Clinical trial NCT04786548: Neuroinflammation in Patients With OCD
Official title: A Precision Medicine Approach to OCD Treatment: Targeting Neuroinflammation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
OCD
Neuroinflammation
Nonsteroidal anti-inflammatory drug
Celecoxib
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to examine whether measurements of inflammation from brain scanning and blood tests can predict how much benefit patients with obsessive-compulsive disorder (OCD) will have from treatment with an anti-inflammatory medication, celecoxib, when adding to ongoing medication-based treatment for OCD.

Detailed description: Existing evidence-based treatments for adults with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy and first-line medication-based treatment, do not fully resolve symptoms for a majority of patients. This study proposes to test a new treatment strategy for OCD, examining inflammation as one factor that may contribute to the development of OCD and that may be targeted with medication-based treatment. Recent findings using both brain imaging and analyses from blood samples suggest that some individuals with OCD have increased levels of inflammation in the brain, which may have negative effects on brain function, contributing to symptoms of OCD. Moreover, early clinical studies suggest that some medications with anti-inflammatory properties may be beneficial in treating OCD symptoms. An important and untested question is whether the degree of inflammation assessed using these biological tools can predict how much benefit individuals with OCD will derive from treatment with an anti-inflammatory medication. The investigators will measure inflammation in the brain using PET imaging and measures of inflammation in the body using blood tests in adults with OCD. Patients will then undergo 8 weeks of treatment with an anti-inflammatory medication with some evidence of clinical effectiveness in OCD, celecoxib. The investigators predict that OCD patients with greater evidence of inflammation at baseline, assessed by brain imaging and blood tests, will derive the greatest benefit from anti-inflammatory treatment. In addition, the investigators will compare these inflammatory markers with data from a group of healthy volunteers (collected as part of another protocol, IRB #6786), to extend earlier work finding elevated inflammatory markers in adult OCD. Finally, the investigators will examine whether celecoxib treatment in OCD patients results in reductions in measures of inflammation measured from blood samples and whether the degree of anti-inflammatory effect observed biologically is related to improvement in OCD symptoms. The ultimate goal of this line of research is to pave the way for more individually-tailored, effective treatments for adult OCD based on improved understandings of pathological targets, and to validate an anti-inflammatory approach to the treatment of OCD in individuals with evidence of inflammation.

Eligibility criteria: Inclusion Criteria:

* 18 to 55 years old
* Principal diagnosis of Obsessive-Compulsive Disorder (OCD)
* Ongoing OCD symptoms despite current treatment with psychiatric medication
* Capacity to provide informed consent

Exclusion Criteria:

* Psychiatric comorbidities that would increase risk of participation or impact research measures (e.g., suicidality)
* Medical or neurological conditions that would increase risk of participation or impact research measures
* Contraindications to an MRI or PET scan (e.g., metal implants)
* Current use of medications that may interact with study drug or impact research measures (e.g., antipsychotics, corticosteroids, immunosuppressant medications, or daily non-steroidal anti-inflammatory medications)
* Starting a new evidence-based therapy for OCD (e.g., exposure with response prevention) 4 weeks prior to study enrollment

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale
timeFrame: Week 8
Secondary outcomes:
measure: TSPO Volume of Distribution assessed by PET imaging with [11C]ER-176
timeFrame: Baseline
measure: MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel
timeFrame: Baseline
measure: MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel
timeFrame: Week 8
measure: PGE2
timeFrame: Baseline
measure: PGE2
timeFrame: Week 8
measure: PGF2-alpha
timeFrame: Week 0
measure: PGF2-alpha
timeFrame: Week 8
measure: CRP
timeFrame: Week 0
measure: CRP
timeFrame: Week 8
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Jeffrey Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: