Clinical trial NCT06628752: Deep Brain Stimulation for Obsessive-compulsive Disorder
Official title: Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
Deep Brain Stimulation
Randomized Controlled Trial
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Västerbotten
First posted: 2024-10-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale, Y-BOCS
timeFrame: From enrollment to the end of treatment after 6 months.
Secondary outcomes:
measure: Hamilton Anxiety Scale, HAS
timeFrame: From enrollment to the end of treatment after 6 months.
measure: Hamilton Depression scale, HAMD
timeFrame: From enrollment to the end of treatment after 6 months.
measure: Montgomery Asberg Depression Rating Scale, MADRS
timeFrame: From enrollment to the end of treatment after 6 months.
measure: Global Assessment of Functioning, GAF
timeFrame: From enrollment to the end of treatment after 6 months.
measure: Clinical Global Impression rating scale, CGI
timeFrame: From enrollment to the end of treatment after 6 months.
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
state: Västerbotten
Study officials:
affiliation: Umeå University
name: Patric Blomstedt, Professor
role: STUDY_CHAIR
References: