Clinical trial NCT02398318: China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study
Official title: China Refractory-Obsessive Compulsive Disorder Deep Brain Stimulation Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Obsessive Compulsive Disorder
Keywords: neurosurgery
deep brain stimulation
exposure response prevention
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Suzhou Sceneray Medical Co. , Ltd
name: National Natural Science Foundation of China
name: Icahn School of Medicine at Mount Sinai
First posted: 2015-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 60 years.
2. A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV).
3. Chronic: disease duration of more than 5 years.
4. 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.
5. Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45.
6. 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:

1. 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).
2. Cluster A or B personality disorder according to DSM-IV criteria, as assessed with the use of the Structured Clinical Interview II.
3. 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.
4. Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain; and no contraindications to surgery or anesthesia.

Primary outcomes:
measure: Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
timeFrame: Baseline (preoperative), 6 months
Secondary outcomes:
measure: Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
measure: Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17, Beck Anxiety Scale, Beck Depression Scale-1 Score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
measure: Change in Temperament and Character Inventory revised version (TCI-R) Score
timeFrame: Baseline (preoperative), 6 months, 24 months
measure: Iowa Gambling Task (change in task performance scores)
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
measure: Change in functional magnetic resonance imaging (fMRI) images
timeFrame: Baseline (preoperative), 2 weeks after last ERP session (average)
measure: Change in positron emission tomography (PET) brain glucose metabolism images
timeFrame: Baseline (preoperative), 6 months after surgery
measure: Quality of life: Global assessment of function
timeFrame: Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery
measure: Disability: WHO disability assessment 2.0
timeFrame: Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery
measure: Model Task (change in task performance scores)
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou psychiatric hospital
state: Guangdong
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: Ruijin Hospital
name: Bomin Sun, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zuo C, Ma Y, Sun B, Peng S, Zhang H, Eidelberg D, Guan Y. Metabolic imaging of bilateral anterior capsulotomy in refractory obsessive compulsive disorder: an FDG PET study. J Cereb Blood Flow Metab. 2013 Jun;33(6):880-7. doi: 10.1038/jcbfm.2013.23. Epub 2013 Feb 27.
citation: Wu H, Van Dyck-Lippens PJ, Santegoeds R, van Kuyck K, Gabriels L, Lin G, Pan G, Li Y, Li D, Zhan S, Sun B, Nuttin B. Deep-brain stimulation for anorexia nervosa. World Neurosurg. 2013 Sep-Oct;80(3-4):S29.e1-10. doi: 10.1016/j.wneu.2012.06.039. Epub 2012 Jun 25.