Obsessive-Compulsive DisorderPhase 2/3NCT02375152
Safety and Effectiveness of Capsulotomy in Refractory OCD
A Phase 2/3 study testing Anterior Capsulotomy in people with Obsessive-Compulsive Disorder, run by Ruijin Hospital at 1 site in China.
Trial summary
Obsessive-compulsive disorder (OCD) is a severely disabling psychiatric disorder with a worldwide lifetime prevalence of 2-3% (Islam et al., 2015).Despite the efficacy of pharmacological and behavioural treatment methods for most OCD patients, roughly one third do not demonstrate significant symptom improvement, even… 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?
- Anterior Capsulotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 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
- Obsessive compulsive disorder as the primary psychiatric diagnosis (according to DSM IV-criteria).
- Severity: Score higher than 25 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
- Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (refractory).
- 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, and clomipramine. Adequate psychotherapy, defined as continuously treatment for more than six months with a certified therapist .
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 HAMD-17 score of more than 20 and a risk of suicide.
- Abnormal cognitive status (measured by MoCA)
Trial locations and contacts
1 site in 1 country.
ChenCheng Zhang, MD contact
Kristina Zeljic, MSc contact
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Bomin Sun, MD,PhD, +86 13817777401, bominsun@sh163.net
About this study
Official title: Safety and Effectiveness of Capsulotomy in Refractory Obsessive-Compulsive Disorder
Obsessive-compulsive disorder (OCD) is a severely disabling psychiatric disorder with a worldwide lifetime prevalence of 2-3% (Islam et al., 2015).Despite the efficacy of pharmacological and behavioural treatment methods for most OCD patients, roughly one third do not demonstrate significant symptom improvement, even after aggressive treatment (Foa et al, 2007). The effectiveness of neurosurgical treatment methods (including ablative surgery) for those with severely disabling treatment resistant OCD is substantiated by clinical research (Greenberg, Rauch \& Haber, 2010). The brain target of this procedure is usually the area between the anterior and middle third of the anterior limb of the internal capsule.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Anterior Capsulotomy
- Keywords
- neurosurgery, capsulotomy
- 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.
Anterior CapsulotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgical Intervention | Experimental | Not described Receives: Procedure: Anterior Capsulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Y-BOCS Score
Measured: Baseline (preoperative), 3 months, 6 months
Secondary outcomes (6)
Change in Clinical Global Impressions Scale Score
Measured: Baseline (preoperative), 3 months, 6 months
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Measured: Baseline (preoperative), 3 months, 6 months
Change in Temperament and Character Inventory revised version (TCI-R) Score
Measured: Baseline (preoperative), 3 months, 6 months
Change in functional magnetic resonance imaging (fMRI) images
Measured: Baseline (preoperative), 3 months, 6 months
Change in Psychophysical tasks（ Iowa Gambling Task , Model Task, Working memory task ）
Measured: Baseline (preoperative), 3 months, 6 months
WHO disability assessment 2.0 (self, 12 terms)
Measured: Baseline (preoperative), 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Bomin Sun, Ruijin Hospital
- Investigators
- Bomin Sun, MD, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375152
- Sponsor's protocol ID
- 2014-14
- Status last verified
- Apr 2015
- First submitted
- 24 Feb 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Greenberg BD, Gabriels LA, Malone DA Jr, Rezai AR, Friehs GM, Okun MS, Shapira NA, Foote KD, Cosyns PR, Kubu CS, Malloy PF, Salloway SP, Giftakis JE, Rise MT, Machado AG, Baker KB, Stypulkowski PH, Goodman WK, Rasmussen SA, Nuttin BJ. Deep brain stimulation of the ventral internal capsule/ventral striatum for obsessive-compulsive disorder: worldwide experience. Mol Psychiatry. 2010 Jan;15(1):64-79. doi: 10.1038/mp.2008.55. Epub 2008 May 20.
PubMed 18490925Foa EB, Liebowitz MR, Kozak MJ, Davies S, Campeas R, Franklin ME, Huppert JD, Kjernisted K, Rowan V, Schmidt AB, Simpson HB, Tu X. Randomized, placebo-controlled trial of exposure and ritual prevention, clomipramine, and their combination in the treatment of obsessive-compulsive disorder. Am J Psychiatry. 2005 Jan;162(1):151-61. doi: 10.1176/appi.ajp.162.1.151.
