Obsessive-compulsive disorder (OCD)
Conditions
Interventions
Stereotactic implantation of bilateral DBS electrodes in the nucleus accumbens, placebo: no stimulation.
Sponsors
Implantation equipment is provided by Medtronic Europe, Tolochenaz, Switzerland.
No personal funding of research personell.
Eligibility
Inclusion criteria
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; 3. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total > 27, measured twice at least two weeks apart; 4. Disabling severity with substantial funtional impairment according to the DSM-IV criterion C and a Global Assessment of Function (GAF) score of 80); 8. Dutch speaking and able to answer all study questions; 9. Capable to make his or her own choice without coercion; 10. Treatment refractory is defined as no or insufficient response (still fulfilling the inclusion criteria) following: a. Two treatments with a SSRI at maximum dose for and least 12 weeks, and b. One treatment with clomipramine at the maximum dose for at least 12 weeks, with assessment of clomipramine/desmethylclomipramine plasma levels to control for sufficient bioavailability, and c. At least one augmentation trial with an atypical antipsychotic for 8 weeks in combination with a SSRI, and d. At least one (cognitive) behaviour therapy trial for 16 weeks in combination with an effective drug for the treatment of OCD.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change on the Y-BOCS; 2. Number of responders, defined as a decrease on the Y-BOCS >35%. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hamilton Depression Rating Scale (HDRS-17); 2. Hamilton Anxiety Scale (HAS); 3. Symptom Checklist 90 (SCL-90); 4. Quality of life enjoyment and satisfaction questionnaire; 5. Sheehan Disability Scale (SDS); 6. Clinical Global Impre3ssion (CGI); 7. Y-BOCS checklist. | — |
Contacts
Public ContactP.R. Schuurman
Academic Medical Center (AMC), department of Neurosurgery, P.O. Box 22660
Outcome results
None listed