Deep Brain Stimulation for Patients with Treatment-Resistant Obsessive Compulsive Disorder: Identifying electrophysiological biomarkers

The University Of Queensland0 sites10 target enrollmentNovember 30, 2015

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: The University Of Queensland
Enrollment: 10
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Obsessive Compulsive Disorder (OCD) is a psychiatric condition that affects nearly 1-2% of the population. Its treatment is symptomatic and its symptoms have severe effects on quality of life. However a large number of patients are not responsive to the pharmacotherapy. This trial is to use Deep Brain Stimulation, an established therapy for movement disorders to manage the symptoms of treatment resistant OCD. We treated 9 patients in a randomised double blind trial. with very good outcomes

Registry

who.int

Start Date

November 30, 2015

End Date

July 29, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

The University Of Queensland

Eligibility Criteria

Inclusion Criteria

•To be eligible for participation in the study, patients must meet all of the following criteria:
•1\. Diagnosis \- Patient is diagnosed with primary obsessive\-compulsive disorder (OCD) according to DSM\-IV diagnostic criteria derived from the SCID.
•2\. Severity \- Patient has a Yale\-Brown Obsessive\-Compulsive scale (Y\-BOCS) score of more than or equal to 24, measured twice at least 2 weeks apart.
•3\. Chronicity \- Duration of illness greater than 5 years.
•4\. Treatment refractoriness – No or insufficient response following at least
•\* 2 treatment trials with an SSRI, at maximum tolerated dosage for at least 12 weeks plus
•\* 1 treatment trial with clomipramine at maximum tolerated dosage for at least 12 weeks plus
•\* 1 augmentation trial with an antipsychotic for 8 weeks in combination with the one of the abovementioned drugs plus
•\* 1 CBT trial (Exposure and response prevention or ERP), confirmed by patient or psychotherapist, for an adequate number of sessions as determined by a neuropsychiatrist.
•5\.Patient is aged between 18\-70 years.

Exclusion Criteria

•Patients with any of the following will not be eligible for enrolment:
•1\. A lifetime diagnosis of psychotic disorder, current or past (such as schizophrenia, schizoaffective disorder or delusional disorders).
•2\. Diagnosed manic episode within the last 3 years.
•3\. Clinical history consistent with severe personality disorder.
•4\. Current, or unstably remitted substance abuse disorder, the latter being defined by history consistent with substance dependence in the last 12 months, or abuse in the last 6 months, other than nicotine dependence or abuse.
•5\. Current clinically significant medical illness or neurological disorder, excluding tic disorder.
•6\. Clinically significant abnormality on pre\-operative MRI.
•7\.Any labelled contraindication to having DBS surgery, and/ or inability to undergo preoperative MRI.
•8\. Pregnancy.
•9\. Patient meets any of the following: