MedPath

Deep brain stimulation for obsessive-compulsive disorder

Phase 3
Recruiting
Conditions
obsessive-compulsive disorder
OCD
10037176
Registration Number
NL-OMON50163
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

We will include patients who meet the following inclusion criteria:
- Obsessive compulsive disorder according to DSM-5 criteria
- At least one of the following conditions is met: 1) Y-BOCS score >= 28; 2)
Y--BOCS >= 14 in case of solely obsessions or compulsions; 3) Suffering from
obsessions or compulsions for at least 8 hours a day (i.e. a score of 4 on item
1 or item 6 of the Y-BOCS)
- Treatment refractoriness is defined as failure of all of the following: 1) at
least 2 different types of SSRI*s; 2) clomipramine; 3) addition of an
antipsychotic to either an SSRI or clomipramine; 4) an adequate trial of
cognitive-behavorial therapy given by a therapist who has experience with OCD;
all treatments should be given at therapeutic dosages for adequate duration. On
clinical grounds, exceptions to this definition are allowed, but only after
consultation with the coordinating center.
- Age: 18 years or older
- Motivated and capable to make the frequent visits to the outpatient clinic,
which are necessary for parameter optimization and the CBT.
- Mentally capable to understand the consequences of the procedure and make his
or her own choice without coercion

Exclusion Criteria

- Primary diagnosis in psychotic spectrum
- Unstable multiple sclerosis (MS)
- Acute brain damage (eg. recent hemorrhage or stroke)
- General contraindications to have surgery

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Change in obsessive-compulsive symptomes (measured as a change of Y-BOCS score<br /><br>compared to baseline)</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Depressive symptoms (measured with the Hamilton Depression Rating Scale)<br /><br>Adverse events<br /><br>DBS settings<br /><br>Medication use</p><br>
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