Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00057603

Purpose

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).

Condition	Intervention
Obsessive-Compulsive Disorder	Procedure: Deep Brain Stimulation

MedlinePlus related topics: Obsessive-Compulsive Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of DBS for Treatment-Refractory OCD

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey [ Time Frame: Measured pre- and post-intervention ] [ Designated as safety issue: Yes ]

Enrollment:	6
Study Start Date:	January 2001
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Deep Brain Stimulation: Experimental Participants receive deep brain stimulation treatment for 30 months.	Procedure: Deep Brain Stimulation Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.

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.

Eligibility

Ages Eligible for Study:	23 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057603

Locations

United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Herbert Ward, MD

University of Florida College of Medicine

More Information

Responsible Party:	University of Florida College of Medicine ( Herbert Ward, MD )
Study ID Numbers:	R21 MH64161, DATR A5-ETMA
Study First Received:	April 4, 2003
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00057603
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009