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Last Updated: April 14, 2025

CLINICAL TRIALS PROFILE FOR SERZONE


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All Clinical Trials for SERZONE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00015210 ↗ Nefazodone in the Treatment of Cocaine Dependence and Depression - 4 Completed Boston University Phase 2 1997-02-01 The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.
NCT00015210 ↗ Nefazodone in the Treatment of Cocaine Dependence and Depression - 4 Completed Boston Medical Center Phase 2 1997-02-01 The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for SERZONE

Condition Name

110-0.100.10.20.30.40.50.60.70.80.911.1Cocaine-Related DisordersSubstance-Related Disorders[disabled in preview]
Condition Name for SERZONE
Intervention Trials
Cocaine-Related Disorders 1
Substance-Related Disorders 1
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Condition MeSH

1110-0.100.10.20.30.40.50.60.70.80.911.1Cocaine-Related DisordersSubstance-Related DisordersDisease[disabled in preview]
Condition MeSH for SERZONE
Intervention Trials
Cocaine-Related Disorders 1
Substance-Related Disorders 1
Disease 1
[disabled in preview] 0
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Clinical Trial Locations for SERZONE

Trials by Country

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Trials by Country for SERZONE
Location Trials
United States 1
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Trials by US State

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Trials by US State for SERZONE
Location Trials
Massachusetts 1
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Clinical Trial Progress for SERZONE

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 2[disabled in preview]
Clinical Trial Phase for SERZONE
Clinical Trial Phase Trials
Phase 2 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Completed[disabled in preview]
Clinical Trial Status for SERZONE
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for SERZONE

Sponsor Name

trials000001111111Boston UniversityBoston Medical Center[disabled in preview]
Sponsor Name for SERZONE
Sponsor Trials
Boston University 1
Boston Medical Center 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Other[disabled in preview]
Sponsor Type for SERZONE
Sponsor Trials
Other 2
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Clinical Trials, Market Analysis, and Projections for Nefazodone (Serzone)

Introduction

Nefazodone, marketed under the brand name Serzone, is an antidepressant that has been used to treat major depressive disorder (MDD) and other related conditions. Here, we will delve into the current status of clinical trials, market analysis, and future projections for this drug.

Mechanism of Action and Clinical Efficacy

Nefazodone enhances serotonin (5-HT) synaptic transmission by acting as an antagonist at 5-HT2 receptors and by inhibiting the reuptake of 5-HT. This dual mechanism may also enhance 5-HT1A-mediated transmission. Additionally, nefazodone weakly inhibits the reuptake of norepinephrine, making it pharmacologically distinct from other antidepressants[4].

Clinical Trials Overview

Nefazodone has been extensively studied in clinical trials. More than 2000 patients have received nefazodone in these trials, which have shown that it is as effective as imipramine for the treatment of major depression. These trials also highlighted its benefits in patients with depression-related anxiety and sleep disturbances[4].

Adverse Drug Reactions (ADRs)

Commonly reported ADRs include asthenia, somnolence, dry mouth, nausea, constipation, dizziness, lightheadedness, confusion, abnormal vision, and blurred vision. Notably, the incidence of sexual-dysfunction ADRs may be lower compared to other antidepressants[4].

Market Analysis

Current Market Status

Nefazodone was approved by the FDA in the late 1990s but has seen a decline in usage due to the emergence of newer antidepressants with different mechanisms of action. Despite this, it remains an option for patients who do not respond well to other treatments.

Market Trends

The antidepressant market is highly competitive and is expected to grow significantly by 2034, driven by increasing disease awareness and the emergence of new products in the pipeline. However, nefazodone is not among the new drugs being heavily promoted or developed in recent years. Instead, newer drugs like Zuranolone, Seltorexant, and REL-1017 are gaining attention for their innovative mechanisms of action and potential for improved efficacy and safety[3].

Market Projections

Given the current landscape, nefazodone is unlikely to see significant market growth. Here are some key points:

Declining Usage

As newer antidepressants with more favorable side effect profiles and potentially greater efficacy enter the market, the use of nefazodone is expected to decline further.

Niche Market

Nefazodone may still find a niche in treating patients who have not responded to other antidepressants or who have specific side effect profiles that make other drugs less tolerable.

Generic Availability

Since nefazodone is no longer under patent, generic versions are available, which can make it more accessible but also reduces its market value.

Competitive Landscape

The antidepressant market is dominated by newer drugs with advanced mechanisms of action:

  • Zuranolone: A selective positive allosteric modulator of GABAA receptors, currently in Phase III clinical development[3].
  • Seltorexant: A selective orexin-2 receptor antagonist, being studied as an adjunctive treatment for MDD and insomnia[3].
  • REL-1017: In late-stage development for MDD, being tested in Phase III trials for both adjunctive and monotherapy[3].

These drugs are expected to capture a significant share of the market due to their innovative approaches and potential for better outcomes.

Conclusion

Nefazodone, while still an option for treating major depressive disorder, is not expected to see significant growth in the market. The emergence of newer, more advanced antidepressants will likely continue to shift the market landscape away from older drugs like nefazodone.

Key Takeaways

  • Nefazodone enhances serotonin transmission and weakly inhibits norepinephrine reuptake.
  • It has been shown to be effective in clinical trials but has a range of adverse drug reactions.
  • The antidepressant market is growing, but nefazodone is not among the new drugs driving this growth.
  • Newer drugs with innovative mechanisms are expected to dominate the market.
  • Nefazodone may still be used in niche cases where other treatments fail.

FAQs

What is the mechanism of action of nefazodone?

Nefazodone acts as an antagonist at 5-HT2 receptors and inhibits the reuptake of serotonin, also weakly inhibiting the reuptake of norepinephrine[4].

What are the common adverse drug reactions associated with nefazodone?

Common ADRs include asthenia, somnolence, dry mouth, nausea, constipation, dizziness, and blurred vision[4].

Is nefazodone still widely used in the treatment of major depressive disorder?

No, its usage has declined with the emergence of newer antidepressants. However, it may still be used in specific cases where other treatments are not effective.

What are some of the newer antidepressants that are gaining attention?

Drugs like Zuranolone, Seltorexant, and REL-1017 are being developed and tested for their potential in treating MDD with improved efficacy and safety[3].

Why is the market for nefazodone expected to decline?

The market is expected to decline due to the availability of newer drugs with more favorable side effect profiles and potentially greater efficacy[3].

Sources

  1. Update on Xevinapant Program - EMD Serono
  2. Sertraline: Uses, Interactions, Mechanism of Action - DrugBank Online
  3. Major Depressive Disorder Market to Register Immense Growth by 2034 - PR Newswire
  4. Nefazodone: a new antidepressant - PubMed
  5. Drug Utilization Review Board - Oklahoma.gov

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