<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/NCT04425278</url>
  </required_header>
  <id_info>
    <org_study_id>Yu</org_study_id>
    <nct_id>NCT04425278</nct_id>
  </id_info>
  <brief_title>tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder</brief_title>
  <official_title>Study of tDCS Intervention on Motivational Anhedonia of Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Anhui Medical 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>
      Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients underwent a medical evaluation that included physical examination and routine&#xD;
      laboratory studies before and after transcranial direct current stimulation (tDCS) treatment.&#xD;
      Patients were randomly allocated to real group , sham group or control group. A threshold of&#xD;
      3 points on the Hamilton Depression scale has been specified by the National Institute for&#xD;
      Health and Care Excellence to determine a clinically meaningful difference between active&#xD;
      pharmacotherapy and placebo. We plan to enroll minimum total sample size of 37 participants&#xD;
      in real, sham or control group respectively according to the Power and Sample Size program.&#xD;
      The decision to enroll a patient was always made prior to randomization. The tDCS&#xD;
      administrators had access to the randomization list. They had minimal contact with the&#xD;
      patients, and no role in assessing depression. Each patient would be treated for continuous&#xD;
      14 days by tDCS in real and sham group. The control group was evaluated by clinical symptom&#xD;
      scale, behavioral evaluation before and after 14 days.&#xD;
&#xD;
      Before the tDCS treatment, depression symptom of each participant was assessed by the&#xD;
      Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity&#xD;
      was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation&#xD;
      Scale, Dimensional Anhedonia Rating Scale, the Motivation and Pleasure Scale.The neuroimaging&#xD;
      data was collected using event-related potentials during monetary incentive delay task. After&#xD;
      the last treatment, the same scales and neuroimaging scan were used again to assess the&#xD;
      treatment effect of the tDCS and the underlying brain mechanism. Each participant was&#xD;
      interviewed in detail about the adverse event of the tDCS intervention during the past 14&#xD;
      days.Every participant should take part in the study in voluntary and sign an informed&#xD;
      consent form before the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Hamilton Depression Scale</measure>
    <time_frame>baseline;14 day post-treatment</time_frame>
    <description>The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Motivation and Pleasure Scale</measure>
    <time_frame>baseline;14 day post-treatment</time_frame>
    <description>The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in behavioral results of Monetary Incentive Delay task</measure>
    <time_frame>baseline; 14 day post-treatment change from baseline after the treatment.</time_frame>
    <description>The motivational anhedonia assessed by accuracy and response time in Monetary Incentive Delay task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in event-related brain potentials during the monetary incentive delay task</measure>
    <time_frame>baseline; 14 day post-treatment</time_frame>
    <description>The amplitudes of brain potentials of contingent negative variation and P3 assessed by event-related brain potentials methods change from baseline after the treatment.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Transcranial Direct Current Stimulation</condition>
  <condition>Major Depressive Disorder</condition>
  <condition>Event-Related Potentials</condition>
  <arm_group>
    <arm_group_label>Real Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Real Stimulation of tDCS lasted 20 mins.Behavior and ERPs dataset should be acquired before the first tDCS session and after the last tDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The Sham Stimulation of tDCS lasted 20 minutes with no current. In particular, the current went up for the first 30 seconds and went down for the last 30 seconds.Behavior and ERPs dataset should be acquired before the first tDCS session and after the last tDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Behavior and ERPs dataset should be acquired before and after 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation with real current</intervention_name>
    <description>transcranial direct current stimulation with real current is a noninvasive technique to activate and modify the activity of the neurons</description>
    <arm_group_label>Real Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation with sham current</intervention_name>
    <description>transcranial direct current stimulation with sham current is a placebo</description>
    <arm_group_label>Sham Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meet criteria of depression assessed by at least two psychiatrists according to the&#xD;
             five version of Diagnostic and Statistical Manual of Mental Disorders.&#xD;
&#xD;
          2. The score of Hamilton Depression Rating Scale-17 was larger than 18.&#xD;
&#xD;
          3. Patients were taking antidepressants--Selective Serotonin Reuptake Inhibitor(SSRIs)&#xD;
             alone.&#xD;
&#xD;
          4. Age was between 18 to 60 year old.&#xD;
&#xD;
          5. The education duration was at least 6 years.&#xD;
&#xD;
          6. The vision or corrected vision was normal.&#xD;
&#xD;
          7. Right handedness.&#xD;
&#xD;
          8. No treatment of rTMS, transcranial direct current stimulation or electroconvulsive&#xD;
             therapy before.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of significant head trauma or neurological disorders.&#xD;
&#xD;
          2. Alcohol or drug abuse.&#xD;
&#xD;
          3. Focal brain lesions.&#xD;
&#xD;
          4. History of seizure.&#xD;
&#xD;
          5. First degree relative with epilepsy, significant neurological illness or head trauma,&#xD;
             endocrine disease.&#xD;
&#xD;
          6. Significant unstable medical condition.&#xD;
&#xD;
          7. Recent aggression or other forms of behavioral dyscontrol.&#xD;
&#xD;
          8. Left-handedness.&#xD;
&#xD;
          9. Pregnancy.&#xD;
&#xD;
         10. Current alcohol or drug abuse&#xD;
&#xD;
         11. Inability to provide informed consent.&#xD;
&#xD;
         12. Patients with contraindications or factors affecting imaging quality, such as&#xD;
             pacemakers, cochlear implants, or hearts Cerebrovascular metal stent, and metal&#xD;
             denture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kai Wang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Anhui Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fengqiong Yu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Anhui Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fengqiong Yu, MD</last_name>
    <phone>0086055115955155423</phone>
    <email>yufengqin1@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fengqiong Yu</last_name>
      <email>yufengqin1@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Anhui Medical University</investigator_affiliation>
    <investigator_full_name>Fengqiong Yu</investigator_full_name>
    <investigator_title>A/Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anhedonia</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <!-- 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/NCT04425278
org study id: Yu
nct id: NCT04425278
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder
All patients underwent a medical evaluation that included physical examination and routine
      laboratory studies before and after transcranial direct current stimulation (tDCS) treatment.
