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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR NORTRIPTYLINE HYDROCHLORIDE


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All Clinical Trials for Nortriptyline Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000375 ↗ Continuation Electroconvulsive Therapy Vs Medication to Prevent Relapses in Patients With Major Depressive Disorder Completed National Institute of Mental Health (NIMH) Phase 4 1997-02-01 The purpose of this study is to compare the safety and effectiveness of two treatments to prevent relapses in seriously ill patients with major depressive disorder (MDD) who have responded to electroconvulsive therapy (ECT). Patients will either continue to receive ECT (continuation electroconvulsive therapy [C-ECT]), or they will be treated with antidepressant medications. ECT is a highly effective treatment for MDD; however, relapses are a major concern. To prevent relapse in patients who have responded to ECT, the common treatment is antidepressants as continuation therapy (following the initial therapy in order to continue treating the disorder). Relapses, however, can still occur even after antidepressant continuation therapy. This study will evaluate a potent antidepressant combination in order to prevent relapse. C-ECT is another option that needs to be tested. If the patient responds to the first round of ECT, he/she will be assigned randomly (like tossing a coin) to either continue receiving ECT or to receive an antidepressant combination of nortriptyline plus lithium (NOR-Li) for 6 months. The patient will have psychological tests before, shortly after, and 3 months after the first round of ECT, and at the end of the 6-month continuation trial. Patients will be monitored for symptoms and side effects. All patients will have urine tests to test for drug abuse. An individual may be eligible for this study if he/she: Has major depressive disorder and responds positively to ECT treatment and is 18 to 80 years old.
NCT00000377 ↗ Preventing the Return of Depression in Elderly Patients Completed National Institute of Mental Health (NIMH) N/A 1989-03-01 The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. Nortriptyline is an antidepressant. This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment. Patients are treated for 4 months to bring the depression under control. Patients are then assigned randomly (like tossing a coin) to receive either the full dose of nortriptyline or half the usual dose of nortriptyline. Patients continue taking nortriptyline for 2 years or until a major depression returns. Throughout the study, patients are monitored for symptoms of depression and other side effects.
NCT00000377 ↗ Preventing the Return of Depression in Elderly Patients Completed University of Pittsburgh N/A 1989-03-01 The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. Nortriptyline is an antidepressant. This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment. Patients are treated for 4 months to bring the depression under control. Patients are then assigned randomly (like tossing a coin) to receive either the full dose of nortriptyline or half the usual dose of nortriptyline. Patients continue taking nortriptyline for 2 years or until a major depression returns. Throughout the study, patients are monitored for symptoms of depression and other side effects.
NCT00000378 ↗ Antidepressant Treatment of Melancholia in Late Life Completed National Institute of Mental Health (NIMH) Phase 4 1997-07-01 The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nortriptyline Hydrochloride

Condition Name

Condition Name for Nortriptyline Hydrochloride
Intervention Trials
Depression 11
Depressive Disorder 3
Treatment Resistant Depression 3
Major Depressive Disorder 3
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Condition MeSH

Condition MeSH for Nortriptyline Hydrochloride
Intervention Trials
Depression 18
Depressive Disorder 13
Depressive Disorder, Major 7
Migraine Disorders 4
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Clinical Trial Locations for Nortriptyline Hydrochloride

Trials by Country

Trials by Country for Nortriptyline Hydrochloride
Location Trials
United States 74
Brazil 5
Germany 4
Canada 3
Switzerland 2
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Trials by US State

Trials by US State for Nortriptyline Hydrochloride
Location Trials
California 9
Pennsylvania 7
Missouri 6
New York 6
North Carolina 5
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Clinical Trial Progress for Nortriptyline Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Nortriptyline Hydrochloride
Clinical Trial Phase Trials
Phase 4 20
Phase 3 6
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Nortriptyline Hydrochloride
Clinical Trial Phase Trials
Completed 29
Recruiting 7
Unknown status 5
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Clinical Trial Sponsors for Nortriptyline Hydrochloride

