Neuroinflammation in Patients With OCD

New York State Psychiatric Institute

Status and phase: Suspended; Phase 2

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT04786548

8115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Celecoxib Treatment

Experimental group

Description:

Patients will receive standardized pharmacotherapy with celecoxib 100mg twice daily for the first week, and will then, if well-tolerated, will be increased to 200mg twice daily for the next seven weeks. Visits with the study psychiatrist will occur weekly for the first four weeks, and biweekly thereafter until week 8, which will be conducted remotely in general, although they may be conducted in-person as clinically warranted and may be conducted in person on the days of other in-person visits. If individuals experience significant side-effects from a given dose, the treating physician may lower the medication dose according to clinical judgment; if side-effects are intolerable, we will discontinue the research procedures and advance to open clinical treatment

Treatment:

Drug: Celecoxib