Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT00057603
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
23 Years
Maximum Age:
65 Years
Study:
NCT00057603
Study Brief:
Protocol Section:
NCT00057603