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Obsessive Compulsive DisorderPhase 2/3CRODSNCT02398318

China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study

A Phase 2/3 study testing Bilateral Nucleus Accumbens DBS (Suzhou Sceneray) in people with Obsessive Compulsive Disorder, run by Ruijin Hospital at 3 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obsessive Compulsive Disorder
What is being tested?
Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
3 sitesChina
Study dates
Apr 2015to Apr 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • West China Hospital

    Chengdu, Sichuan, 610041

  • Guangzhou psychiatric hospital

    Guangzhou, Guangdong, 510370

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: 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.

Being tested
Bilateral Nucleus Accumbens DBS (Suzhou Sceneray), Sham Bilateral Nucleus Accumbens DBS
Keywords
neurosurgery, deep brain stimulation, exposure response prevention
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)Device

    Also called Active DBS

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

  • Sham Bilateral Nucleus Accumbens DBSDevice

    Also called Sham DBS

    DBS system switched off.

Study groups in NCT02398318
Study groupRoleWhat they receive
Bilateral Nucleus Accumbens DBSActive comparator6 month period of active bilateral nucleus accumbens DBS
Receives: Device: Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)
Sham Bilateral Nucleus Accumbens DBSSham comparator6 month period of sham bilateral nucleus accumbens DBS
Receives: Device: Sham Bilateral Nucleus Accumbens DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline (preoperative), 6 months

Secondary outcomes (9)

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

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

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

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

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

    Measured: Baseline (preoperative), 6 months, 24 months

  4. Iowa Gambling Task (change in task performance scores)

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

  5. Change in functional magnetic resonance imaging (fMRI) images

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

  6. 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.

    Measured: Baseline (preoperative), 6 months after surgery

  7. Quality of life: Global assessment of function

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

  8. Disability: WHO disability assessment 2.0

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

  9. Model Task (change in task performance scores)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionOct 2016 (estimated)
  4. Study completionApr 2018 (estimated)

Why it stopped: A pilot study is recruiting

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02398318
Sponsor's protocol ID
RCT-YY2015-CRODS
Acronym
CRODS
Status last verified
Dec 2016
First submitted
23 Jan 2015
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 23443174

  • 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.

    PubMed 22743198

  • 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.

    PubMed 37243560

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Bilateral Nucleus Accumbens DBS (Suzhou Sceneray) in people with Obsessive Compulsive Disorder, run by Ruijin Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score (time frame: Baseline (preoperative), 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02398318, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.

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CRODS Clinical Trial NCT02398318 | AzTrials