Deep brain stimulation (DBS) of the nucleus accumbens in treatment-refractory patients with obsessive-compulsive disorder (OCD)

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 16

Inclusion Criteria

1. Primary diagnosis: OCD (300.3) according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria using the mini-international neuropsychiatric interview (MINI) plus interview as a 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 functional impairment according to the DSM-IV criterion C and a global assessment of function (GAF) score of <45
5. Age 18 - 65 years
6. Written informed consent
7. Able to fully understand the consequences of the procedure (intelligence quotient [IQ] >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 response or insufficient response (still fulfilling the inclusion criteria) following:
a. Two treatments with a selective serotonin reuptake inhibitor (SSRI) at a maximum dose for and least 12 weeks
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
c. At least one augmentation trial with an a typical antipsychotic for 8 weeks in combination with an SSRI
d. At least one (cognitive) behavioural therapy trial for 16 weeks in combination with an effective drug for the treatment of OCD

Exclusion Criteria

Any of the following unstable physical conditions: 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>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>2. Hamilton Anxiety Scale (HAS)<br>3. Symptom Checklist 90 (SCL-90)<br>4. Quality of life enjoyment and satisfaction questionnaire<br>5. Sheehan Disability Scale (SDS)<br>6. Clinical Global Impression (CGI)<br>7. Y-BOCS checklist

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