Neuroinflammation in Patients With OCD

NCT04786548 | Suspended Phase 2 FDA Drug

• 1 other identifier: 8115
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; OCD; Neuroinflammation; Nonsteroidal anti-inflammatory drug; Celecoxib

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale

  The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a clinician-administered interview that measures the presence and severity of symptoms of Obsessive-Compulsive Disorder. It consists of 10 questions with scores ranging from 0 to 4, with a possible score ranging from 0 to 40. The primary measure of clinical improvement in this study is the Week 8 YBOCS score. In statistical models, we will co-vary for the Week 0 YBOCS score to account for baseline symptoms severity, but the Week 8 value is the primary outcome.

  Week 8

Secondary Outcomes (9)

• TSPO Volume of Distribution assessed by PET imaging with [11C]ER-176

  Baseline

• MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel

  Baseline

• MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel

  Week 8

• PGE2

  Baseline

• PGE2

  Week 8

Study Arms (1)

Celecoxib Treatment

EXPERIMENTAL

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

Drug: Celecoxib

Interventions

Celecoxib DRUG

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.

Also known as: Celebrex

Celecoxib Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Neuroinflammatory Diseases

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey Miller, M.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)