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ISRCTN
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ISRCTN23255677
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DOI
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10.1186/ISRCTN23255677
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Deep brain stimulation (DBS) of the nucleus accumbens in treatment-refractory patients with obsessive-compulsive disorder (OCD)
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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DBS in the nucleus accumbens can lead to long-term improvement of obsessive-compulsive symptoms and functioning, without unacceptable side-effects.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomized, placebo-controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Obsessive-compulsive disorder (OCD)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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.
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Anticipated start date
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27/03/2006
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Anticipated end date
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01/07/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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16
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Interventions
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Stereotactic implantation of bilateral DBS electrodes in the nucleus accumbens.
Placebo: no stimulation.
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Primary outcome measure(s)
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1. Change on the Y-BOCS
2. Number of responders, defined as a decrease on the Y-BOCS >35%
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Secondary outcome measure(s)
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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 Impression (CGI)
7. Y-BOCS checklist
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Sources of funding
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Academic Medical Center (AMC)
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Trial website
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Publications
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2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20921122
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Contact name
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Dr
P.R.
Schuurman
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Address
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Academic Medical Center (AMC)
Department of Neurosurgery
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Tel
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+31 (0)20 5669111
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Email
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p.r.schuurman@amc.nl
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Sponsor
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Academic Medical Center (AMC) (The Netherlands)
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Address
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P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Date applied
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07/06/2006
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Last edited
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21/10/2010
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Date ISRCTN assigned
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07/06/2006
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