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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR AMOXAPINE


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All Clinical Trials for AMOXAPINE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00000272 ↗ Early Phase II Trials for Cocaine Medication Development - 1 Completed National Institute on Drug Abuse (NIDA) Phase 2 1996-08-01 The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents. The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This
NCT00000272 ↗ Early Phase II Trials for Cocaine Medication Development - 1 Completed New York State Psychiatric Institute Phase 2 1996-08-01 The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents. The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This
NCT00000272 ↗ Early Phase II Trials for Cocaine Medication Development - 1 Completed Research Foundation for Mental Hygiene, Inc. Phase 2 1996-08-01 The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents. The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for AMOXAPINE

Condition Name

2210-0.200.20.40.60.811.21.41.61.822.2Cocaine-Related DisordersSubstance-Related DisordersSchizophrenia[disabled in preview]
Condition Name for AMOXAPINE
Intervention Trials
Cocaine-Related Disorders 2
Substance-Related Disorders 2
Schizophrenia 1
[disabled in preview] 0
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Condition MeSH

2220-0.200.20.40.60.811.21.41.61.822.2Substance-Related DisordersDiseaseCocaine-Related Disorders[disabled in preview]
Condition MeSH for AMOXAPINE
Intervention Trials
Substance-Related Disorders 2
Disease 2
Cocaine-Related Disorders 2
[disabled in preview] 0
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Clinical Trial Locations for AMOXAPINE

Trials by Country

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Trials by Country for AMOXAPINE
Location Trials
United States 3
Brazil 1
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Trials by US State

+
Trials by US State for AMOXAPINE
Location Trials
New York 2
Indiana 1
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Clinical Trial Progress for AMOXAPINE

Clinical Trial Phase

25.0%50.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 4Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for AMOXAPINE
Clinical Trial Phase Trials
Phase 4 1
Phase 2 2
Phase 1 1
[disabled in preview] 0
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Clinical Trial Status

100.0%000.511.522.533.54Completed[disabled in preview]
Clinical Trial Status for AMOXAPINE
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for AMOXAPINE

Sponsor Name

trials0112233National Institute on Drug Abuse (NIDA)New York State Psychiatric InstituteResearch Foundation for Mental Hygiene, Inc.[disabled in preview]
Sponsor Name for AMOXAPINE
Sponsor Trials
National Institute on Drug Abuse (NIDA) 3
New York State Psychiatric Institute 3
Research Foundation for Mental Hygiene, Inc. 2
[disabled in preview] 0
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Sponsor Type

63.6%27.3%9.1%001234567OtherNIHIndustry[disabled in preview]
Sponsor Type for AMOXAPINE
Sponsor Trials
Other 7
NIH 3
Industry 1
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Amoxapine: Clinical Trials, Market Analysis, and Projections

Introduction

Amoxapine is a tricyclic antidepressant with additional antipsychotic properties, used primarily for the treatment of depression, including neurotic or reactive depressive disorders, endogenous and psychotic depressions, and depression accompanied by anxiety or agitation. Here, we will delve into the clinical trials, market analysis, and projections for amoxapine.

Clinical Trials and Efficacy

Clinical Response and Onset of Action

Clinical studies have shown that amoxapine has a more rapid onset of action compared to other tricyclic antidepressants like amitriptyline and imipramine. The initial clinical effect may occur within four to seven days, and over 80% of responders experience improvement within two weeks[1].

Safety and Monitoring

Clinical trials and post-marketing surveillance highlight the importance of monitoring patients for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment or at times of dose changes. This is consistent with observations in other antidepressant drugs[1].

Comparison with Other Antidepressants

Studies sponsored by pharmaceutical companies to obtain FDA approval have shown that amoxapine, along with other antidepressants like trazodone and maprotiline, demonstrates efficacy superior to placebo. The effect sizes of these drugs are comparable to those of standard antidepressants, indicating their validity in treating depression[3].

