Deep brain stimulation (DBS) of the nucleus accumbens in treatment-refractory patients with obsessive-compulsive disorder (OCD)
| ISRCTN | ISRCTN23255677 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23255677 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funder | Academic Medical Center (AMC) |
- Submission date
- 07/06/2006
- Registration date
- 07/06/2006
- Last edited
- 30/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr P.R. Schuurman
Scientific
Scientific
Academic Medical Center (AMC)
Department of Neurosurgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5669111 |
|---|---|
| p.r.schuurman@amc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized, placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | DBS in the nucleus accumbens can lead to long-term improvement of obsessive-compulsive symptoms and functioning, without unacceptable side-effects. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Obsessive-compulsive disorder (OCD) |
| Intervention | Stereotactic implantation of bilateral DBS electrodes in the nucleus accumbens. Placebo: no stimulation. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Change on the Y-BOCS |
| Key secondary outcome measure(s) |
1. Hamilton Depression Rating Scale (HDRS-17) |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 16 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 27/03/2006 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | Yes | No | |
| Results article | results | 01/02/2014 | Yes | No |
