Safety and Effectiveness of Capsulotomy in Refractory OCD

NCT02375152 | Unknown Phase 2 DMC

• 1 other identifier: 2014-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

neurosurgery; capsulotomy

Outcome Measures

Primary Outcomes (1)

• Change in Y-BOCS Score

  Baseline (preoperative), 3 months, 6 months

Secondary Outcomes (6)

• 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

Study Arms (1)

Surgical Intervention

EXPERIMENTAL

Procedure: Anterior Capsulotomy

Interventions

Anterior Capsulotomy PROCEDURE

Surgical Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ruijin Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 18490925 BACKGROUND

• 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.

  PMID: 15625214 BACKGROUND

• 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.

  PMID: 25635480 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Bomin Sun, MD, PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChenCheng Zhang, MD

CONTACT

zhangchencheng@hotmail.com

Kristina Zeljic, MSc

CONTACT

kristina1315@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Functional Neurosurgery

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 2, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

CN (1)