Status:
UNKNOWN
Deep Brain Stimulation of the Bilateral Habenula for Treatment-Refractory Obsessive-Compulsive Disorder
Lead Sponsor:
Ruijin Hospital
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Deep brain stimulation (DBS) offers an effective and safe treatment for patients with debilitating, otherwise treatment-refractory obsessive-compulsive disorder(OCD). Although several target areas for...
Eligibility Criteria
Inclusion
- Diagnosed as having primary OCD according to DSM-IV criteria using the Structured Clinical Interview for DSM-IV Axis I disorders;
- YBOCSII score ≥31；
- Duration ≥2 years；
- Refractoriness to therapy was defined as no response or insufficient response following at least 2 treatments with adequate trials or intolerance to two or three selective serotonin transporter inhibitors (SSRIs) and clomipramine, augmentation strategies (antipsychotics) and cognitive behavioral therapy.
- Capacity to provide informed consent (understanding of the study purpose and methods.
Exclusion
- Except for those with major depressive disorder and mild anxiety disorders, patients with clinically significant comorbid DSM-IV diagnoses (such as schizophrenia, bipolar II disorder, alcohol or substance abuse in the last 6 months, current tic disorder, or body dysmorphic disorder)
- Patients with severe personality disorders, assessed using the Structured Clinical Interview for DSM-IV Axis II disorders.
- Serious and unstable organic diseases (e.g. unstable coronal heart disease);
- Pregnancy and/or lactation.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03463590
Start Date
March 1 2018
End Date
February 28 2020
Last Update
March 29 2018
Active Locations (1)
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1
Shanghai Ruijin Hospital Functional Neurosurgery
Shanghai, Shanghai Municipality, China, 200025