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Completed

NCT Number: NCT00057603

Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

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).

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Key information

Age range

23 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Brain Stimulation

Procedure

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

Primary outcomes

  1. Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey

    Time frame: Measured pre- and post-intervention

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Pilot Study of DBS for Treatment-Refractory OCD

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Apr 7, 2003
Registry last updated
Nov 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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