China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study

Obsessive Compulsive Disorder Clinical Trial

— CRODS  

Official title:

China Refractory-Obsessive Compulsive Disorder Deep Brain Stimulation Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02398318
• Other study ID #: RCT-YY2015-CRODS
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: January 23, 2015
• Last updated: December 4, 2016
• Start date: April 2015
• Est. completion date: April 2018

Study information

• Verified date: December 2016
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Device:
• Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)
High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).
• Sham Bilateral Nucleus Accumbens DBS
DBS system switched off.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan
China	Guangzhou psychiatric hospital	Guangzhou	Guangdong
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Ruijin Hospital	Icahn School of Medicine at Mount Sinai, National Natural Science Foundation of China, Suzhou Sceneray Medical Co. , Ltd

Country where clinical trial is conducted

China, 

References & Publications (2)

Wu H, Van Dyck-Lippens PJ, Santegoeds R, van Kuyck K, Gabriëls 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score		Baseline (preoperative), 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	Change in Temperament and Character Inventory revised version (TCI-R) Score		Baseline (preoperative), 6 months, 24 months	No
Secondary	Iowa Gambling Task (change in task performance scores)		Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months	No
Secondary	Change in functional magnetic resonance imaging (fMRI) images		Baseline (preoperative), 2 weeks after last ERP session (average)	No
Secondary	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	No
Secondary	Quality of life: Global assessment of function		Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery	No
Secondary	Disability: WHO disability assessment 2.0		Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery	No
Secondary	Model Task (change in task performance scores)		Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months	No