21 Participants Needed

Celecoxib for Obsessive-Compulsive Disorder

GM
GR
Overseen ByGabriella Restifo-Bernstein, BS
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: New York State Psychiatric Institute
Must be taking: Psychiatric medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if adding the anti-inflammatory drug celecoxib to current treatments helps adults with OCD who still have symptoms. It focuses on patients with high brain inflammation, measured by scans and blood tests, to see if they improve more with this added medication. Celecoxib has been tested as an additional therapy in schizophrenia, showing significant improvement in symptoms, particularly in patients with recent-onset schizophrenia.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that might interact with the study drug, such as antipsychotics, corticosteroids, immunosuppressants, or daily non-steroidal anti-inflammatory medications. However, you can continue your current psychiatric medication for OCD.

Is celecoxib safe for use in humans?

Celecoxib is generally considered safe for humans, with a better gastrointestinal safety profile compared to other non-steroidal anti-inflammatory drugs (NSAIDs). However, it should be used with caution in people with cardiovascular risks, allergies to sulfonamides, or other NSAID allergies.12345

How does the drug celecoxib differ from other treatments for obsessive-compulsive disorder?

Celecoxib is unique because it is primarily a nonsteroidal anti-inflammatory drug (NSAID) that selectively inhibits cyclooxygenase-2 (COX-2), which is different from typical OCD treatments that often involve antidepressants or cognitive-behavioral therapy. Its potential use for OCD is novel and may involve mechanisms beyond its anti-inflammatory effects, such as inhibiting acetylcholinesterase, which could influence brain chemistry related to OCD.678910

What data supports the effectiveness of the drug celecoxib for treating Obsessive-Compulsive Disorder (OCD)?

Research shows that adding celecoxib to standard OCD treatment with fluoxetine (a common OCD medication) can significantly reduce OCD symptoms more than fluoxetine alone. This suggests that celecoxib, which reduces inflammation, may help improve OCD treatment outcomes.1231112

Who Is on the Research Team?

Jeffrey M. Miller, MD | Columbia ...

Jeffrey Miller, MD

Principal Investigator

New York State Psychiatric Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 with Obsessive-Compulsive Disorder (OCD) who still have symptoms despite current medication. Participants must be able to consent and not have medical conditions or metal implants that could interfere with brain scans, nor take medications like antipsychotics or steroids that affect the study drug.

Inclusion Criteria

My main diagnosis is Obsessive-Compulsive Disorder.
My OCD symptoms persist despite taking psychiatric medication.
I understand and can agree to the study's procedures and risks.

Exclusion Criteria

You cannot have an MRI or PET scan because you have metal implants.
Medical or neurological conditions that would increase risk of participation or impact research measures
I am not taking any medications that could affect the study drug.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive celecoxib 100mg twice daily for the first week, then 200mg twice daily for the next seven weeks if well-tolerated

8 weeks
Weekly visits for the first 4 weeks, biweekly thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Celecoxib
Trial Overview The study tests if celecoxib, an anti-inflammatory medicine, can help people with OCD when added to their existing treatment. It involves measuring inflammation in the brain and blood to see if these can predict the benefit from celecoxib.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Celecoxib TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials
481
Recruited
154,000+

Published Research Related to This Trial

Celecoxib is a selective COX-2 inhibitor that offers similar pain relief as traditional NSAIDs but has a safer gastrointestinal profile, making it a preferable option for patients at risk of GI complications.
Despite its GI safety, celecoxib carries similar risks of other adverse effects as NSAIDs, and caution is advised for certain populations, including the elderly and those with cardiovascular issues, as it does not provide antithrombotic benefits.
[Safety of celecoxib administration].Babić-Naglić, D.[2017]
Celecoxib is associated with a slightly increased risk of certain adverse events, such as edema, hypertension, angioedema, and allergic reactions compared to placebo, but these risks are relatively small.
In contrast, celecoxib shows a lower risk of gastrointestinal issues like hemorrhage and ulceration compared to non-selective NSAIDs, suggesting it may be a safer option for patients concerned about GI side effects.
Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials.Essex, MN., Zhang, RY., Berger, MF., et al.[2022]
Celecoxib is an effective treatment for various types of arthritis and pain management, offering improved gastrointestinal tolerability compared to nonselective NSAIDs, making it a safer option for patients at risk of GI issues.
While there is some inconsistency regarding its cardiovascular risk, any potential increase is likely small and comparable to that of nonselective NSAIDs, suggesting celecoxib is a reasonable choice for patients with low cardiovascular risk who need NSAID therapy.
Celecoxib: a review of its use in the management of arthritis and acute pain.Frampton, JE., Keating, GM.[2021]

Citations

Celecoxib potentiates the antianxiety and anticompulsive-like activity of fluoxetine against chronic unpredictable mild stress in experimental animals. [2022]
A preliminary randomized double-blind clinical trial on the efficacy of celecoxib as an adjunct in the treatment of obsessive-compulsive disorder. [2015]
Methodological issues in the design of clinical studies of new drugs for the treatment of obsessive compulsive disorder. [2020]
Effects of Celecoxib Adjunct to Selective Serotonin Reuptake Inhibitors on Obsessive-Compulsive Disorder. [2022]
Celecoxib versus placebo as an adjunct to treatment-as-usual in children and youth with obsessive-compulsive disorder: protocol for a single-site randomised quadruple-blind phase II study. [2022]
[Safety of celecoxib administration]. [2017]
Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. [2022]
Celecoxib: a review of its use in the management of arthritis and acute pain. [2021]
Stability of celecoxib oral suspension. [2021]
Celecoxib is an inhibitor of enzyme acetylcholinesterase. [2017]
11.United Statespubmed.ncbi.nlm.nih.gov
COX 2-selective NSAIDs: biology, promises, and concerns. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
The Importance of Drug Concentration at the Site of Action: Celecoxib and Colon Polyp Prevention as a Case Study. [2022]
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