Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Safety and Effectiveness of Capsulotomy in Refractory OCD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02375152
Recruitment Status : Unknown
Verified April 2015 by Bomin Sun, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : March 2, 2015
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Bomin Sun, Ruijin Hospital

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in Y-BOCS Score [ Time Frame: Baseline (preoperative), 3 months, 6 months ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375152


Contacts
Layout table for location contacts
Contact: ChenCheng Zhang, MD zhangchencheng@hotmail.com
Contact: Kristina Zeljic, MSc kristina1315@hotmail.com

Locations
Layout table for location information
China, Shanghai
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Bomin Sun, MD,PhD    +86 13817777401    bominsun@sh163.net   
Sponsors and Collaborators
Ruijin Hospital
National Natural Science Foundation of China
Investigators
Layout table for investigator information
Principal Investigator: Bomin Sun, MD, PhD Ruijin Hospital

Publications:
Layout table for additonal information
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: March 2, 2015    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by Bomin Sun, Ruijin Hospital:
neurosurgery
capsulotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders