Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)

NCT00724490 | Completed

• 1 other identifier: Ocdbs-Psy-120304
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 resistant Obsessive Compulsive Disorder within two years.

Conditions

Obsessive Compulsive Disorder

Keywords

Deep Brain Stimulation; Obsessive Compulsive Disorder; Nucleus Accumbens

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale

  Baseline (preoperative), 1week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Secondary Outcomes (1)

• Beck Depression Inventory

  Baseline (preoperative), 1 week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Interventions

Deep Brain Stimulation PROCEDURE

Unilateral Deep Brain Stimulation in the right Nucleus Accumbens

Also known as: Model 3387 DBS Lead, Medtronic, Minneapolis, USA

Eligibility Criteria

• Age: 21 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 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
• pregnancy
• lactation period

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Department of Psychiatry, University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

Location

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

• Joachim Klosterkötter, MD

  Department of Psychiatry, Head of Department, University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: February 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: February 1, 2008
• Last Updated: July 29, 2008

Record last verified: 2008-07

Locations

DE (1)