Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Procedure: Deep Brain Stimulation

• Registration Number: NCT00057603
• Lead Sponsor: University of Florida

Brief Summary

This study will evaluate the use of Deep Brain Stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-resistant obsessive compulsive disorder (OCD).

Detailed Description

Despite advances in pharmacological and behavioral therapies for OCD, a substantial number of patients fail to improve significantly following years of conventional and experimental interventions. For some patients, stereotactic neurosurgery is the only promising option available. Although this procedure has relatively few side effects in the majority of OCD patients and may lead to enduring benefits, its effects on brain tissue and function are irreversible. Bilateral deep brain stimulation (DBS) is an adjustable and partially reversible procedure that may be a more effective treatment for patients with OCD. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory OCD.

Participants receive DBS treatment for 30 months. Obsessive Compulsive scales, depression scales, neuropsychological evaluations, and surveys are used to assess participants.

Participants are monitored for 2 years after DBS treatment.

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2003-04-04
• Study First Submitted QC: 2003-04-04
• Study First Posted: 2003-04-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Intractable, malignant, and treatment refractory OCD that has caused substantial suffering and a reduction in the patient's psychosocial functioning for > 5 years
• Poor prognosis without neurosurgical intervention
• Failed an adequate trial of clomipramine and at least two of the following selective serotonin reuptake inhibitors (SSRIs): fluoxetine, fluvoxamine, citalopram, sertraline, and paroxetine. Additionally, patients must have failed augmentation treatment with at least one of the above drugs for 1 month with at least two of the following: clonazepam, haloperidol, risperidone, olanzapine, and gabapentin.
• Willingness to undergo augmentation treatment with a low-dose neuroleptic if tics are present prior to surgery
• Failed an adequate trial of cognitive behavioral therapy/exposure response prevention while taking clomipramine and an SSRI

Exclusion Criteria

• Current or lifetime Axis I diagnosis that substantially complicates function, treatment, or the subject's ability to comply with study procedures, or may lead to serious adverse events such as overdose, attempted suicide, or other potentially threatening behaviors
• Diagnosis and/or treatment for depression within the past year. Patients with a more distant history of depression will not be excluded.
• Previous neurosurgical procedure or AXIS III diagnosis of brain pathology
• Implants that contain electrical circuitry, generate electrical signals, and/or have metal parts
• Nonremovable body jewelry
• Anticoagulants or other medications that would put patients at risk for surgery-related complications
• Diathermy for physical therapy
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep Brain Stimulation	Participants receive deep brain stimulation treatment for 30 months.

Primary Outcome Measures

Name	Time	Method
Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey	Measured pre- and post-intervention

Trial Locations

Locations (1)

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States