<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/NCT02253355</url>
  </required_header>
  <id_info>
    <org_study_id>PINS-006</org_study_id>
    <nct_id>NCT02253355</nct_id>
  </id_info>
  <brief_title>PINS Stimulator System for Patients With Treatment Resistant Depression</brief_title>
  <official_title>PINS Stimulator System for Patients With Treatment Resistant Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Pins Medical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Pins Medical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with&#xD;
      Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to&#xD;
      evaluate the influence of acupuncture on patients, which will be afford objective evidence&#xD;
      for the mechanism of Acupuncture on depression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the Hamilton Depression Rating Scale-17</measure>
    <time_frame>1, 3, 6 and 12 months of stimulation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of all adverse events</measure>
    <time_frame>1, 3, 6 and 12 months of stimulation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Treatment-Resistant Depression</condition>
  <arm_group>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stimulation is on</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Stimulation is off</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep Brain Stimulation</intervention_name>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>PINS Stimulator System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is aged ages 20-70 years&#xD;
&#xD;
          2. Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by&#xD;
             DSM-IV-TR criteria&#xD;
&#xD;
          3. First episode onset before age 45&#xD;
&#xD;
          4. Current episode &gt; 12 months duration&#xD;
&#xD;
          5. In the current episode: Documented resistance (i.e. persistence of the major&#xD;
             depressive episode) to a minimum of 4 adequate depression treatments from at least 3&#xD;
             different treatment categories (e.g. SSRI's)&#xD;
&#xD;
          6. SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium&#xD;
             augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score&#xD;
             of at least 3 according to the amended Antidepressant Treatment History Form (ATHF)&#xD;
             criteria&#xD;
&#xD;
          7. Hamilton Depression Rating Scale (HDRS) of &gt; 20 at 3 separate baseline visits, rated&#xD;
             by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve ≥&#xD;
             25%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with hearing impairment&#xD;
&#xD;
          2. Failures of important organs and in severe conditions&#xD;
&#xD;
          3. Be reluctant or disabled to receive neuropsychological assessments;&#xD;
&#xD;
          4. Participate in other clinical trial&#xD;
&#xD;
          5. Has a life expectancy of &lt; 1 year&#xD;
&#xD;
          6. The investigator and/or enrollment review committee, would preclude participation in&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Luming, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Tsinghua University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jia Fumin, PhD</last_name>
    <phone>+86 010-59361265</phone>
    <email>pins_medical@163.com</email>
  </overall_contact>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>October 13, 2016</last_update_submitted>
  <last_update_submitted_qc>October 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Treatment-Resistant</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/NCT02253355
org study id: PINS-006
nct id: NCT02253355
lead sponsor: 
collaborator: 
has dmc: Yes
Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with
      Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to
      evaluate the influence of acupuncture on patients, which will be afford objective evidence
      for the mechanism of Acupuncture on depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Changes in the Hamilton Depression Rating Scale-17
time frame: 1, 3, 6 and 12 months of stimulation
measure: The incidence of all adverse events
time frame: 1, 3, 6 and 12 months of stimulation
arm group label: Deep Brain Stimulation
arm group type: Experimental
description: Stimulation is on
arm group label: Placebo
arm group type: Sham Comparator
description: Stimulation is off
intervention type: Device
intervention name: Deep Brain Stimulation
arm group label: Deep Brain Stimulation
arm group label: Placebo
other name: PINS Stimulator System
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Li Luming, PhD
role: Study Chair
affiliation: Tsinghua University
last name: Jia Fumin, PhD
phone: +86 010-59361265
email: pins_medical@163.com
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Treatment-Resistant