Market Analysis

Global Antipsychotic Drugs Market

The global antipsychotic drugs market, which includes amoxapine, is projected to grow at a Compound Annual Growth Rate (CAGR) of around 2.5% over the next decade, reaching approximately $14.91 billion by 2025. This growth is driven by factors such as the increasing incidence of mental health disorders and recent technological developments in antipsychotic drugs[2][5].

Market Segmentation

The antipsychotic drugs market is segmented by application, with key areas including unipolar depression, schizophrenia, dementia, and bipolar disorders. Amoxapine, classified under second-generation antipsychotics, is used across several of these applications, particularly for its dual action as an antidepressant and antipsychotic[5].

Key Players

Major pharmaceutical companies such as Bristol-Myers Squibb Company, Pfizer, Inc., Glaxo SmithKline, Plc, Eli Lilly & Co., Allergan, Johnson & Johnson, and AstraZeneca are key players in the antipsychotic drugs market. These companies are involved in various strategies including research and development, supply chain optimization, and market expansion to capture a larger share of the growing market[2][5].

Projections and Growth Opportunities

Market Growth Drivers

The growing incidence of mental health disorders and increased awareness about the importance of mental health treatment are significant drivers for the antipsychotic drugs market. Additionally, recent technological developments and innovations in drug delivery systems are expected to contribute to market growth[5].

Investment Opportunities

The antipsychotic drugs market offers several investment opportunities, particularly in the areas of research and development, and in expanding market reach to underserved regions. Companies are also focusing on developing new formulations and improving the safety and efficacy profiles of existing drugs like amoxapine[5].

Safety and Contraindications

Contraindications

Amoxapine is contraindicated in patients with prior hypersensitivity to dibenzoxazepine compounds and should not be given concomitantly with monoamine oxidase inhibitors due to the risk of hyperpyretic crises, severe convulsions, and deaths[1].

Pregnancy and Nursing

Amoxapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is also excreted in human milk, and caution should be exercised when administering it to nursing women[1].

New Uses and Research

Potential New Uses

Research has indicated that amoxapine and its metabolites may have new therapeutic uses. For example, computational modeling suggests that they could be potent inhibitors of certain enzymes, opening up possibilities for their use in other medical conditions[4].

Key Takeaways

  • Clinical Efficacy: Amoxapine has a rapid onset of action and is effective in treating various forms of depression.
  • Market Growth: The global antipsychotic drugs market, including amoxapine, is projected to grow at a CAGR of 2.5% to reach $14.91 billion by 2025.
  • Safety and Monitoring: Patients on amoxapine should be closely monitored for clinical worsening and suicidality.
  • New Uses: Amoxapine and its metabolites are being explored for potential new therapeutic applications.

FAQs

Q: What is the primary use of amoxapine?

A: Amoxapine is primarily used for the relief of symptoms of depression, including neurotic or reactive depressive disorders, endogenous and psychotic depressions, and depression accompanied by anxiety or agitation.

Q: How quickly does amoxapine take effect?

A: The initial clinical effect of amoxapine may occur within four to seven days, and over 80% of responders experience improvement within two weeks.

Q: What are the contraindications for amoxapine?

A: Amoxapine is contraindicated in patients with prior hypersensitivity to dibenzoxazepine compounds and should not be given concomitantly with monoamine oxidase inhibitors.

Q: Is amoxapine safe during pregnancy and breastfeeding?

A: Amoxapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is also excreted in human milk, and caution should be exercised when administering it to nursing women.

Q: What is the projected growth of the global antipsychotic drugs market?

A: The global antipsychotic drugs market is projected to grow at a CAGR of around 2.5% to reach approximately $14.91 billion by 2025.

Sources

  1. FDA Label: Amoxapine Label, FDA.
  2. Business Wire: Global Antipsychotic Drugs Market Analysis & Trends 2014-2016, Business Wire.
  3. Psychiatry Online: Validity of Clinical Trials of Antidepressants, Psychiatry Online.
  4. AACR Journals: Old Drug New Use—Amoxapine and Its Metabolites as Potent Inhibitors, AACR Journals.
  5. Business Insider: Global $14.91 Billion Antipsychotic Drugs Market Analysis & Trends 2014-2025, Business Insider.

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