CLINICAL TRIAL

Celecoxib for Obsessive-Compulsive Disorder

Recruiting · 18 - 65 · All Sexes · New York, NY

This study is evaluating whether inflammation may be a factor in obsessive compulsive disorder.

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About the trial for Obsessive-Compulsive Disorder

Eligible Conditions
Compulsive Personality Disorder · Obsessive-Compulsive Disorder

Treatment Groups

This trial involves 2 different treatments. Celecoxib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Celecoxib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
FDA approved

Side Effect Profile for Initial Dose Celecoxib 400 mg

Initial Dose Celecoxib 400 mg
Show all side effects
5%
Beta 2 microglobulin increased
3%
Blood bilirubin increased
3%
Beta-N-acetyl-D-glucosaminidase increased
2%
Eczema
1%
Blood urine present
1%
Urobilin urine present
1%
Hypoaesthesia facial
1%
Post procedural haemorrhage
1%
Presyncope
1%
Somnolence
1%
Blood phosphorus decreased
1%
Blood creatine phosphokinase increased
1%
White blood cell count increased
1%
Rash
0%
Blood phosphorus increased
0%
Protein urine present
0%
Blood urea increased
0%
Adenocarcinoma of the cervix
Beta 2 microglobulin increased
5%
Blood bilirubin increased
3%
Beta-N-acetyl-D-glucosaminidase increased
3%
Eczema
2%
Blood urine present
1%
Urobilin urine present
1%
Hypoaesthesia facial
1%
Post procedural haemorrhage
1%
Presyncope
1%
Somnolence
1%
Blood phosphorus decreased
1%
Blood creatine phosphokinase increased
1%
White blood cell count increased
1%
Rash
1%
Blood phosphorus increased
0%
Protein urine present
0%
Blood urea increased
0%
Adenocarcinoma of the cervix
0%
This histogram enumerates side effects from a completed 2010 Phase 2 trial (NCT01062113) in the Initial Dose Celecoxib 400 mg ARM group. Side effects include: Beta 2 microglobulin increased with 5%, Blood bilirubin increased with 3%, Beta-N-acetyl-D-glucosaminidase increased with 3%, Eczema with 2%, Blood urine present with 1%.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 8
Screening: ~3 weeks
Treatment: Varies
Reporting: Week 8
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 8.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Celecoxib will improve 1 primary outcome and 5 secondary outcomes in patients with Obsessive-Compulsive Disorder. Measurement will happen over the course of Week 8.

CRP
WEEK 8
C-reactive protein levels will be measured in serum.
WEEK 8
PGE2
WEEK 8
prostaglandin E2 levels will be measured in serum.
WEEK 8
TSPO Volume of Distribution assessed by PET imaging with [11C]ER-176
BASELINE
We will perform PET imaging with the [11C]ER-176 radiotracer to quantify TSPO binding, a marker of neuroinflammation, quantified as the outcome measure Volume of Distribution (VT).
BASELINE
MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel
WEEK 8
This assay from Millipore Sigma simultaneously quantifies 41 cytokine and chemokine biomarkers from serum.
WEEK 8
PGF2-alpha
WEEK 8
Prostaglandin F2-alpha levels will be measured in serum.
WEEK 8
Yale-Brown Obsessive Compulsive Scale
WEEK 8
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

Who is running the study

Principal Investigator
J. M.
Prof. Jeffrey Miller, Associate Professor of Clinical Psychiatry
New York State Psychiatric Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can obsessive-compulsive disorder be cured?

Recent findings show evidence of symptom reduction after prolonged intensive treatment, and, consequently, a more hopeful outlook for the treatment of OCD. However, more research is needed to provide further evidence concerning the possibility of lasting remission due to sustained improvement.

Anonymous Patient Answer

How many people get obsessive-compulsive disorder a year in the United States?

It is estimated that 2.5 per 1,000 live one will get OCD in their lifetime. There are an estimated 20,000 individuals that have OCD at any given moment in time, and 2,500 of those are newly diagnosed in the year. Furthermore, around 10,000 are currently experiencing the symptoms of an acute episode.

Anonymous Patient Answer

What are common treatments for obsessive-compulsive disorder?

