Condition category
Mental and Behavioural Disorders
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
30/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes