Obsessive-Compulsive Disorder
Conditions
Keywords
neurosurgery, capsulotomy
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.
Interventions
PROCEDUREAnterior Capsulotomy
Sponsors
National Natural Science Foundation of China
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Y-BOCS Score | Baseline (preoperative), 3 months, 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 |
| Change in functional magnetic resonance imaging (fMRI) images | Baseline (preoperative), 3 months, 6 months |
Countries
China
Contacts
Primary ContactChenCheng Zhang, MD
Backup ContactKristina Zeljic, MSc
Outcome results
None listed