Safety and Effectiveness of Capsulotomy in Refractory OCD

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02375152
• Collaborator: National Natural Science Foundation of China (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 44
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Procedure: Anterior Capsulotomy	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Effectiveness of Capsulotomy in Refractory Obsessive-Compulsive Disorder
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgical Intervention	Procedure: Anterior Capsulotomy

Outcome Measures

Primary Outcome Measures

1. Change in Y-BOCS Score [Baseline (preoperative), 3 months, 6 months]

Secondary Outcome Measures

1. Change in Clinical Global Impressions Scale Score [Baseline (preoperative), 3 months, 6 months]

2. Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score [Baseline (preoperative), 3 months, 6 months]

3. Change in Temperament and Character Inventory revised version (TCI-R) Score [Baseline (preoperative), 3 months, 6 months]

4. Change in functional magnetic resonance imaging (fMRI) images [Baseline (preoperative), 3 months, 6 months]

5. Change in Psychophysical tasks（ Iowa Gambling Task , Model Task, Working memory task ） [Baseline (preoperative), 3 months, 6 months]

6. WHO disability assessment 2.0 (self, 12 terms) [Baseline (preoperative), 3 months, 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Obsessive compulsive disorder as the primary psychiatric diagnosis (according to DSM IV-criteria).

2. Severity: Score higher than 25 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).

3. Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (refractory).

4. 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:

1. 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);

2. Cluster A or B personality disorder according to DSM-IV criteria, as assessed with the use of the Structured Clinical Interview II.

3. 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.

4. Abnormal cognitive status (measured by MoCA)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Ruijin Hospital	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

• Ruijin Hospital
• National Natural Science Foundation of China

Investigators

• Principal Investigator: Bomin Sun, MD, PhD, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Review.

• Responsible Party: Bomin Sun, Director of the Department of Functional Neurosurgery, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT02375152
• Other Study ID Numbers: 2014-14
• First Posted: Mar 2, 2015
• Last Update Posted: Apr 28, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Bomin Sun, Director of the Department of Functional Neurosurgery, Ruijin Hospital: neurosurgery; capsulotomy
• Additional relevant MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder

Study Results

No Results Posted as of Apr 28, 2015