CLINICAL TRIALS PROFILE FOR PHENELZINE SULFATE

All Clinical Trials for phenelzine sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02217709 ↗	Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2014-09-08	This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of antidepressant that works by decreasing the amount of a protein called monoamine oxidase (MAO). MAO drugs may have an anticancer effect in prostate cancer.
NCT01253642 ↗	Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel	Terminated	National Cancer Institute (NCI)	Phase 2	2010-07-12	This phase II trial studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.
NCT01253642 ↗	Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel	Terminated	The Wayne D. Kuni and Joan E. Kuni Foundation	Phase 2	2010-07-12	This phase II trial studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.
NCT01253642 ↗	Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel	Terminated	OHSU Knight Cancer Institute	Phase 2	2010-07-12	This phase II trial studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.

Clinical Trial Conditions for phenelzine sulfate

Condition Name

Condition Name for phenelzine sulfate
Intervention	Trials
Healthy	1
Hormone-Resistant Prostate Cancer	1
Metastatic Breast Cancer	1
Metastatic Prostatic Adenocarcinoma	1

Condition MeSH

Condition MeSH for phenelzine sulfate
Intervention	Trials
Prostatic Neoplasms	2
Adenocarcinoma	2
Breast Neoplasms	1

Clinical Trial Locations for phenelzine sulfate

Trials by Country

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−

Trials by Country for phenelzine sulfate
Location	Trials
United States	3
Australia	2
Netherlands	1

Trials by US State

+

−

Trials by US State for phenelzine sulfate
Location	Trials
California	1
Washington	1
Oregon	1

Clinical Trial Progress for phenelzine sulfate

Clinical Trial Phase

Clinical Trial Phase for phenelzine sulfate
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for phenelzine sulfate
Clinical Trial Phase	Trials
Terminated	2
Completed	1
Active, not recruiting	1

Clinical Trial Sponsors for phenelzine sulfate

Sponsor Name

Sponsor Name for phenelzine sulfate
Sponsor	Trials
National Cancer Institute (NCI)	2
Liverpool Cancer Therapy Centre	1
Southern Medical Day Care Centre	1

Sponsor Type

Sponsor Type for phenelzine sulfate
Sponsor	Trials
Other	6
Industry	2
NIH	2

Phenelzine Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction

Phenelzine sulfate, a non-selective and irreversible monoamine oxidase (MAO) inhibitor, has been a significant player in the treatment of depression, particularly for patients with atypical or nonendogenous depression and those with mixed anxiety and depressive symptoms. Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Efficacy and Trials

Effectiveness in Depression and Anxiety

Clinical trials have consistently shown that phenelzine sulfate is effective in relieving symptoms of depression and anxiety. A double-blind, controlled study found that a daily dose of 60 mg of phenelzine sulfate was significantly more effective than placebo in treating outpatients with depressive-anxiety states[1].

Dosage and Platelet MAO Inhibition

The efficacy of phenelzine sulfate is closely related to the degree of platelet MAO inhibition. Studies indicate that a higher dose, such as 60 mg daily, results in a median inhibition of platelet monoamine oxidase that exceeds 80%, which is associated with greater clinical improvement[1][4].

Specific Patient Populations

Phenelzine sulfate has been found to be particularly effective in patients with nonendogenous depression and phobic disorders. It is often used as a second-line treatment for patients who have failed to respond to more commonly used antidepressants[2][4].

Market Analysis

Availability and Supply Issues

Phenelzine sulfate has faced significant supply issues in recent years. In 2020, several countries, including Canada, reported shortages of the drug, categorizing it under Tier 3 shortages, which are those with the greatest impact on supply[2][5].

Global Distribution

Despite its efficacy, phenelzine sulfate is not widely available globally. It is currently available in a few countries such as Australia, Belgium, Canada, the United Kingdom, and the United States, but shortages have been reported in many of these jurisdictions[3].

Pricing and Accessibility

The drug is more highly priced than other commonly used antidepressants, which, combined with its limited global availability, makes it less accessible in low- and middle-income settings. This pricing and availability issue has been a significant concern for health authorities and the WHO[3].

