Safety and Effectiveness of Capsulotomy in Refractory OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Safety and Effectiveness of Capsulotomy in Refractory Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02375152
• Other study ID #: 2014-14
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 24, 2015
• Last updated: April 25, 2015
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2015
• Source: Ruijin Hospital
• Contact: ChenCheng Zhang, MD
• Email: zhangchencheng[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Procedure:
• Anterior Capsulotomy

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Y-BOCS Score		Baseline (preoperative), 3 months, 6 months	No
Secondary	Change in Clinical Global Impressions Scale Score		Baseline (preoperative), 3 months, 6 months	No
Secondary	Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score		Baseline (preoperative), 3 months, 6 months	No
Secondary	Change in Temperament and Character Inventory revised version (TCI-R) Score		Baseline (preoperative), 3 months, 6 months	No
Secondary	Change in functional magnetic resonance imaging (fMRI) images		Baseline (preoperative), 3 months, 6 months	No
Secondary	Change in Psychophysical tasks( Iowa Gambling Task , Model Task, Working memory task )		Baseline (preoperative), 3 months, 6 months	No
Secondary	WHO disability assessment 2.0 (self, 12 terms)		Baseline (preoperative), 3 months, 6 months	No