Safety and Effectiveness of Capsulotomy in Refractory OCD

Phase 2

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Procedure: Anterior Capsulotomy

• Registration Number: NCT02375152
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Status Verified: 2015-04
• Study Start: 2015-04
• Last Update Submitted: 2015-04-25
• Last Update Posted: 2015-04-28
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical Intervention	Anterior Capsulotomy	-

Primary Outcome Measures

Name	Time	Method
Change in Y-BOCS Score	Baseline (preoperative), 3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
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 Clinical Global Impressions Scale 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

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China