NCT02398318

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1.5 years

First QC Date

January 23, 2015

Last Update Submit

December 4, 2016

Conditions

Obsessive Compulsive Disorder

Keywords

neurosurgerydeep brain stimulationexposure response prevention

Outcome Measures

Primary Outcomes (1)

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

    Baseline (preoperative), 6 months

Secondary Outcomes (9)

  • 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)

  • +4 more secondary outcomes

Study Arms (2)

Bilateral Nucleus Accumbens DBS

ACTIVE COMPARATOR

6 month period of active bilateral nucleus accumbens DBS

Device: Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)

Sham Bilateral Nucleus Accumbens DBS

SHAM COMPARATOR

6 month period of sham bilateral nucleus accumbens DBS

Device: Sham Bilateral Nucleus Accumbens DBS

Interventions

Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)DEVICE

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

Also known as: Active DBS
Bilateral Nucleus Accumbens DBS
Sham Bilateral Nucleus Accumbens DBSDEVICE

DBS system switched off.

Also known as: Sham DBS
Sham Bilateral Nucleus Accumbens DBS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Guangzhou psychiatric hospital

Guangzhou, Guangdong, 510370, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (3)

  • 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.

    PMID: 23443174BACKGROUND

  • 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.

    PMID: 22743198BACKGROUND

  • Xiong B, Li B, Wen R, Gao Y, Gong F, Li D, Xu Y, Deng H, Xiao L, Yin S, Zhang W, Lozano AM, Wang W. Use of differential stimulation of the nucleus accumbens and anterior limb of the internal capsule to improve outcomes of obsessive-compulsive disorder. J Neurosurg. 2023 May 26;139(5):1376-1385. doi: 10.3171/2023.4.JNS221824. Print 2023 Nov 1.

    PMID: 37243560DERIVED

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Bomin Sun, MD,PhD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of functional neurosurgery department

Study Record Dates

First Submitted

January 23, 2015

First Posted

March 25, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2016

Study Completion

April 1, 2018

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

CN(3)