One Month Blinded Discontinuation Period for Obsessive-Compulsive Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obsessive-Compulsive Disorder+2 More
One Month Blinded Discontinuation Period: - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for participants that have been diagnosed with intractable Obsessive-compulsive disorder (OCD) and want to develop an adaptive Deep Brain Stimulation (aDBS) system.

Eligible Conditions
  • Obsessive-Compulsive Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Month 18

Baseline to 30 days
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Rating OCD Symptom Severity
Month 18
Hypomania
Percent of subjects that display biomarkers of OCD-related distress

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

One Month Blinded Discontinuation Period
1 of 2
Summit RC+S DBS Implant for OCD
1 of 2

Experimental Treatment

5 Total Participants · 2 Treatment Groups

Primary Treatment: One Month Blinded Discontinuation Period · No Placebo Group · N/A

One Month Blinded Discontinuation Period
Other
Experimental Group · 1 Intervention: One Month Blinded Discontinuation Period: · Intervention Types: Other
Summit RC+S DBS Implant for OCD
Device
Experimental Group · 1 Intervention: Summit RC+S System with ECoG Paddles · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 18

Who is running the clinical trial?

Brown UniversityOTHER
408 Previous Clinical Trials
514,511 Total Patients Enrolled
8 Trials studying Obsessive-Compulsive Disorder
464 Patients Enrolled for Obsessive-Compulsive Disorder
University of PittsburghOTHER
1,600 Previous Clinical Trials
6,285,710 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
149 Patients Enrolled for Obsessive-Compulsive Disorder
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,250 Previous Clinical Trials
452,348 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
5,005 Patients Enrolled for Obsessive-Compulsive Disorder
Baylor College of MedicineLead Sponsor
914 Previous Clinical Trials
5,982,034 Total Patients Enrolled
12 Trials studying Obsessive-Compulsive Disorder
990 Patients Enrolled for Obsessive-Compulsive Disorder
MedtronicIndustry Sponsor
571 Previous Clinical Trials
732,643 Total Patients Enrolled
5 Trials studying Obsessive-Compulsive Disorder
72 Patients Enrolled for Obsessive-Compulsive Disorder
Carnegie Mellon UniversityOTHER
70 Previous Clinical Trials
536,448 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
17 Patients Enrolled for Obsessive-Compulsive Disorder
Wayne Goodman, MDPrincipal Investigator - Baylor College of Medicine
Baylor College of Medicine
6 Previous Clinical Trials
146 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
146 Patients Enrolled for Obsessive-Compulsive Disorder

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
alternative treatments should be considered The individual could not tolerate an adequate trial of clomipramine; alternative treatments should be considered.
paliperidone The following antipsychotics can be used to augment one or more of the aforementioned drugs: haloperidol, risperidone, quetiapine, ziprasidone, aripiprazole, paliperidone.
The patient failed an adequate trial of CBT for OCD, which is defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist.
A stable psychotropic medication regimen for the month preceding surgery is important to prevent or minimize surgical and postoperative complications.
Any race; No major medical problems A person between the ages of 21 and 70 who is of any race and who does not have any major medical problems.
is mandatory Before any study-related procedures are performed, you must sign an informed consent form.
and At least one unsuccessful trial of a serotonin reuptake inhibitor (SRI) in the current episode of OCD The individual has had OCD for at least five years and has not responded to treatment with serotonin reuptake inhibitors
The person has a primary diagnosis of OCD and their Y-BOCS score is at least 28.
and/or venlafaxine The person failed to respond adequately to treatment with at least three of the following SSRIs: Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine; and/or venlafaxine.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: November 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Baylor College of Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%