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New treatment option for Obsessive-Compulsive Disorder
Official title Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder
ClinicalTrials.gov ID: NCT06660225
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer are: Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)stimulation on obsessive/compulsive symptoms.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- Patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria
- Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 27
- Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment.
- Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time...
- Having failed to improve despite adequate cognitive behavioral therapy, as evaluated by the study psychiatrist
You likely can't join if
- Diagnosis of severe major depression disorder (MDD) with psychotic features.
- Significant suicidal risk [Hamilton Depression scale item 3 (suicide)\>2].
- Comorbidity with any primary Psychotic Disorder, Post-Traumatic Stress Disorder (PTSD), or Eating Disorder.
- History of substance or alcohol dependence or abuse in the preceding 12 months.
- Significant cognitive decline, measured by Mini-Mental State Examination (MMSE \<26) and Montreal Cognitive Assessment (MoCA; \<24).
- Any other current clinical significant neurological disorder or medical illness affecting brain function, other than a tic disorder.
See the full eligibility criteria
- Patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria
- Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 27
- Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment.
- Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time period.
- Having failed to improve despite adequate cognitive behavioral therapy, as evaluated by the study psychiatrist
- Patients between 22 and 75.
- Ability to understand and sign written informed consent by the patient.
- Diagnosis of severe major depression disorder (MDD) with psychotic features.
- Significant suicidal risk [Hamilton Depression scale item 3 (suicide)\>2].
- Comorbidity with any primary Psychotic Disorder, Post-Traumatic Stress Disorder (PTSD), or Eating Disorder.
- History of substance or alcohol dependence or abuse in the preceding 12 months.
- Significant cognitive decline, measured by Mini-Mental State Examination (MMSE \<26) and Montreal Cognitive Assessment (MoCA; \<24).
- Any other current clinical significant neurological disorder or medical illness affecting brain function, other than a tic disorder.
- Any clinically significant abnormality on preoperative MRI that would affect the safety of the surgical procedure in the opinion of the study neurosurgeon.
- Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery.
- Pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.