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Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00057603
Recruitment Status : Completed
First Posted : April 8, 2003
Last Update Posted : November 9, 2011
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE April 4, 2003
First Posted Date  ICMJE April 8, 2003
Last Update Posted Date November 9, 2011
Study Start Date  ICMJE January 2001
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2008)
Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey [ Time Frame: Measured pre- and post-intervention ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder
Official Title  ICMJE Pilot Study of DBS for Treatment-Refractory OCD
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE Procedure: Deep Brain Stimulation
Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.
Study Arms  ICMJE Experimental: Deep Brain Stimulation
Participants receive deep brain stimulation treatment for 30 months.
Intervention: Procedure: Deep Brain Stimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
6
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00057603
Other Study ID Numbers  ICMJE R21MH064161( U.S. NIH Grant/Contract )
R21MH064161 ( U.S. NIH Grant/Contract )
DATR A5-ETMA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Herbert Ward, MD University of Florida
PRS Account University of Florida
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP