China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study
Phase 2
Withdrawn
- Conditions
- Obsessive Compulsive Disorder
- Interventions
- Device: Sham Bilateral Nucleus Accumbens DBSDevice: Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)
- Registration Number
- NCT02398318
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of the nucleus accumbens is the most tested therapeutic avenue for refractory OCD. However, large scale randomized controlled trials to evaluate the effectiveness of this approach are rare.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Age between 18 and 60 years.
- A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV).
- Chronic: disease duration of more than 5 years.
- Severity: a score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of more than 25 or one subscale score of more than 15 ; a score for severity of illness on the Clinical Global Impression (CGI) scale of more than 4.
- Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45.
- Refractory: a lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least three serotonin-reuptake inhibitors, one of which had to be clomipramine. Adequate behavior therapy, defined as 20 sessions of exposure and response prevention (ERP) with a therapist who has substantial expertise in OCD treatment.
Exclusion Criteria
- Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0).
- Cluster A or B personality disorder according to DSM-IV criteria, as assessed with the use of the Structured Clinical Interview II.
- A current severe major depressive episode, determined according to DSM-IV criteria (as assessed with the use of the MINI 6.0.0) and defined by the Hamilton Depression Rating Scale-17 (HAMD) score of more than 20 and a risk of suicide.
- Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain; and no contraindications to surgery or anesthesia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Bilateral Nucleus Accumbens DBS Sham Bilateral Nucleus Accumbens DBS 6 month period of sham bilateral nucleus accumbens DBS Bilateral Nucleus Accumbens DBS Bilateral Nucleus Accumbens DBS (Suzhou Sceneray) 6 month period of active bilateral nucleus accumbens DBS
- Primary Outcome Measures
Name Time Method Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score Baseline (preoperative), 6 months
- Secondary Outcome Measures
Name Time Method Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17, Beck Anxiety Scale, Beck Depression Scale-1 Score Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months Change in positron emission tomography (PET) brain glucose metabolism images Baseline (preoperative), 6 months after surgery Fluoro-D-glucose (FDG) will be utilized to evaluate cerebral metabolism at Baseline (preoperative) and 6 months.
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months Change in Temperament and Character Inventory revised version (TCI-R) Score Baseline (preoperative), 6 months, 24 months Iowa Gambling Task (change in task performance scores) Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months Disability: WHO disability assessment 2.0 Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery Change in functional magnetic resonance imaging (fMRI) images Baseline (preoperative), 2 weeks after last ERP session (average) Quality of life: Global assessment of function Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery Model Task (change in task performance scores) Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Trial Locations
- Locations (3)
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China
West China Hospital
🇨🇳Chengdu, Sichuan, China
Guangzhou psychiatric hospital
🇨🇳Guangzhou, Guangdong, China