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van CCT (UK)

van CCT (UK)

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

- candidate number2010
- NTR NumberNTR621
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR10-mrt-2006
- Secondary IDsN/A 
- Public TitleDeep brain stimulation (DBS) of the nucleus accumbens in treatment-refractory patients with obsessive-compulsive disorder (OCD).
- Scientific TitleDeep brain stimulation (DBS) of the nucleus accumbens in treatment-refractory patients with obsessive-compulsive disorder (OCD).
- hypothesisDBS in the nucleus accumbens can lead to long-term improvement of obsessive-compulsive symptoms and funtioning, without unacceptable side-effects.
- Healt Condition(s) or Problem(s) studiedObsessive-compulsive disorder (OCD)
- Inclusion criteria1. 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 <45;
5. Age 18 - 65 years;
6. Written informed consent;
7. Able to fully understand the consequences of the procedure (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 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 criteriaAny 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-mrt-2006
- planned closingdate1-jul-2007
- Target number of participants16
- InterventionsStereotactic implantation of bilateral DBS electrodes in the nucleus accumbens, placebo: no stimulation.
- Primary outcome1. Change on the Y-BOCS;
2. Number of responders, defined as a decrease on the Y-BOCS >35%.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- PublicationsN/A
- Brief summaryObjective of the study is to test the hypothesis that bilateral DBS in the nucleus accumbens of patients with severe treatment-refractory OCD can lead to long-term improvement of OCD symptoms and functioning, without unacceptable side-effects. The study design is a double-blind cross-over trial in which sixteen patients are to be included. Selected patients are reviewed by an independent approval-board. After electrode implantation an optimisation period is used to test stimulation parameter settings and check for side-effects of stimulation. In the ensuing cross-over period of six weeks without and six weeks with stimulation, the order being determined by randomization, patients are followed closely on an outpatient-basis. Thereafter the study continues with stimulation on in all patients.
Ethical review boards of both hospital have approved the study. An independent safety-committee is informed of all surgeries being performed and all events encountered in the study.
- Main changes (audit trail)
- RECORD10-mrt-2006 - 1-dec-2009

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