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

Primary Purpose

Obsessive Compulsive Disorder

Status

Withdrawn

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)

Sham Bilateral Nucleus Accumbens DBS

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring neurosurgery, deep brain stimulation, exposure response prevention

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Guangzhou psychiatric hospital
Shanghai Mental Health Center
West China Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Bilateral Nucleus Accumbens DBS

Sham Bilateral Nucleus Accumbens DBS

Arm Description

6 month period of active bilateral nucleus accumbens DBS

6 month period of sham bilateral nucleus accumbens DBS

Outcomes

Primary Outcome Measures

Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score

Secondary Outcome Measures

Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score

Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17, Beck Anxiety Scale, Beck Depression Scale-1 Score

Change in Temperament and Character Inventory revised version (TCI-R) Score

Iowa Gambling Task (change in task performance scores)

Change in functional magnetic resonance imaging (fMRI) images

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.

Quality of life: Global assessment of function

Disability: WHO disability assessment 2.0

Model Task (change in task performance scores)

Full Information

NCT ID

NCT02398318

First Posted

January 23, 2015

Last Updated

December 4, 2016

Sponsor

Ruijin Hospital

Collaborators

Suzhou Sceneray Medical Co. , Ltd, National Natural Science Foundation of China, Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT02398318

Brief Title

China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study

Acronym

CRODS

Official Title

China Refractory-Obsessive Compulsive Disorder Deep Brain Stimulation Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Withdrawn

Why Stopped

A pilot study is recruiting

Study Start Date

April 2015 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

Collaborators

Suzhou Sceneray Medical Co. , Ltd, National Natural Science Foundation of China, Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive Compulsive Disorder

Keywords

neurosurgery, deep brain stimulation, exposure response prevention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bilateral Nucleus Accumbens DBS

Arm Type

Active Comparator

Arm Description

6 month period of active bilateral nucleus accumbens DBS

Arm Title

Sham Bilateral Nucleus Accumbens DBS

Arm Type

Sham Comparator

Arm Description

6 month period of sham bilateral nucleus accumbens DBS

Intervention Type

Device

Intervention Name(s)

Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)

Other Intervention Name(s)

Active DBS

Intervention Description

High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).

Intervention Type

Device

Intervention Name(s)

Sham Bilateral Nucleus Accumbens DBS

Other Intervention Name(s)

Sham DBS

Intervention Description

DBS system switched off.

Primary Outcome Measure Information:

Title

Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score

Time Frame

Baseline (preoperative), 6 months

Secondary Outcome Measure Information:

Title

Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score

Time Frame

Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Title

Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17, Beck Anxiety Scale, Beck Depression Scale-1 Score

Time Frame

Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Title

Change in Temperament and Character Inventory revised version (TCI-R) Score

Time Frame

Baseline (preoperative), 6 months, 24 months

Title

Iowa Gambling Task (change in task performance scores)

Time Frame

Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Title

Change in functional magnetic resonance imaging (fMRI) images

Time Frame

Baseline (preoperative), 2 weeks after last ERP session (average)

Title

Change in positron emission tomography (PET) brain glucose metabolism images

Description

Fluoro-D-glucose (FDG) will be utilized to evaluate cerebral metabolism at Baseline (preoperative) and 6 months.

Time Frame

Baseline (preoperative), 6 months after surgery

Title

Quality of life: Global assessment of function

Time Frame

Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery

Title

Disability: WHO disability assessment 2.0

Time Frame

Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery

Title

Model Task (change in task performance scores)

Time Frame

Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bomin Sun, MD,PhD

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangzhou psychiatric hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510370

Country

China

Facility Name

Shanghai Mental Health Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

West China Hospital

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23443174

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.

Results Reference

background

PubMed Identifier

22743198

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.

Results Reference

background

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China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study

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