Sponsor Name

Sponsor Name for Nortriptyline Hydrochloride
Sponsor Trials
National Institute of Mental Health (NIMH) 8
VA Office of Research and Development 4
US Department of Veterans Affairs 3
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Sponsor Type

Sponsor Type for Nortriptyline Hydrochloride
Sponsor Trials
Other 62
U.S. Fed 16
NIH 15
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Nortriptyline Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Nortriptyline hydrochloride, a tricyclic antidepressant, has been a staple in the treatment of various psychiatric and neurological conditions for decades. This article delves into the current clinical trials, market analysis, and future projections for this versatile drug.

Clinical Trials Update

Concussion and Headache Treatment

A significant clinical trial currently underway is testing the efficacy of nortriptyline in reducing headache symptoms in patients who have suffered a concussion. This Phase 4 trial involves participants receiving either nortriptyline or a placebo in addition to standard treatments. The primary objective is to determine if nortriptyline can reduce headache symptoms faster than a placebo over a four-week period. Participants are monitored weekly for symptom changes, and the trial aims to assess the Post-Concussive Symptom Inventory (PSCI) score[1].

Functional Dyspepsia

Another clinical trial compares the efficacy of nortriptyline with duloxetine in alleviating symptoms of functional dyspepsia (FD). This single-blinded randomized trial involved 63 patients, with 45 completing the three-month treatment. The study found that nortriptyline significantly reduced the severity of FD symptoms, anxiety, and depression, and improved quality of life compared to duloxetine, particularly after three months of intervention[5].

Market Analysis

Global Market Size and Growth

The global nortriptyline hydrochloride market is projected to grow at a Compound Annual Growth Rate (CAGR) of 2.3% from 2024 to 2031, increasing from USD 239.7 million in 2023 to USD 287.52 million in 2031. This growth is driven by increasing incidences of nerve pain, mood disorders such as depression, and the rising prevalence of diabetic neuropathy[2][4].

Regional Market Dynamics

North America accounts for a significant share of the global nortriptyline hydrochloride market, largely due to a well-established healthcare sector and increasing investments in research and development. The region's high prevalence of depression, with over 8% of American adults affected, further supports market growth[2][4].

Product Forms and Purity

The market demand for nortriptyline hydrochloride is also influenced by the preference for high-purity formulations (more than 99%). Capsules are the most popular form, available in various strengths such as 75 mg, 50 mg, 25 mg, and 10 mg. The high efficacy of high-purity nortriptyline hydrochloride is a key factor in its increasing demand by academic, research, and medicine manufacturing sectors[2][4].

Market Drivers

Increasing Prevalence of Chronic Pain

The rising incidence of chronic pain, including neuropathic pain and diabetic neuropathy, is a major driver of the nortriptyline hydrochloride market. Nortriptyline's ability to reduce neuropathic pain by increasing noradrenaline levels and stimulating B2-adrenoceptors makes it a valuable treatment option[2][4].

Growing Prevalence of Mood Disorders

The increasing prevalence of mood disorders, such as depression, also contributes to the market growth. Nortriptyline's efficacy as a tricyclic antidepressant makes it a preferred treatment option in many regions, particularly in North America[2][4].

Research and Development Activities

The pharmaceutical sector's significant investments in research and development, including drug repurposing, are bolstering the demand for nortriptyline hydrochloride. Studies exploring its antitumor activities, particularly against gastric cancer, are further augmenting its market demand[3][4].

Drug Repurposing and New Applications

Antitumor Activities

Recent studies have highlighted nortriptyline hydrochloride's potential as an antitumor agent, particularly in the treatment of gastric cancer. It has been shown to inhibit gastric cancer cells by inducing oxidative stress and apoptosis, making it a promising candidate for drug repurposing[3].

