No registrations found.
ID
Source
Brief title
Health condition
Obsessive-compulsive disorder (OCD)
Sponsors and support
No personal funding of research personell.
Intervention
Outcome measures
Primary outcome
1. Change on the Y-BOCS;
2. Number of responders, defined as a decrease on the Y-BOCS >35%.
Secondary outcome
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.
Background summary
Objective 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.
Study objective
DBS in the nucleus accumbens can lead to long-term improvement of obsessive-compulsive symptoms and funtioning, without unacceptable side-effects.
Study design
N/A
Intervention
Stereotactic implantation of bilateral DBS electrodes in the nucleus accumbens, placebo: no stimulation.
P.O. Box 22660
P.R. Schuurman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
p.r.schuurman@amc.nl
P.O. Box 22660
P.R. Schuurman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
p.r.schuurman@amc.nl
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 <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 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL565 |
| NTR-old | NTR621 |
| Other | : N/A |
| ISRCTN | ISRCTN23255677 |