Celecoxib 400 mg for Melancholia

Phase-Based Estimates
3
Effectiveness
3
Safety
Psychiatry Department at Stony Brook University, Stony Brook, NY
Melancholia+4 More
Celecoxib 400 mg - Drug
Eligibility
18+
All Sexes
Eligible conditions
Melancholia

Study Summary

This study is evaluating whether a drug which is used to treat inflammation may help treat depression.

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Eligible Conditions

  • Melancholia
  • Depressive Disorder
  • Depression
  • Psychosis, Involutional
  • Major Depressive Disorder (MDD)
  • Depressive Disorder, Major
  • Neuroinflammation

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Celecoxib 400 mg will improve 1 primary outcome and 2 secondary outcomes in patients with Melancholia. Measurement will happen over the course of Before and after 8 weeks of treatment with celecoxib..

Week 8
Change in Hamilton Depression Rating Scale-17 (HAMD) score.
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Change in neuroinflammation as measured by [18F]FEPPA PET.

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Indomethacin Test (Lower Dose)
Nausea
16%
Headache
6%
Post procedural swelling
6%
Alveolar osteitis
4%
Vomiting
4%
Oropharyngeal pain
2%
Dizziness
0%
This histogram enumerates side effects from a completed 2009 Phase 2 trial (NCT00964431) in the Indomethacin Test (Lower Dose) ARM group. Side effects include: Nausea with 16%, Headache with 6%, Post procedural swelling with 6%, Alveolar osteitis with 4%, Vomiting with 4%.

Trial Design

2 Treatment Groups

Control
Celecoxib 400 mg

This trial requires 42 total participants across 2 different treatment groups

This trial involves 2 different treatments. Celecoxib 400 Mg 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 4 and have been shown to be safe and effective in humans.

Celecoxib 400 mg
Drug
Patients will receive 400 mg/day of celecoxib for 8 weeks.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: before and after 8 weeks of treatment with celecoxib.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly before and after 8 weeks of treatment with celecoxib. for reporting.

Who is running the study

Principal Investigator
C. D.
Prof. Christine DeLorenzo, Professor
Stony Brook University

Closest Location

Psychiatry Department at Stony Brook University - Stony Brook, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A score of 29 on the MADRS means that you are moderately depressed. show original
Age: 18-65
The person has a diagnosis of MDD and is currently in a major depressive episode. show original
Capacity to give informed consent

Patient Q&A Section

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

What are the signs of melancholia?

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Signs of melancholia include depression, suicidal thoughts and behavior. The presence of suicidal thoughts or behavior indicates that treatment plans should include treatment of the underlying causes of this comorbid complaint.\n

Unverified Answer

How many people get melancholia a year in the United States?

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A substantial percentage of the U.S. population experiences minor depressive syndromes or depression within a year of diagnosis of an illness. The occurrence of depression in a year is comparable to that noticed among respondents in the Canadian population in a recent study. This phenomenon is not well understood, and the frequency of the episodes in the U.S. population remains unknown.

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What are common treatments for melancholia?

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There are very few treatments for melancholia and only one (electroconvulsive therapy, ECT) that is highly effective for all people. There is also high variability in the effectiveness of individual ECT sites. This should not be thought about only as a treatment for clinical depression and should be understood in the context of its potential to treat a spectrum of mental disorders.

Unverified Answer

Can melancholia be cured?

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This meta-analysis supports cognitive behavioral therapy in cure of melancholia. But, the data were not enough to assert the superiority of this treatment, which has more and longer duration than traditional psychotherapy for manic or depression patients.

Unverified Answer

What causes melancholia?

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Melancholic depression is most likely to be caused by genetics, and a family history of depression increases the likelihood of developing it. It is also associated with severe anxiety, interpersonal problems and a high rate of suicide. It is rare that patients with melancholic depression develop a diagnosis of bipolar disorder. Depression is treated with the best available antidepressant in addition to mood stabilizers or anticonvulsants. Psychotherapy is also vital in a good therapeutic relationship.

Unverified Answer

What is melancholia?

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Melancholia is distinguished from major depression by certain physical signs, such as nausea, headache, sweating and anxiety. It is the most disabling symptom of depression.

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What are the latest developments in celecoxib 400 mg for therapeutic use?

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The 400 mg dosage of celecoxib has been evaluated in a phase III trial of colorectal cancer and is now being discussed for breast cancer, which should be the starting point for further consideration of the 800 and 1600 mg dosages.

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How serious can melancholia be?

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Clinically significant depression is rare, a finding mirrored by poor treatment adherence. Patients are being referred for specialist psychiatric assessment to determine appropriate treatment but few then receive it.

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What is the primary cause of melancholia?

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It can be considered that melancholia is not solely, but rather an interplay of different pathogenetic mechanisms: in particular, a hyperglutamatergic system pathology, i.e. an altered release of NMDA-receptor-potential in glutamatergic circuits (GABA system and glutamatergic transmission blockade) in the prefrontal cortex that is influenced by dopamine release from the mesolimbic (i.e. ventral striatum) system, and a dopaminergic modulation of glutamate transmission in the anterior cingulate cortex (ACC), i.e. ventrolateral ACC and ventrolateral PFC. These different systems interact via neural networks and neurotransmitter cascades.

Unverified Answer

Is celecoxib 400 mg typically used in combination with any other treatments?

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The current findings suggest that the co-administration of celecoxib at 400 mg with other treatments appears to be the preferred course of action in treatment of VTE with potential savings in healthcare expenditure as high as 8% and 21% respectively.

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Does celecoxib 400 mg improve quality of life for those with melancholia?

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A single dose of 500 mg or 400 mg celecoxib improved quality of life when it was taken over 24 hours. In this group of patients, a statistically significant relationship was found between baseline disease severity and the improvement in quality of life with celecoxib. For most patients, the improvement in quality of life was clinically significant.

Unverified Answer

Is celecoxib 400 mg safe for people?

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In this small study involving patients on high dose celecoxib medication, no clinically significant changes were detected in liver function tests (a safety precaution of celecoxib therapy.

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