Deep brain stimulation (DBS) of the nucleus accumbens in treatment-refractory patients with obsessive-compulsive disorder (OCD).
Completed
- Conditions
- Obsessive-compulsive disorder (OCD)
- Registration Number
- NL-OMON20428
- Lead Sponsor
- Implantation equipment is provided by Medtronic Europe, Tolochenaz, Switzerland.No personal funding of research personell.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
1. Primary diagnosis: OCD (300.3) according to DSM-IV criteria using the MINI Plus-interview as diagnostic instrument;
2. Illness duration > 5 years;
Exclusion Criteria
Any of the following: unstable physical condition, Parkinson's disease, dementia, epilepsy, schizophrenia or history of psychosis, alcohol or substance abuse during last 6 months, current tic disorder, antisocial personality disorder, body dismorphic disorder, pregnancy, use of psychiatric medication other than: stable use of one SSRI or clomipramine, one benzodiazepine, one atypical antipsychotic.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change on the Y-BOCS;<br /><br>2. Number of responders, defined as a decrease on the Y-BOCS >35%.
- Secondary Outcome Measures
Name Time Method 1. Hamilton Depression Rating Scale (HDRS-17);<br /><br>2. Hamilton Anxiety Scale (HAS);<br /><br>3. Symptom Checklist 90 (SCL-90);<br /><br>4. Quality of life enjoyment and satisfaction questionnaire;<br /><br>5. Sheehan Disability Scale (SDS);<br /><br>6. Clinical Global Impre3ssion (CGI);<br /><br>7. Y-BOCS checklist.