PubMed 15625214Pepper J, Hariz M, Zrinzo L. Deep brain stimulation versus anterior capsulotomy for obsessive-compulsive disorder: a review of the literature. J Neurosurg. 2015 May;122(5):1028-37. doi: 10.3171/2014.11.JNS132618. Epub 2015 Jan 30.
PubMed 25635480
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Capsulotomy in Refractory Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02375152
- Acronym / sponsor ID
- 2014-14
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- neurosurgery, capsulotomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Apr 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Mar 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.
Obsessive-compulsive disorder (OCD) is a severely disabling psychiatric disorder with a worldwide lifetime prevalence of 2-3% (Islam et al., 2015).Despite the efficacy of pharmacological and behavioural treatment methods for most OCD patients, roughly one third do not demonstrate significant symptom improvement, even after aggressive treatment (Foa et al, 2007). The effectiveness of neurosurgical treatment methods (including ablative surgery) for those with severely disabling treatment resistant OCD is substantiated by clinical research (Greenberg, Rauch \& Haber, 2010). The brain target of this procedure is usually the area between the anterior and middle third of the anterior limb of the internal capsule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Intervention | Experimental | Procedure: Anterior Capsulotomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obsessive compulsive disorder as the primary psychiatric diagnosis (according to DSM IV-criteria).
- Severity: Score higher than 25 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
- Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (refractory).
- 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, and clomipramine. Adequate psychotherapy, defined as continuously treatment for more than six months with a certified therapist .
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 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 HAMD-17 score of more than 20 and a risk of suicide.
- Abnormal cognitive status (measured by MoCA)
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 |
|---|---|---|
| Anterior Capsulotomy | Procedure or surgery | Surgical Intervention |
Primary outcome
Change in Y-BOCS Score
Time frame: Baseline (preoperative), 3 months, 6 months
6 secondary outcomes
Change in Clinical Global Impressions Scale Score
Time frame: Baseline (preoperative), 3 months, 6 months
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Time frame: Baseline (preoperative), 3 months, 6 months
Change in Temperament and Character Inventory revised version (TCI-R) Score
Time frame: Baseline (preoperative), 3 months, 6 months
Change in functional magnetic resonance imaging (fMRI) images
Time frame: Baseline (preoperative), 3 months, 6 months
Change in Psychophysical tasks（ Iowa Gambling Task , Model Task, Working memory task ）
Time frame: Baseline (preoperative), 3 months, 6 months
WHO disability assessment 2.0 (self, 12 terms)
Time frame: Baseline (preoperative), 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Background: PubMed 18490925Greenberg BD, Gabriels LA, Malone DA Jr, Rezai AR, Friehs GM, Okun MS, Shapira NA, Foote KD, Cosyns PR, Kubu CS, Malloy PF, Salloway SP, Giftakis JE, Rise MT, Machado AG, Baker KB, Stypulkowski PH, Goodman WK, Rasmussen SA, Nuttin BJ. Deep brain stimulation of the ventral internal capsule/ventral striatum for obsessive-compulsive disorder: worldwide experience. Mol Psychiatry. 2010 Jan;15(1):64-79. doi: 10.1038/mp.2008.55. Epub 2008 May 20.
- Background: PubMed 15625214Foa EB, Liebowitz MR, Kozak MJ, Davies S, Campeas R, Franklin ME, Huppert JD, Kjernisted K, Rowan V, Schmidt AB, Simpson HB, Tu X. Randomized, placebo-controlled trial of exposure and ritual prevention, clomipramine, and their combination in the treatment of obsessive-compulsive disorder. Am J Psychiatry. 2005 Jan;162(1):151-61. doi: 10.1176/appi.ajp.162.1.151.
- Background: PubMed 25635480Pepper J, Hariz M, Zrinzo L. Deep brain stimulation versus anterior capsulotomy for obsessive-compulsive disorder: a review of the literature. J Neurosurg. 2015 May;122(5):1028-37. doi: 10.3171/2014.11.JNS132618. Epub 2015 Jan 30.
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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.
ChenCheng Zhang, MD contact
Kristina Zeljic, MSc contact
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 Anterior Capsulotomy 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 4 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 28 Apr 2015. 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. 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 (zhangchencheng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Y-BOCS Score (time frame: Baseline (preoperative), 3 months, 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 NCT02375152, 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 28 Apr 2015.