Status:
COMPLETED
Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)
Lead Sponsor:
University of Cologne
Conditions:
Obsessive Compulsive Disorder
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The purpose of the study was to evaluate whether a unilateral Deep Brain Stimulation of the right Nucleus Accumbens could lead to a more than 35% reduction of symptoms in patients with a treatment res...
Detailed Description
From the late ninety's on, a few work groups published the case series of patients with treatment resistant OCD undergoing deep brain stimulation (DBS). This stereotactical method involves surgically ...
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 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
- pregnancy
- lactation period
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00724490
Start Date
February 1 2004
End Date
February 1 2008
Last Update
July 29 2008
Active Locations (1)
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1
Department of Psychiatry, University of Cologne
Cologne, North Rhine-Westphalia, Germany, 50924