutes of&#xD;
             vigorous physical activity 4-5 times per week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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_official>
    <last_name>Guiyun Xu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Guangzhou Psychiatric Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangzhou Brain Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510370</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>August 22, 2018</last_update_submitted>
  <last_update_submitted_qc>August 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2018</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>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>neurocognition</keyword>
  <keyword>high-risk</keyword>
  <keyword>prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mania</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03300778
org study id: Guangzhou Brain Hospital
nct id: NCT03300778
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will investigate the effects of aerobic exercise on mental states, cognition, and
      long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and
      in non-clinical school children
Subthreshold depressive and hypomanic symptoms are common in adolescents, increasing the risk
      of developping into depression or bipolar disorder. Preliminary evidence shows that aerobic
      exercise might have positive effects in enhancing cognition and improving clinical symptoms
      in non-clinical and preclinical population and patients with mood disorders. This randomized
      controlled trial will investigate short-term (3 months) effects of aerobic exercise on
      cognition and clinical symptoms as well as the long-term (18 months) effects on the clinical
      outcomes of high-risk states.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes in depressive symptoms
time frame: 12 weeks
description: Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9)
measure: Changes in neurocognitive function
time frame: 12 weeks
description: Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
measure: changes in anxious symptoms
time frame: 12 weeks
description: anxious symptoms measured by Symptom Checklist 90 (SCL-90)
measure: Changes in brain connectivity
time frame: 12 weeks
description: using fMRI to measure brain connectivity
measure: Number of participants with subthreshold mood symptoms
time frame: 18 months
description: number of participants who meet the subthreshold syndromes for depression and/or hypomania
measure: Changes in hypomanic symptoms
time frame: 12 weeks
description: changes in hypomanic symptoms measured by Hypomania Check List-15(HCL-15)
arm group label: aerobic exercise
arm group type: Experimental
description: Running at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months
arm group label: Placebo controlled group
arm group type: Placebo Comparator
description: 6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment.
intervention type: Behavioral
intervention name: aerobic exercise
description: Running at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months
arm group label: aerobic exercise
intervention type: Behavioral
intervention name: Placebo controlled group
description: 6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment.
arm group label: Placebo controlled group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: kangguang Lin, MD; PhD
role: Principal Investigator
affiliation: Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
last name: Guiyun Xu, MD
role: Study Director
affiliation: Guangzhou Psychiatric Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Psychiatric Hospital
investigator full name: Kangguang Lin
investigator title: MD, PhD
mesh term: Mania
mesh term: Depression
sharing ipd: Undecided