Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00057603
First received: April 4, 2003
Last updated: November 8, 2011
Last verified: November 2011
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of DBS for Treatment-Refractory OCD

Resource links provided by NLM:


Further study details as provided by University of Florida:

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
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep Brain Stimulation
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Florida
Investigators
Principal Investigator: Herbert Ward, MD University of Florida
  More Information

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00057603     History of Changes
Other Study ID Numbers: R21 MH64161, R21MH064161, DATR A5-ETMA
Study First Received: April 4, 2003
Last Updated: November 8, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 20, 2014