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

Early Phase 1

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT02253472
• Lead Sponsor: Beijing Pins Medical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Deep Brain Stimulation	Stimulation is off.
Deep Brain Stimulation	Deep Brain Stimulation	Stimulation is on.

Primary Outcome Measures

Name	Time	Method
Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)	12 month

Secondary Outcome Measures

Name	Time	Method
Hamilton anxiety scale (HAMD)	12 month