Effectiveness of Deep Brain Stimulation for Treating People With Treatment Resistant Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Active DBS; Sham DBS
Intervention description: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.; In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Deep Brain Stimulation; Treatment Refractory; Ventral Internal Capsule/Ventral Striatum; Neurosurgery; Neuroimaging

Summary:

      This study will evaluate the safety and effectiveness of deep brain stimulation in treating
      people with severe and otherwise treatment-resistant obsessive-compulsive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obsessive-compulsive disorder (OCD), diagnosed by Structured Clinical Interview for
             DSM-IV (SCID-IV)

          -  Presence of disabling severity, as assessed by a Yale-Brown Obsessive Compulsive Scale
             (YBOCS) score of at least 30

          -  Impaired functioning, indicated by a Global Assessment of Functioning (GAF) score of
             45 or less

          -  Documented highly treatment refractory illness; the documentation must demonstrate
             persistence of severe symptoms and impairment for 5 or more years despite at least
             three first-line and two second-line treatments, as follows:

               1. at least three adequate trials of, or documented intolerance to, different
                  serotonin transporter inhibitors (e.g., fluoxetine, sertraline, fluvoxamine,
                  paroxetine, citalopram, escitalopram, clomipramine) for at least 3 months at the
                  maximum tolerated dose. These trials may include any of the agents above, but
                  must include an adequate course of clomipramine, either alone or in combination
                  with a more selective serotonin transporter inhibitor;

               2. augmentation of one of the selective serotonin transporter inhibitors with
                  clomipramine, and a neuroleptic (each for at least 2 weeks); and

               3. adequate behavior therapy (more than 20 sessions of exposure and response
                  prevention by a therapist with substantial expertise in OCD treatment as
                  determined by the investigators) with at least one of these trials and tried in
                  combination with medication therapy

          -  Either drug free or on a stable drug regimen for at least 6 weeks before study entry

          -  General good overall health

          -  If possible, has a family member or significant other who sees the participant
             regularly, can communicate with the study team as needed, and, if necessary, can
             attend study visits

          -  Local referring psychiatrist willing to provide ongoing care during and after the
             trial, to work closely with the research team, and to agree that the study
             psychiatrist will prescribe medications during the 3-month masked phase

          -  Platelet count greater than 125,000 per cubic millimeter and a prothrombin time and
             partial thromboplastin time within normal limits

        Exclusion Criteria:

          -  Current or past psychotic disorder

          -  Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WASI), or
             cognitive impairment that would affect a participant's ability to give informed
             consent or provide interview or self-report data reliably, as determined by the
             Consent Monitor and the site psychiatrist.

          -  A clinical history of bipolar mood disorder

          -  Any current clinically significant neurological disorder or medical illness affecting
             brain function, other than a tic disorder

          -  Any clinically significant abnormality on preoperative MRI

          -  Any labeled DBS contraindication, inability to undergo presurgical MRI (e.g., cardiac
             pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy,
             inability to undergo an awake operation, significant cardiac risk factors, or other
             medical risk factors for surgery

          -  Current or unstable remitted substance abuse or dependence

          -  Positive urine toxicology screen for substance abuse

          -  Pregnant and/or woman of childbearing age not using effective forms of birth control

          -  Clinical history of severe personality disorder

          -  An inability to control suicide attempts, imminent risk of suicide in the
             investigator's judgment, or a history of serious suicidal behavior, which is defined
             using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more
             actual suicide attempts in the 3 years before study entry with the lethality rated at
             3 or higher, or (2) one or more interrupted suicide attempts with a potential
             lethality judged to result in serious injury or death

          -  Current diagnosis of body dysmorphic disorder

          -  Evidence of dementia of other significant cognitive impairment on neuropsychological
             evaluation