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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Deep Brain Stimulation

Stimulation is on.

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Placebo

Stimulation is off.

Group Type SHAM_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

Interventions

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Deep Brain Stimulation

Intervention Type DEVICE

Other Intervention Names

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Implanted device

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No