Back to resultsThe 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
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
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
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
NCT ID
NCT02253472
First Posted
September 29, 2014
Last Updated
October 13, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
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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