Safety and Effectiveness of Capsulotomy in Refractory OCD

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.

Study Overview

• Status: Unknown
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Procedure: Anterior Capsulotomy

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: ChenCheng Zhang, MD; Email: zhangchencheng@hotmail.com
• Study Contact Backup: Name: Kristina Zeljic, MSc; Email: kristina1315@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Shanghai Ruijin Hospital
      • Contact: Bomin Sun, MD,PhD; Phone Number: +86 13817777401; Email: bominsun@sh163.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Y-BOCS Score	Baseline (preoperative), 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Clinical Global Impressions Scale Score	Baseline (preoperative), 3 months, 6 months
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score	Baseline (preoperative), 3 months, 6 months
Change in Temperament and Character Inventory revised version (TCI-R) Score	Baseline (preoperative), 3 months, 6 months
Change in functional magnetic resonance imaging (fMRI) images	Baseline (preoperative), 3 months, 6 months
Change in Psychophysical tasks（ Iowa Gambling Task , Model Task, Working memory task ）	Baseline (preoperative), 3 months, 6 months
WHO disability assessment 2.0 (self, 12 terms)	Baseline (preoperative), 3 months, 6 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: National Natural Science Foundation of China

Publications and helpful links

General 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. doi: 10.1176/appi.ajp.162.1.151.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 25, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: neurosurgery; capsulotomy
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2014-14