<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/NCT03282110</url>
  </required_header>
  <id_info>
    <org_study_id>ChinaACMS-3</org_study_id>
    <nct_id>NCT03282110</nct_id>
  </id_info>
  <brief_title>Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain</brief_title>
  <official_title>Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain: Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Experimental and clinical studies have indicated that acupuncture has a good effect for&#xD;
      depression and comorbid pain. The purpose of this research is to compare the effect of&#xD;
      comprehensive electro-acupuncture therapy and western medicine citalopram for for depressive&#xD;
      disorder with comorbid psychogenic pain. This research is a assessor blinded, randomized&#xD;
      controlled trials. 60 patients will be randomly divided into comprehensive&#xD;
      electro-acupuncture group and western medicine citalopram for 8 weeks treatment and the&#xD;
      therapeutic effect is done at the end of 1,2,4,6,8 week.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 30, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2018</primary_completion_date>
  <phase>Early Phase 1</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Montgomery-Asberg Depression Rating Scale Change</measure>
    <time_frame>Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks</time_frame>
    <description>Measure the severity of depressive episodes in patients with mood disorders, It contents ten items, and each item is scored 0-6.(0=no depression,6=depression as bad as can be), yielding a total between 0 and 60.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-McGill Pain Questionnaire</measure>
    <time_frame>Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks</time_frame>
    <description>Measure pain in 3 ways:1)pain rating indexes: pain intensity from feeling and emotional aspects, it includes fifteen items and each item is scored 0-3(0=no pain 3=severe) 2)present pain intensity, scored 0-5(0=no pain, 5=intense pain) 3)VAS: visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 Health Survey Questionnaire</measure>
    <time_frame>Baseline and 4 weeks, baseline and 8 weeks</time_frame>
    <description>Measure the self-reported living quality.It has eight sections:the physiological function, physiological function, the body pain, general health, energy, social function, emotional function and mental health.It consists of eight scaled scores, which are the weighted sums of the questions in their section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks</time_frame>
    <description>A self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating seven components that produce one global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Anxiety Rating Scale(HAMA)</measure>
    <time_frame>Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks</time_frame>
    <description>A psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.Each of the 14 items contains some symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Salivary cortisol levels</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>Serum cortisol levels positively correlated with the severity of depression, so that the saliva should be collected before and after treatment. Acquisition time of saliva: 7：30～8：30 am and 3:00-4:00 p.m</description>
  </other_outcome>
  <other_outcome>
    <measure>Physiological indexes</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>Including blood pressure, ECG, respiration, pulse check, blood routine, blood biochemistry, urine analysis to see if there is any change during treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse events that are related to treatment</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>Measure the incidence of adverse events of acupuncture such as fainting during acupuncture treatment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Depression; Psychoneurotic</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>ta-VNS &amp; Electro-acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device:ta-VNS(transcutaneous vagus nerve stimulation):2 times per day,5 consecutive days per week for two months&#xD;
Other:Electro-acupuncture:3 times per week, once every other day for two months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Citalopram</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>citalopram for oral administration; 10mg for the first 1-3 days, 20mg for the following 4-7 days；40mg for the left days within two months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ta-VNS</intervention_name>
    <description>The transcutaneous vagus nerve stimulation (taVNS) at auricular concha is a typical representative of TCM modernization. The taVNS regulates the autonomic nervous system, which shows a good therapeutic effect for the treatment of depression.</description>
    <arm_group_label>ta-VNS &amp; Electro-acupuncture</arm_group_label>
    <other_name>transcutaneous vagus nerve stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electro-acupuncture</intervention_name>
    <description>one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.</description>
    <arm_group_label>ta-VNS &amp; Electro-acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Citalopram</intervention_name>
    <description>Citalopram is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.It has U.S. Food and Drug Administration approval to treat major depression.</description>
    <arm_group_label>Citalopram</arm_group_label>
    <other_name>brand name：Cipramil, SFDA J20130028</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Conform with the diagnostic criteria of depression according to DIAGNOSTIC AND&#xD;
             STATISTICAL MANUAL OF MENTAL DISORDERS (DSM-5TM)&#xD;
&#xD;
          -  Age from 18 to 50 year-old&#xD;
&#xD;
          -  Patients with the first onset depression&#xD;
&#xD;
          -  Patients with mild-to-moderate depression scored 12-30 by Montgomery scale&#xD;
&#xD;
          -  Patients with one psychogenic pain at least, and the degree of VAS is 3 or more&#xD;
&#xD;
          -  Volunteer participants willing to cooperate and obeying the treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Patients with severe primary diseases and acute diseases of heart, brain, liver,&#xD;
             kidney and hematopoietic systems and infectious disease, malignant tumor&#xD;
&#xD;
