A study on the effectiveness of Deep Brain Stimulation (DBS) in Treatment Refractory Obsessive-Compulsive Disorder (OCD)

St Vincent's0 sites12 target enrollmentOctober 29, 2012

Overview

No summary available.

Registry

who.int

Start Date

October 29, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•i) Male or female outpatients, aged 18 to 65 years, with a primary DSM\-IV diagnosis OCD.
•ii) Yale\-Brown Obsessive Compulsive Scale (Y\-BOCS) greater than or equal to 24, measured twice at least 2 weeks apart.
•iii) At least a 5\-year history of OCD and substantial functional impairment according to DSM\-IV criterion C and a Global Assessment of Function score of \<45\.
•iv) Refractoriness to therapy: defined as no response or insufficient response following at least 2 treatments with a selective serotonin reuptake inhibitor at maximum dosage for at least 12 weeks, plus 1 treatment with clomipramine hydrochloride at maximum dosage for at least 12 weeks, plus at least 1 augmentation trial with an atypical antipsychotic for 8 weeks in combination with an selective serotonin reuptake inhibitor, plus at least 1 Cognitive\-Behavioural Therapy (CBT) trial for a minimum of 16 sessions.

•i) Except for those with major depressive disorder and mild anxiety disorders, people 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) will be excluded from the study. The confirmation of the diagnosis of OCD and the exclusion of these diagnoses will require utilisation of the Structured Clinical Interview for DSM IV.
•ii) People with severe personality disorders, and clinically significant and unstable neurological or medical illnesses will be excluded.