NCT00057603

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2003

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

8.5 years

First QC Date

April 4, 2003

Last Update Submit

November 8, 2011

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

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

    Measured pre- and post-intervention

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Participants receive deep brain stimulation treatment for 30 months.

Procedure: Deep Brain Stimulation

Interventions

Deep Brain StimulationPROCEDURE

Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.

Deep Brain Stimulation

Eligibility Criteria

Age23 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Related Publications (2)

  • 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.

    PMID: 22305344DERIVED

  • 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.

    PMID: 20116047DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Herbert Ward, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2003

First Posted

April 7, 2003

Study Start

January 1, 2001

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

US(1)