Contact information
Type
Scientific
Primary contact
Dr P.R. Schuurman
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Neurosurgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5669111
p.r.schuurman@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
DBS in the nucleus accumbens can lead to long-term improvement of obsessive-compulsive symptoms and functioning, without unacceptable side-effects.
Ethics approval
Not provided at time of registration
Study design
Randomized, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Obsessive-compulsive disorder (OCD)
Intervention
Stereotactic implantation of bilateral DBS electrodes in the nucleus accumbens.
Placebo: no stimulation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Change on the Y-BOCS
2. Number of responders, defined as a decrease on the Y-BOCS >35%
Secondary outcome measures
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
Overall trial start date
27/03/2006
Overall trial end date
01/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16
Participant 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.
Recruitment start date
27/03/2006
Recruitment end date
01/07/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Funders
Funder type
University/education
Funder name
Academic Medical Center (AMC)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20921122
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23715912
Publication citations
-
Results
Denys D, Mantione M, Figee M, van den Munckhof P, Koerselman F, Westenberg H, Bosch A, Schuurman R, Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder., Arch. Gen. Psychiatry, 2010, 67, 10, 1061-1068, doi: 10.1001/archgenpsychiatry.2010.122.
-
Results
Ooms P, Mantione M, Figee M, Schuurman PR, van den Munckhof P, Denys D, Deep brain stimulation for obsessive-compulsive disorders: long-term analysis of quality of life., J. Neurol. Neurosurg. Psychiatr., 2014, 85, 2, 153-158, doi: 10.1136/jnnp-2012-302550.