Obsessive-Compulsive Disorder
Conditions
Keywords
Obsessive-Compulsive Disorder, Deep Brain Stimulation, Randomized Controlled Trial
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.
Interventions
DEVICEDeep brain stimulation
Stimulation through a device implanted bilaterally into deep brain structures.
Sponsors
Region Västerbotten
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant and the outcome assessor are blinded to whether the participant receives active or sham stimulation.
Intervention model description
Randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale-Brown Obsessive Compulsive Scale, Y-BOCS | From enrollment to the end of treatment after 6 months. | Validated psychometric scale that measures symptoms of OCD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Scale, HAS | From enrollment to the end of treatment after 6 months. | Validated psychometric scale that measures symptoms of anxiety. |
| Hamilton Depression scale, HAMD | From enrollment to the end of treatment after 6 months. | Validated psychometric scale that measures symptoms of depression. |
| Montgomery Asberg Depression Rating Scale, MADRS | From enrollment to the end of treatment after 6 months. | Validated psychometric scale that measures symptoms of depression. |
| Global Assessment of Functioning, GAF | From enrollment to the end of treatment after 6 months. | Scale that measures level of functioning. |
| Clinical Global Impression rating scale, CGI | From enrollment to the end of treatment after 6 months. | Scale that measures symptom improvement. |
Countries
Sweden
Contacts
Primary ContactViktoria Johansson, PhD
Backup ContactMatilda Naesstrom, PhD
Outcome results
None listed