<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/NCT02253472</url>
  </required_header>
  <id_info>
    <org_study_id>PINS-008</org_study_id>
    <nct_id>NCT02253472</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder</brief_title>
  <official_title>The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder</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>
      The purpose of this clinical study is To verify the long term effectiveness and safety of a&#xD;
      bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a&#xD;
      treatment option for patients with cognitive, behavioral, and functional disability of&#xD;
      Obsessive-Compulsive Disorder.&#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>Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hamilton anxiety scale (HAMD)</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Obsessive-Compulsive Disorder</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>Implanted device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Obsessive compulsive disorder (according to DSM IV-criteria) as the primary&#xD;
             psychiatric diagnosis.&#xD;
&#xD;
          2. Severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale.&#xD;
&#xD;
          3. Course of illness had to have been present for at least five years in a chronic or&#xD;
             progressive form despite any treatment trials (treatment resistance).&#xD;
&#xD;
          4. Treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI&#xD;
             and clomipramine in 5.Sufficient dosages for at least 10 weeks, an augmentation trial&#xD;
             with lithium, buspirone or a neuroleptic Lasting at least 10 weeks, and complete&#xD;
             cognitive-behavioral psychotherapy, including &quot;exposure and response Prevention&quot; of a&#xD;
             minimum of 20 sessions with a documented lack of efficiency.&#xD;
&#xD;
        6.The ability to give written and informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Co-morbid psychotic disorder according to DSM-IV criteria&#xD;
&#xD;
          2. Suicidal tendencies in the last 6 months&#xD;
&#xD;
          3. History of cerebral trauma&#xD;
&#xD;
          4. Clinically relevant internal or neurological disorder&#xD;
&#xD;
          5. Substance misuse or dependence in the last six months&#xD;
&#xD;
          6. Ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the&#xD;
             implantation of a DBS&#xD;
&#xD;
          7. Participate in other clinical trial&#xD;
&#xD;
          8. The investigator and/or enrollment review committee, would preclude participation in&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>010-59361265</phone>
    <email>pins_medical@163.com</email>
  </overall_contact>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 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>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</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/NCT02253472
org study id: PINS-008
nct id: NCT02253472
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this clinical study is To verify the long term effectiveness and safety of a
      bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a
      treatment option for patients with cognitive, behavioral, and functional disability of
      Obsessive-Compulsive Disorder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)
time frame: 12 month
measure: Hamilton anxiety scale (HAMD)
time frame: 12 month
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: Implanted device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Li Luming, PhD
role: Study Chair
affiliation: Tsinghua University
last name: Jia Fumin, PhD
phone: 010-59361265
email: pins_medical@163.com
responsible party type: Sponsor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder