Celecoxib for Obsessive-Compulsive Disorder

Overseen By Gabriella Restifo-Bernstein, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: New York State Psychiatric Institute

Must be taking: Psychiatric medications

Must not be taking: Antipsychotics, Corticosteroids, Immunosuppressants, NSAIDs

Disqualifiers: Suicidality, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

21 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{8 9 10 11 12}

Research Team

Jeffrey Miller, MD

Principal Investigator

New York State Psychiatric Institute

Eligibility Criteria

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

I am between 18 and 55 years old.

My main diagnosis is Obsessive-Compulsive Disorder.

My OCD symptoms persist despite taking psychiatric medication.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Celecoxib Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Celecoxib: a review of its use in the management of arthritis and acute pain. Frampton, JE., Keating, GM.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Celecoxib potentiates the antianxiety and anticompulsive-like activity of fluoxetine against chronic unpredictable mild stress in experimental animals. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

A preliminary randomized double-blind clinical trial on the efficacy of celecoxib as an adjunct in the treatment of obsessive-compulsive disorder. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Methodological issues in the design of clinical studies of new drugs for the treatment of obsessive compulsive disorder. [2020]

4. Iran pubmed.ncbi.nlm.nih.gov

Effects of Celecoxib Adjunct to Selective Serotonin Reuptake Inhibitors on Obsessive-Compulsive Disorder. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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]

6. Croatia pubmed.ncbi.nlm.nih.gov

[Safety of celecoxib administration]. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Celecoxib: a review of its use in the management of arthritis and acute pain. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Stability of celecoxib oral suspension. [2021]

10. Sweden pubmed.ncbi.nlm.nih.gov

Celecoxib is an inhibitor of enzyme acetylcholinesterase. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

COX 2-selective NSAIDs: biology, promises, and concerns. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The Importance of Drug Concentration at the Site of Action: Celecoxib and Colon Polyp Prevention as a Case Study. [2022]