Clinical trial

A Precision Medicine Approach to OCD Treatment: Targeting Neuroinflammation

Name

8115

Description

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.

Trial arms

Trial start

2021-04-01

Estimated PCD

2024-04-01

Trial end

2024-04-01

Status

Recruiting

Phase

Early phase I

Treatment

Celecoxib

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.

Arms:

Celecoxib Treatment

Other names:

Celebrex

Size

Primary endpoint

Yale-Brown Obsessive Compulsive Scale

Week 8

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 21, 'type': 'ESTIMATED'}}

Updated at

2023-12-19

1 organization

1 drug

1 indication

Organization

New York State Psychiatric Institute

Drug

Celecoxib

Indication

Obsessive-Compulsive Disorder