A variety of different treatments are prescribed for OCD. Most treatments are directed toward a subset of the condition in varying degrees of severity. Behavioral treatments are often used to supplement medication and to help patients regain their personal and social functioning. Cognitive behavioral therapy is frequently used as a monotherapy or adjunct and is an excellent candidate for further investigation.

Anonymous Patient Answer

What causes obsessive-compulsive disorder?

Unlike bipolar disorder and major depressive disorder, OCD does not appear to be triggered by psychosis or any 'triggers' in the environment. It is likely that the condition is driven by epigenetic changes in the development of glutamate circuits responsible for emotional learning or reinforcement.

Anonymous Patient Answer

What are the signs of obsessive-compulsive disorder?

Behavioural changes such as poor concentration, poor concentration when reading, and poor planning may be early signs of OCD. These can arise as a result of pre-existing psychiatric symptoms, however in an OED diagnosis attention must be paid to early behavioural changes. A history of obsessions and compulsive behaviours are essential. In an OED diagnosis, behavioural changes arising from the OC do not constitute OCD signs.

Anonymous Patient Answer

What is obsessive-compulsive disorder?

There is an increasing volume of research in OCD, a disorder characterized by obsessions and compulsions. These conditions often appear in children, adolescents, and in early adulthood. OCD is characterized by persistent and extreme anxiety, obsessions, rituals (such as handwashing), excessive thoughts about the consequences of these rituals, and repetitive attempts to decrease the anxiety induced by obsessions related to the rituals. In the first two years of life OCD is characterized by excessive anxiety and irritability during crying and crying spells. While OCD may occur in children, adolescents and adults, children are more vulnerable to the clinical and social consequences of this disorder.

Anonymous Patient Answer

Have there been any new discoveries for treating obsessive-compulsive disorder?

New treatments are entering the clinical arena for OCD, including naltrexone, a D2 blocking agent, as well as repetitive transcranial magnetic stimulation. However, no evidence exists that it is possible to eradicate OC symptoms with any of these treatments.

Anonymous Patient Answer

What are the latest developments in celecoxib for therapeutic use?

The current paradigm of the role of celecoxib is mainly based on its purported anti-inflammatory and analgesic effects. However, current knowledge suggests that celecoxib modifies other inflammatory pathways that may have positive and negative consequences for disease and prognosis.

Anonymous Patient Answer

How does celecoxib work?

The drug seems to work by inhibiting COX-2 which is thought to be related to the pathogenesis of OCD and BZD-dependent OCD symptoms such as compulsive behavior, intrusive thoughts or images and sensory overload. It is possible that celecoxib could be useful for both BzD and OCD. ClinicalTrials.gov number: NCT00494531.

Anonymous Patient Answer

What is celecoxib?

(a) Celecoxib is available to some extent to the public. (b) Compared with celecoxib from the public domain, the products with higher levels of purity, which may be more efficacious, are also more expensive. (c) For those on public subsidies, the cost of celecoxib may be less, but a broader population of individuals is at higher risk when prescribing to others. (d) If the cost of the product is the determinant of its use, then it may be more cost-effective for some to buy it from the public domain (though not in India or Australia) than for the public to use a cheaper, albeit equally effective, product from another source.

Anonymous Patient Answer

What is the average age someone gets obsessive-compulsive disorder?

Findings from a recent study adds an important piece of information that is sorely needed by clinicians and researchers. Obsessive-compulsive disorder continues to be diagnosed in a majority of American adults across all ages. The average age at diagnosis is 33.6 years and worsens markedly over time. While earlier onset cases exist, they generally arise outside of a clinical sample. While exact reasons remain to be fully elucidated, it is not a rare occurrence to see people begin to develop symptoms during their teen years, 20 to 30 years after the initial onset. The majority of cases, in this large national sample, occur by the early adulthood, 40 to 50 years after onset. It has long been known that obsessive-compulsive tendencies are transmitted to offspring.

Anonymous Patient Answer

What does celecoxib usually treat?

Since many patients do not benefit from conventional treatment, other treatments may be recommended. However, because of the high cost of various drugs and concerns regarding adverse effects, such patients are usually not taken as far as possible beyond conventional therapy for symptom relief. Further studies are needed using placebo-controlled trials for identification of effective and safe medications for many people with Tourette's syndrome.

Anonymous Patient Answer
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