Safety Profile and Monitoring

Adverse Effects and Interactions

Phenelzine sulfate is associated with potentially serious adverse effects, including the risk of pulmonary and vascular tumors, and it has a high potential for drug-drug and drug-food interactions. This necessitates careful and specialized monitoring and management, which may not be feasible in all healthcare settings[2][3].

Contraindications

The drug is contraindicated in patients with hypersensitivity to the drug or its ingredients, pheochromocytoma, congestive heart failure, severe renal impairment, liver disease, or abnormal liver function tests[2].

Market Projections

Demand and Supply Dynamics

Given the ongoing supply issues and the high demand for phenelzine sulfate, particularly in regions where it is listed as a Tier 3 shortage, the market is likely to face continued challenges in ensuring a steady supply. Health authorities and manufacturers are working to mitigate these shortages, but the future supply remains uncertain[5].

Competitive Landscape

Phenelzine sulfate competes with other antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants, which have more favorable safety profiles and are more widely available. However, phenelzine's efficacy in specific patient populations, such as those with treatment-resistant depression, maintains its relevance in the market[3].

Regulatory Considerations

The WHO has not recommended the inclusion of phenelzine sulfate in the Essential Medicines List (EML) for the treatment of treatment-resistant depression due to the uncertain evidence of benefit and the increased risk of harms. This decision may impact its market presence and accessibility in various regions[3].

Expert Insights and Statistics

Efficacy Compared to Other Antidepressants

A meta-analysis found that phenelzine had the highest odds ratio for efficacy relative to placebo among all antidepressants evaluated, with an odds ratio of 4.66 (95% credible interval 2.64 to 8.40)[3].

Clinical Monitoring

"Phenelzine requires careful monitoring and has a less favourable safety profile compared with other antidepressants," notes the WHO Expert Committee. This highlights the need for specialized healthcare facilities and professionals to manage patients on this medication[3].

Key Takeaways

• Clinical Efficacy: Phenelzine sulfate is effective in treating depression and anxiety, particularly in patients with nonendogenous depression and phobic disorders.
• Supply Issues: The drug faces significant supply shortages globally, impacting its availability and accessibility.
• Safety Profile: It has a high potential for adverse effects and drug interactions, requiring careful monitoring.
• Market Dynamics: The competitive landscape is challenging due to the availability of safer and more widely accessible antidepressants.
• Regulatory Status: Not recommended for inclusion in the WHO EML due to uncertain evidence and safety concerns.

FAQs

Q: What is phenelzine sulfate used for?

A: Phenelzine sulfate is used to treat depression, particularly in patients with atypical or nonendogenous depression and those with mixed anxiety and depressive symptoms.

Q: Why is phenelzine sulfate facing supply issues?

A: Phenelzine sulfate is facing supply issues due to manufacturing and distribution challenges, leading to shortages in several countries.

Q: What are the potential side effects of phenelzine sulfate?

A: The drug is associated with potentially serious adverse effects, including pulmonary and vascular tumors, and has a high potential for drug-drug and drug-food interactions.

Q: Is phenelzine sulfate recommended by the WHO for treatment-resistant depression?

A: No, the WHO has not recommended the inclusion of phenelzine sulfate in the Essential Medicines List for the treatment of treatment-resistant depression due to uncertain evidence and safety concerns.

Q: How does phenelzine sulfate compare to other antidepressants in terms of efficacy?

A: Phenelzine sulfate has been shown to have superior efficacy compared to other antidepressants in some studies, but it also has a less favorable safety profile.

Sources

1. A multiple-dose, controlled study of phenelzine in depression ... - PubMed
2. Communications regarding phenelzine discontinuation - Pharmac
3. Phenelzine - eEML - Electronic Essential Medicines List - Essential Meds
4. Clinical pharmacology of phenelzine - PubMed
5. NARDIL (phenelzine sulfate) Shortage - Canada.ca