Obsessive-Compulsive DisorderPhase 2/3NCT02590445
Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder
A Phase 2/3 study testing deep brain stimulation system in people with Obsessive-Compulsive Disorder, run by Ruijin Hospital at 1 site in China.
Trial summary
Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most effective treatment for refractory OCD. However, the affecting area of traditional electrodes is limited and not specific to VC/VS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- deep brain stimulation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V).
- Chronic: at least a 3-year history of OCD symptoms with psychosocial dysfunction
- 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 or a score on Sheehan Disability Scale more than 24.
- Refractory: a lack of response to drug therapy after adequate administration, defined as more than two types of serotonin reuptake inhibitors at the maximum tolerated dose for more than 12 weeks. Adequate behavior therapy, defined as more than 20 sessions psychotherapy with experienced therapist.
- OCD medication regimen is stable for at least 4 weeks before enrollment.
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-TR criteria, as assessed with the use of the Structured Clinical Interview II.
- A current severe major depressive episode, determined according to DSM-V 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, or contraindications to surgery or anesthesia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Chencheng Zhang, MD, +86 18217122884, i@cczhang.com
About this study
Official title: Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder: A Pilot Study
Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most effective treatment for refractory OCD. However, the affecting area of traditional electrodes is limited and not specific to VC/VS. The investigators designed a novel electrode, 2 mental contacts(3mm contact-2mm space-3 mm contact) could be implanted in ventral striatum and the other upper 2 contacts(4mm space-3mm contact-4mm space-3mm contact)that can be implanted in ventral capsule simultaneously, which the investigators believe will be more effective due to better compatibly with anatomical features of target area. This trial is to evaluate the effectiveness and safety of this approach.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- deep brain stimulation system
- 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.
deep brain stimulation systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | Stimulator on followed by off Receives: Device: deep brain stimulation system |
| Sham stimulation | Sham comparator | Stimulator off followed by on Receives: Device: deep brain stimulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
Measured: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Secondary outcomes (13)
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score
Measured: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Adverse Events
Measured: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Measured: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Functional magnetic resonance imaging (fMRI) images
Measured: Baseline (preoperative)
Quality of life: Global assessment of function
Measured: Baseline (preoperative), 8 months, 12 months, 24 month
Disability: WHO disability assessment 2.0
Measured: Baseline (preoperative), 8 months, 12 months, 24 month
Neurobehavior Task (Decision making task, such as Model task, IGT)
Measured: Baseline (preoperative), 8 months, 12 months, 24 month
Neurobehavior Task (Working memory task, such as N-back)
Measured: Baseline (preoperative), 8 months, 12 months, 24 month
Disability: Sheehan Disability Scale
Measured: Baseline (preoperative), 8 months, 12 months, 24 month
Change in Obsessional beliefs questionnaire (OBQ-44) Score
Measured: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Change in Adult Temperament Questionnaire (ATQ-77) Score
Measured: Baseline (preoperative), 8 months, 12month, 24 month
Change in Temperament and Character Inventory Revised (TRI-R) Score
Measured: Baseline (preoperative), 8 months, 12month, 24 month
Cerebral glucose metabolism measured by PET-CT images
Measured: Baseline (preoperative), 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bomin Sun, Ruijin Hospital
- Investigators
- Bomin Sun, MD, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590445
- Sponsor's protocol ID
- OCD pilot
- Status last verified
- Dec 2016
- First submitted
- 26 Oct 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goodman WK, Foote KD, Greenberg BD, Ricciuti N, Bauer R, Ward H, Shapira NA, Wu SS, Hill CL, Rasmussen SA, Okun MS. Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Biol Psychiatry. 2010 Mar 15;67(6):535-42. doi: 10.1016/j.biopsych.2009.11.028. Epub 2010 Feb 8.
PubMed 20116047Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.
PubMed 19005196Denys D, Mantione M, Figee M, van den Munckhof P, Koerselman F, Westenberg H, Bosch A, Schuurman R. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch Gen Psychiatry. 2010 Oct;67(10):1061-8. doi: 10.1001/archgenpsychiatry.2010.122.
PubMed 20921122
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT02590445
- Acronym / sponsor ID
- OCD pilot
- Conditions
- Obsessive-Compulsive Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most effective treatment for refractory OCD. However, the affecting area of traditional electrodes is limited and not specific to VC/VS. The investigators designed a novel electrode, 2 mental contacts(3mm contact-2mm space-3 mm contact) could be implanted in ventral striatum and the other upper 2 contacts(4mm space-3mm contact-4mm space-3mm contact)that can be implanted in ventral capsule simultaneously, which the investigators believe will be more effective due to better compatibly with anatomical features of target area. This trial is to evaluate the effectiveness and safety of this approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: deep brain stimulation systemStimulator on followed by off |
| Sham stimulation | Sham comparator | Device: deep brain stimulation systemStimulator off followed by on |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 65 years.
- A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V).
- Chronic: at least a 3-year history of OCD symptoms with psychosocial dysfunction
- 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 or a score on Sheehan Disability Scale more than 24.
Key exclusion criteria (4 listed)
- 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-TR criteria, as assessed with the use of the Structured Clinical Interview II.
- A current severe major depressive episode, determined according to DSM-V 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, or contraindications to surgery or anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep brain stimulation system | Device | Active stimulation, Sham stimulation |
Primary outcome
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
Time frame: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
13 secondary outcomes
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score
Time frame: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Adverse Events
Time frame: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Time frame: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Functional magnetic resonance imaging (fMRI) images
Time frame: Baseline (preoperative)
Quality of life: Global assessment of function
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
Disability: WHO disability assessment 2.0
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
Neurobehavior Task (Decision making task, such as Model task, IGT)
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
Neurobehavior Task (Working memory task, such as N-back)
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
Disability: Sheehan Disability Scale
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
Change in Obsessional beliefs questionnaire (OBQ-44) Score
Time frame: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Change in Adult Temperament Questionnaire (ATQ-77) Score
Time frame: Baseline (preoperative), 8 months, 12month, 24 month
Change in Temperament and Character Inventory Revised (TRI-R) Score
Time frame: Baseline (preoperative), 8 months, 12month, 24 month
Cerebral glucose metabolism measured by PET-CT images
Time frame: Baseline (preoperative), 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Background: PubMed 20116047Goodman WK, Foote KD, Greenberg BD, Ricciuti N, Bauer R, Ward H, Shapira NA, Wu SS, Hill CL, Rasmussen SA, Okun MS. Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Biol Psychiatry. 2010 Mar 15;67(6):535-42. doi: 10.1016/j.biopsych.2009.11.028. Epub 2010 Feb 8.
- Background: PubMed 19005196Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.
- Background: PubMed 20921122Denys D, Mantione M, Figee M, van den Munckhof P, Koerselman F, Westenberg H, Bosch A, Schuurman R. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch Gen Psychiatry. 2010 Oct;67(10):1061-8. doi: 10.1001/archgenpsychiatry.2010.122.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bomin Sun, MD, PhD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing deep brain stimulation system in people with Obsessive-Compulsive Disorder, run by Ruijin Hospital at 1 site 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 7 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: status not confirmed, 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chencheng Zhang, MD (+8618217122884, i@cczhang.com), or a site near the patient. 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), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month). 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 NCT02590445, 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.