          -  Patients who can't stop taking drugs according to the requirement in the treatment&#xD;
             period&#xD;
&#xD;
          -  Patients with a history of schizophrenia and other mental disorders&#xD;
&#xD;
          -  Patients with cognitive impairment or personality disorders&#xD;
&#xD;
          -  Patients have serious suicide idea or suicidal behavior&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peijing Rong, Dotor</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhangjing Zhang, Dotor</last_name>
    <role>Study Director</role>
    <affiliation>The School of Chinese Medicine, The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peijing Rong, Dotor</last_name>
    <phone>01064089301</phone>
    <email>drrongpj@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhangjin Zhang, Dotor</last_name>
    <phone>+86 18307556273</phone>
    <email>zhangzj@hku.hk</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>November 6, 2017</last_update_submitted>
  <last_update_submitted_qc>November 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Peijing Rong</investigator_full_name>
    <investigator_title>The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Citalopram</mesh_term>
  </intervention_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/NCT03282110
org study id: ChinaACMS-3
nct id: NCT03282110
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Experimental and clinical studies have indicated that acupuncture has a good effect for
      depression and comorbid pain. The purpose of this research is to compare the effect of
      comprehensive electro-acupuncture therapy and western medicine citalopram for for depressive
      disorder with comorbid psychogenic pain. This research is a assessor blinded, randomized
      controlled trials. 60 patients will be randomly divided into comprehensive
      electro-acupuncture group and western medicine citalopram for 8 weeks treatment and the
      therapeutic effect is done at the end of 1,2,4,6,8 week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Montgomery-Asberg Depression Rating Scale Change
time frame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
description: Measure the severity of depressive episodes in patients with mood disorders, It contents ten items, and each item is scored 0-6.(0=no depression,6=depression as bad as can be), yielding a total between 0 and 60.
measure: SF-McGill Pain Questionnaire
time frame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
description: Measure pain in 3 ways:1)pain rating indexes: pain intensity from feeling and emotional aspects, it includes fifteen items and each item is scored 0-3(0=no pain 3=severe) 2)present pain intensity, scored 0-5(0=no pain, 5=intense pain) 3)VAS: visual analog scale
measure: SF-36 Health Survey Questionnaire
time frame: Baseline and 4 weeks, baseline and 8 weeks
description: Measure the self-reported living quality.It has eight sections:the physiological function, physiological function, the body pain, general health, energy, social function, emotional function and mental health.It consists of eight scaled scores, which are the weighted sums of the questions in their section.
measure: Pittsburgh Sleep Quality Index
time frame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
description: A self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating seven components that produce one global score
measure: Hamilton Anxiety Rating Scale(HAMA)
time frame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
description: A psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.Each of the 14 items contains some symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe.
measure: Salivary cortisol levels
time frame: baseline and 8 weeks
description: Serum cortisol levels positively correlated with the severity of depression, so that the saliva should be collected before and after treatment. Acquisition time of saliva: 7：30～8：30 am and 3:00-4:00 p.m
measure: Physiological indexes
time frame: baseline and 8 weeks
description: Including blood pressure, ECG, respiration, pulse check, blood routine, blood biochemistry, urine analysis to see if there is any change during treatment
measure: Adverse events that are related to treatment
time frame: baseline and 8 weeks
description: Measure the incidence of adverse events of acupuncture such as fainting during acupuncture treatment.
arm group label: ta-VNS & Electro-acupuncture
arm group type: Experimental
description: Device:ta-VNS(transcutaneous vagus nerve stimulation):2 times per day,5 consecutive days per week for two months
Other:Electro-acupuncture:3 times per week, once every other day for two months
arm group label: Citalopram
arm group type: Active Comparator
description: citalopram for oral administration; 10mg for the first 1-3 days, 20mg for the following 4-7 days；40mg for the left days within two months
intervention type: Device
intervention name: ta-VNS
description: The transcutaneous vagus nerve stimulation (taVNS) at auricular concha is a typical representative of TCM modernization. The taVNS regulates the autonomic nervous system, which shows a good therapeutic effect for the treatment of depression.
arm group label: ta-VNS & Electro-acupuncture
other name: transcutaneous vagus nerve stimulation
intervention type: Other
intervention name: Electro-acupuncture
description: one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.
arm group label: ta-VNS & Electro-acupuncture
intervention type: Drug
intervention name: Citalopram
description: Citalopram is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.It has U.S. Food and Drug Administration approval to treat major depression.
arm group label: Citalopram
other name: brand name：Cipramil, SFDA J20130028
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Peijing Rong, Dotor
role: Study Director
affiliation: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
last name: Zhangjing Zhang, Dotor
role: Study Director
affiliation: The School of Chinese Medicine, The University of Hong Kong
last name: Peijing Rong, Dotor
phone: 01064089301
email: drrongpj@163.com
last name: Zhangjin Zhang, Dotor
phone: +86 18307556273
email: zhangzj@hku.hk
responsible party type: Principal Investigator
investigator affiliation: China Academy of Chinese Medical Sciences
investigator full name: Peijing Rong
investigator title: The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
mesh term: Depressive Disorder
mesh term: Citalopram
sharing ipd: Undecided