Other Potential Applications

In addition to its antitumor properties, nortriptyline hydrochloride is being evaluated for its potential in treating other conditions. Its versatility and well-understood side effect profile make it an attractive option for various therapeutic applications[3][4].

Side Effects and Safety Profile

Common Side Effects

Nortriptyline hydrochloride can cause several side effects, including mood swings, weight gain, dry mouth, and dizziness upon standing up quickly (orthostatic hypotension). It may also worsen psychiatric conditions in some patients[1].

High-Purity Formulations

The preference for high-purity nortriptyline hydrochloride is partly due to its high efficacy and better-understood side effect profile compared to lower purity formulations[2][4].

Key Players and Market Landscape

Pharmaceutical Industry Investments

The pharmaceutical industry's significant investments in research and development activities are driving the growth of the nortriptyline hydrochloride market. Companies are focusing on developing novel medications, which involves substantial research and development expenditures, further propelling the demand for nortriptyline hydrochloride[2][4].

Market Share and Competitive Intelligence

Leading players in the industry are expanding their market share through strategic investments in research, development, and marketing. The competitive landscape is characterized by a mix of established pharmaceutical companies and emerging players focusing on drug repurposing and new therapeutic applications[4].

Future Projections

Market Growth and Opportunities

The global nortriptyline hydrochloride market is expected to continue its growth trajectory, driven by increasing demand from the research and academic sectors, as well as from medicine manufacturing facilities. The rising prevalence of chronic pain and mood disorders will remain key drivers of market growth[2][4].

Emerging Trends and Challenges

Emerging trends include the increasing focus on drug repurposing and the development of high-purity formulations. However, challenges such as the need for continuous research to validate new therapeutic applications and the potential for side effects will need to be addressed to sustain market growth[3][4].

Key Takeaways

  • Clinical Trials: Nortriptyline hydrochloride is being tested for its efficacy in treating headaches after concussions and functional dyspepsia.
  • Market Growth: The global market is projected to grow at a CAGR of 2.3% from 2024 to 2031.
  • Regional Dynamics: North America is a significant market due to its well-established healthcare sector and high prevalence of depression.
  • Product Forms: Capsules are the most popular form, with a preference for high-purity formulations.
  • Market Drivers: Increasing prevalence of chronic pain and mood disorders, along with research and development activities.
  • Drug Repurposing: Nortriptyline hydrochloride shows potential as an antitumor agent, particularly against gastric cancer.

FAQs

What is the primary use of nortriptyline hydrochloride in current clinical trials?

Nortriptyline hydrochloride is being tested primarily for its efficacy in reducing headache symptoms after concussions and alleviating symptoms of functional dyspepsia.

What is the projected growth rate of the global nortriptyline hydrochloride market?

The global nortriptyline hydrochloride market is projected to grow at a CAGR of 2.3% from 2024 to 2031.

Which region accounts for a significant share of the nortriptyline hydrochloride market?

North America accounts for a significant share of the global nortriptyline hydrochloride market due to its well-established healthcare sector and high prevalence of depression.

What are the common side effects of nortriptyline hydrochloride?

Common side effects include mood swings, weight gain, dry mouth, and dizziness upon standing up quickly (orthostatic hypotension).

What new therapeutic applications are being explored for nortriptyline hydrochloride?

Nortriptyline hydrochloride is being explored for its antitumor activities, particularly in the treatment of gastric cancer, and other potential therapeutic applications through drug repurposing.

Sources

  1. WithPower: Nortriptyline for Concussion Clinical Trial 2024.
  2. Market Xcel: Nortriptyline Hydrochloride Market Assessment, By Purity, By Form.
  3. PubMed: Nortriptyline hydrochloride, a potential candidate for drug repurposing.
  4. Markets and Data: Global Nortriptyline Hydrochloride Market Size 2031.
  5. Frontiers in Psychiatry: Comparing the efficacy of duloxetine and nortriptyline in alleviating symptoms of functional dyspepsia.

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