Back to resultsSafety and Effectiveness of Capsulotomy in Refractory OCD
Primary Purpose
Obsessive-Compulsive Disorder
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anterior Capsulotomy
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring neurosurgery, capsulotomy
Eligibility Criteria
Inclusion Criteria:
- 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 .
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 HAMD-17 score of more than 20 and a risk of suicide.
- Abnormal cognitive status (measured by MoCA)
Sites / Locations
- Shanghai Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgical Intervention
Arm Description
Outcomes
Primary Outcome Measures
Change in Y-BOCS Score
Secondary Outcome Measures
Change in Clinical Global Impressions Scale Score
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Change in Temperament and Character Inventory revised version (TCI-R) Score
Change in functional magnetic resonance imaging (fMRI) images
Change in Psychophysical tasks（ Iowa Gambling Task , Model Task, Working memory task ）
WHO disability assessment 2.0 (self, 12 terms)
Full Information
NCT ID
NCT02375152
First Posted
February 24, 2015
Last Updated
April 25, 2015
Sponsor
Ruijin Hospital
Collaborators
National Natural Science Foundation of China
1. Study Identification
Unique Protocol Identification Number
NCT02375152
Brief Title
Safety and Effectiveness of Capsulotomy in Refractory OCD
Official Title
Safety and Effectiveness of Capsulotomy in Refractory Obsessive-Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
National Natural Science Foundation of China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
neurosurgery, capsulotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical Intervention
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Anterior Capsulotomy
Primary Outcome Measure Information:
Title
Change in Y-BOCS Score
Time Frame
Baseline (preoperative), 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impressions Scale Score
Time Frame
Baseline (preoperative), 3 months, 6 months
Title
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Time Frame
Baseline (preoperative), 3 months, 6 months
Title
Change in Temperament and Character Inventory revised version (TCI-R) Score
Time Frame
Baseline (preoperative), 3 months, 6 months
Title
Change in functional magnetic resonance imaging (fMRI) images
Time Frame
Baseline (preoperative), 3 months, 6 months
Title
Change in Psychophysical tasks（ Iowa Gambling Task , Model Task, Working memory task ）
Time Frame
Baseline (preoperative), 3 months, 6 months
Title
WHO disability assessment 2.0 (self, 12 terms)
Time Frame
Baseline (preoperative), 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 .
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 HAMD-17 score of more than 20 and a risk of suicide.
Abnormal cognitive status (measured by MoCA)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ChenCheng Zhang, MD
Email
zhangchencheng@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Zeljic, MSc
Email
kristina1315@hotmail.com
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
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bomin Sun, MD,PhD
Phone
+86 13817777401
Email
bominsun@sh163.net
12. IPD Sharing Statement
Citations:
PubMed Identifier
18490925
Citation
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.
Results Reference
background
PubMed Identifier
15625214
Citation
Foa 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.
Results Reference
background
PubMed Identifier
25635480
Citation
Pepper 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.
Results Reference
background
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Safety and Effectiveness of Capsulotomy in Refractory OCD
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