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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests celecoxib, an anti-inflammatory drug, to determine its effectiveness for people with obsessive-compulsive disorder (OCD) who continue to experience symptoms despite medication. Researchers aim to discover if inflammation levels in the brain and blood can predict celecoxib's effectiveness for these patients. Eligible participants must have OCD not fully controlled by current medication and be able to undergo brain scans. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that celecoxib is likely to be safe for humans?

Research shows that celecoxib, a drug that reduces inflammation, is being tested for its potential to treat obsessive-compulsive disorder (OCD). People who have taken celecoxib generally tolerate it well, though some may experience side effects such as swelling, high blood pressure, and allergic reactions. The FDA has already approved celecoxib for other uses, indicating that its safety profile is well-established. This understanding includes its side effects and how the body processes it. If side effects occur, the study permits adjusting the dose or discontinuing the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for OCD?

Celecoxib is unique for treating Obsessive-Compulsive Disorder (OCD) because it targets inflammation, which is a different approach from the typical serotonin reuptake inhibitors used for OCD. Researchers are excited because celecoxib, mainly known as a pain reliever, may help reduce OCD symptoms by addressing inflammation in the brain, offering a fresh perspective on managing the condition. This novel mechanism could provide new relief for individuals who don't respond well to current treatments.

What evidence suggests that celecoxib might be an effective treatment for OCD?

Research has shown that adding celecoxib to regular OCD medication can significantly reduce OCD symptoms. In this trial, participants will receive celecoxib as an experimental treatment. One study found that patients who took celecoxib with their usual OCD medications improved more than those who did not. Other studies have found similar results, with celecoxib enhancing the effects of common OCD treatments known as SSRIs. Overall, these findings strongly suggest that celecoxib could be a beneficial addition to current OCD treatments. ^{2 3 6 7 8}

Who Is on the Research Team?

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.

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?

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+

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.

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]

Citations

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A preliminary randomized double-blind clinical trial on the ...

The results of this study suggest that celecoxib can be an effective adjuvant agent in the management of patients with OCD; therefore, anti- ...

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Effects of Celecoxib Adjunct to Selective Serotonin ...

This study showed that adjuvant treatment with celecoxib can further improve the symptoms of OCD in individuals receiving SSRIs.

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clinicaltrials.gov

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Adjunctive Celecoxib in Childhood-onset OCD Study

The primary outcome is OCD severity (as measured by total CY-BOCS score) after 12 weeks in the celecoxib compared to placebo arm, adjusted for baseline.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165178111000540

A preliminary randomized double–blind clinical trial on the ...

The celecoxib group had significantly greater improvement over the 8-week trial. The results of this study provide statistically significant support for ...

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withpower.com/trial/phase-3-compulsive-personality-disorder-3-2021-48b9c

Celecoxib for Obsessive-Compulsive Disorder

Research shows that adding celecoxib to standard OCD treatment with fluoxetine (a common OCD medication) can significantly reduce OCD symptoms more than ...

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This study is the first randomised, placebo-controlled trial to evaluate the efficacy and safety of adjunctive non-steroidal anti-inflammatory ...

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20220215 ACE-OCD summary

The Adjunctive CElecoxib in childhood-onset. OCD (ACE-OCD) study will be the first to assess the efficacy and safety of adjunctive anti- inflammatory therapy in ...

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Treatment-resistant OCD - Stanford Medicine

A preliminary randomized double–blind clinical trial on the efficacy of celecoxib as an adjunct in the treatment of obsessive–compulsive ...