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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02253472
• Other study ID #: PINS-008
• Status: Not yet recruiting
• Phase: Phase 0
• First received: September 29, 2014
• Last updated: October 13, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Jia Fumin, PhD
• Phone: 010-59361265
• Email: pins_medical[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Obsessive-Compulsive Disorder

Intervention

Device:
• Deep Brain Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)		12 month	Yes
Secondary	Hamilton anxiety scale (HAMD)		12 month	Yes