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Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

23 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep Brain Stimulation

Arm Description

Participants receive deep brain stimulation treatment for 30 months.

Outcomes

Primary Outcome Measures

Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey

Secondary Outcome Measures

Full Information

First Posted
April 4, 2003
Last Updated
November 8, 2011
Sponsor
University of Florida
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00057603
Brief Title
Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder
Official Title
Pilot Study of DBS for Treatment-Refractory OCD
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Participants receive deep brain stimulation treatment for 30 months.
Intervention Type
Procedure
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.
Primary Outcome Measure Information:
Title
Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey
Time Frame
Measured pre- and post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Ward, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22305344
Citation
Vora AK, Ward H, Foote KD, Goodman WK, Okun MS. Rebound symptoms following battery depletion in the NIH OCD DBS cohort: clinical and reimbursement issues. Brain Stimul. 2012 Oct;5(4):599-604. doi: 10.1016/j.brs.2011.10.004. Epub 2011 Nov 4.
Results Reference
derived
PubMed Identifier
20116047
Citation
Goodman WK, Foote KD, Greenberg BD, Ricciuti N, Bauer R, Ward H, Shapira NA, Wu SS, Hill CL, Rasmussen SA, Okun MS. Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Biol Psychiatry. 2010 Mar 15;67(6):535-42. doi: 10.1016/j.biopsych.2009.11.028. Epub 2010 Feb 8.
Results Reference
derived

Learn more about this trial

Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

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