China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study (CRODS)

China Refractory-Obsessive Compulsive Disorder Deep Brain Stimulation Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Device: Bilateral Nucleus Accumbens DBS (Suzhou Sceneray); Device: Sham Bilateral Nucleus Accumbens DBS

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510370
      • Guangzhou Psychiatric Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bilateral Nucleus Accumbens DBS; 6 month period of active bilateral nucleus accumbens DBS	Device: Bilateral Nucleus Accumbens DBS (Suzhou Sceneray); High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).; Other Names: Active DBS
Sham Comparator: Sham Bilateral Nucleus Accumbens DBS; 6 month period of sham bilateral nucleus accumbens DBS	Device: Sham Bilateral Nucleus Accumbens DBS; DBS system switched off.; Other Names: Sham DBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score	Baseline (preoperative), 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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
Change in functional magnetic resonance imaging (fMRI) images		Baseline (preoperative), 2 weeks after last ERP session (average)
Change in positron emission tomography (PET) brain glucose metabolism images	Fluoro-D-glucose (FDG) will be utilized to evaluate cerebral metabolism at Baseline (preoperative) and 6 months.	Baseline (preoperative), 6 months after surgery
Quality of life: Global assessment of function		Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery
Disability: WHO disability assessment 2.0		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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: National Natural Science Foundation of China; Icahn School of Medicine at Mount Sinai; Suzhou Sceneray Medical Co. , Ltd
• Investigators: Principal Investigator: Bomin Sun, MD,PhD, Ruijin Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: deep brain stimulation; neurosurgery; exposure response prevention
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: RCT-YY2015-CRODS