Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Umeå University
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Yale-Brown Obsessive Compulsive Scale, Y-BOCS
Study Overview
Brief Summary
The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST).
The main research questions are:
- Does active DBS in BNST reduce OCD symptoms (primary outcome)?
- Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function?
The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The participant and the outcome assessor are blinded to whether the participant receives active or sham stimulation.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- •The patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug.
- •Severe OCD symptoms: YBOCS ≥ 25 points.
- •Substantial incapacity because of his/her symptoms.
- •Duration of symptoms: 5 years minimum.
- •Understand the consequences of participation in the study and give informed written consent.
Exclusion Criteria
- •Not being able to understand the consequences of the treatment.
- •Diagnosed with intellectual disability according to DSM-IV.
- •Not meeting the requirements for the neurosurgery procedure.
Arms & Interventions
Active stimulation
Deep brain stimulation - active stimulation
Intervention: Deep brain stimulation (Device)
Sham stimulation
Deep brain stimulation - no stimulation
Intervention: Deep brain stimulation (Device)
Outcomes
Primary Outcomes
Yale-Brown Obsessive Compulsive Scale, Y-BOCS
Time Frame: From enrollment to the end of treatment after 6 months.
Validated psychometric scale that measures symptoms of OCD.
Secondary Outcomes
- Hamilton Anxiety Scale, HAS(From enrollment to the end of treatment after 6 months.)
- Hamilton Depression scale, HAMD(From enrollment to the end of treatment after 6 months.)
- Montgomery Asberg Depression Rating Scale, MADRS(From enrollment to the end of treatment after 6 months.)
- Global Assessment of Functioning, GAF(From enrollment to the end of treatment after 6 months.)
- Clinical Global Impression rating scale, CGI(From enrollment to the end of treatment after 6 months.)