Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Pilot Study of DBS for Treatment-Refractory OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057603
• Other study ID #: R21MH064161
• Secondary ID: R21MH064161DATR
• Status: Completed
• Phase: N/A
• First received: April 4, 2003
• Last updated: November 8, 2011
• Start date: January 2001
• Est. completion date: July 2009

Study information

• Verified date: November 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida College of Medicine	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey		Measured pre- and post-intervention	Yes