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The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis.
  2. Severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale.
  3. Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance).
  4. Treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in 5.Sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic Lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response Prevention" of a minimum of 20 sessions with a documented lack of efficiency.

6.The ability to give written and informed consent.

Exclusion Criteria:

  1. Co-morbid psychotic disorder according to DSM-IV criteria
  2. Suicidal tendencies in the last 6 months
  3. History of cerebral trauma
  4. Clinically relevant internal or neurological disorder
  5. Substance misuse or dependence in the last six months
  6. Ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS
  7. Participate in other clinical trial
  8. The investigator and/or enrollment review committee, would preclude participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Deep Brain Stimulation

    Placebo

    Arm Description

    Stimulation is on.

    Stimulation is off.

    Outcomes

    Primary Outcome Measures

    Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)

    Secondary Outcome Measures

    Hamilton anxiety scale (HAMD)

    Full Information

    First Posted
    September 29, 2014
    Last Updated
    October 13, 2016
    Sponsor
    Beijing Pins Medical Co., Ltd
    Collaborators
    Beijing Tiantan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02253472
    Brief Title
    The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder
    Official Title
    The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Pins Medical Co., Ltd
    Collaborators
    Beijing Tiantan Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Deep Brain Stimulation
    Arm Type
    Experimental
    Arm Description
    Stimulation is on.
    Arm Title
    Placebo
    Arm Type
    Sham Comparator
    Arm Description
    Stimulation is off.
    Intervention Type
    Device
    Intervention Name(s)
    Deep Brain Stimulation
    Other Intervention Name(s)
    Implanted device
    Primary Outcome Measure Information:
    Title
    Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)
    Time Frame
    12 month
    Secondary Outcome Measure Information:
    Title
    Hamilton anxiety scale (HAMD)
    Time Frame
    12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis. Severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale. Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance). Treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in 5.Sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic Lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response Prevention" of a minimum of 20 sessions with a documented lack of efficiency. 6.The ability to give written and informed consent. Exclusion Criteria: Co-morbid psychotic disorder according to DSM-IV criteria Suicidal tendencies in the last 6 months History of cerebral trauma Clinically relevant internal or neurological disorder Substance misuse or dependence in the last six months Ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS Participate in other clinical trial The investigator and/or enrollment review committee, would preclude participation in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jia Fumin, PhD
    Phone
    010-59361265
    Email
    pins_medical@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li Luming, PhD
    Organizational Affiliation
    Tsinghua University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder

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