      Patients were randomly allocated to real group , sham group or control group. A threshold of
      3 points on the Hamilton Depression scale has been specified by the National Institute for
      Health and Care Excellence to determine a clinically meaningful difference between active
      pharmacotherapy and placebo. We plan to enroll minimum total sample size of 37 participants
      in real, sham or control group respectively according to the Power and Sample Size program.
      The decision to enroll a patient was always made prior to randomization. The tDCS
      administrators had access to the randomization list. They had minimal contact with the
      patients, and no role in assessing depression. Each patient would be treated for continuous
      14 days by tDCS in real and sham group. The control group was evaluated by clinical symptom
      scale, behavioral evaluation before and after 14 days.

      Before the tDCS treatment, depression symptom of each participant was assessed by the
      Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity
      was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation
      Scale, Dimensional Anhedonia Rating Scale, the Motivation and Pleasure Scale.The neuroimaging
      data was collected using event-related potentials during monetary incentive delay task. After
      the last treatment, the same scales and neuroimaging scan were used again to assess the
      treatment effect of the tDCS and the underlying brain mechanism. Each participant was
      interviewed in detail about the adverse event of the tDCS intervention during the past 14
      days.Every participant should take part in the study in voluntary and sign an informed
      consent form before the study.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from baseline in Hamilton Depression Scale
time frame: baseline;14 day post-treatment
description: The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment.
measure: Change from baseline in Motivation and Pleasure Scale
time frame: baseline;14 day post-treatment
description: The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.
measure: The change from baseline in behavioral results of Monetary Incentive Delay task
time frame: baseline; 14 day post-treatment change from baseline after the treatment.
description: The motivational anhedonia assessed by accuracy and response time in Monetary Incentive Delay task
measure: The change from baseline in event-related brain potentials during the monetary incentive delay task
time frame: baseline; 14 day post-treatment
description: The amplitudes of brain potentials of contingent negative variation and P3 assessed by event-related brain potentials methods change from baseline after the treatment.
arm group label: Real Stimulation
arm group type: Active Comparator
description: The Real Stimulation of tDCS lasted 20 mins.Behavior and ERPs dataset should be acquired before the first tDCS session and after the last tDCS session.
arm group label: Sham Stimulation
arm group type: Sham Comparator
description: The Sham Stimulation of tDCS lasted 20 minutes with no current. In particular, the current went up for the first 30 seconds and went down for the last 30 seconds.Behavior and ERPs dataset should be acquired before the first tDCS session and after the last tDCS session.
arm group label: Control
arm group type: No Intervention
description: Behavior and ERPs dataset should be acquired before and after 14 days.
intervention type: Device
intervention name: transcranial direct current stimulation with real current
description: transcranial direct current stimulation with real current is a noninvasive technique to activate and modify the activity of the neurons
arm group label: Real Stimulation
intervention type: Device
intervention name: transcranial direct current stimulation with sham current
description: transcranial direct current stimulation with sham current is a placebo
arm group label: Sham Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Kai Wang, MD
role: Study Chair
affiliation: Anhui Medical University
last name: Fengqiong Yu, MD
role: Study Director
affiliation: Anhui Medical University
last name: Fengqiong Yu, MD
phone: 0086055115955155423
email: yufengqin1@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Anhui Medical University
investigator full name: Fengqiong Yu
investigator title: A/Prof.
mesh term: Anhedonia
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major