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

NCT02253472 | Unknown Early Phase 1 DMC

• 1 other identifier: PINS-008
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

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

  12 month

Secondary Outcomes (1)

• Hamilton anxiety scale (HAMD)

  12 month

Study Arms (2)

Deep Brain Stimulation

EXPERIMENTAL

Stimulation is on.

Device: Deep Brain Stimulation

Placebo

SHAM COMPARATOR

Stimulation is off.

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Also known as: Implanted device

Deep Brain Stimulation; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The ability to give written and informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead
• Beijing Tiantan Hospital: collaborator

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Li Luming, PhD

  Tsinghua University

  STUDY CHAIR

Central Study Contacts

Jia Fumin, PhD

CONTACT

010-59361265; pins_medical@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-08