Status:
UNKNOWN
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Collaborating Sponsors:
Beijing Tiantan Hospital
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02253472
Start Date
December 1 2016
End Date
December 1 2018
Last Update
October 14 2016
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