Status:
ACTIVE_NOT_RECRUITING
Phase II Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
University of Pittsburgh
Brown University
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This research study is for participants that have been diagnosed with intractable Obsessive -compulsive disorder (OCD). OCD is a persistent and oftentimes disabling disorder marked by unwanted and dis...
Detailed Description
ENROLLMENT: A subject is considered enrolled upon signing informed consent and deemed eligible to be screened by the investigator. The informed consent process may include discussions with the patient...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study specific procedures being performed
- Male or female between ages 21 and 70;
- At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
- A primary diagnosis of OCD with Y-BOCS minimum score of 28;
- Failed an adequate trial of at least three of the following SSRIs: Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine;
- Failed or could not tolerate an adequate trial of clomipramine;
- Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole;
- Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;
- Stable psychotropic medical regimen for the month preceding surgery
Exclusion
- Inability or refusal to give informed consent.
- Lifetime diagnosis of psychotic disorders such as schizophrenia;
- Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
- Deemed at high risk of suicidal behavior or impulsivity, per clinical opinion assessments.
- Any Neurological/Medical condition that makes the subject, in the opinion of the surgeon, a poor candidate.
- Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months.
- Need for Diathermy
- Contraindications to MRI
- Contraindications to MEG
- Subject is determined to not be appropriate for this study based on the medical expertise of the investigator.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04806516
Start Date
July 1 2021
End Date
July 30 2026
Last Update
August 18 2025
Active Locations (3)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
2
Brown University
Providence, Rhode Island, United States, 02912
3
Baylor College of Medicine
Houston, Texas, United States, 77030