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Last Updated: March 25, 2025

CLINICAL TRIALS PROFILE FOR IMIPRAMINE HYDROCHLORIDE


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All Clinical Trials for Imipramine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000368 ↗ Treatment of Panic Disorder: Long Term Strategies Completed National Institute of Mental Health (NIMH) Phase 3 1999-02-01 Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) to determine the acute acceptability and efficacy of medication therapy or continued CBT alone among patients who fail to respond sufficiently to an initial course of CBT alone. It has been found that patients with PD respond as well to CBT or medication alone as they do to a combination of the two. Since the combined treatments are expensive and CBT is associated with less risk of medical toxicity compared to medications, CBT alone will be used first. All patients will first receive CBT alone. If the patient responds to this therapy, the patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will continue to receive CBT (maintenance therapy) for 9 months. The other group of responders will not receive any further therapy. If a patient does not respond to CBT alone, he/she will be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other will continue to receive CBT for a longer period. The response to treatment will be evaluated to see which regimen works best to treat PD. The study will last approximately 3 years. An individual may be eligible for this study if he/she has panic disorder with no more than mild agoraphobia (fear of being in public places) and is at least 18 years old.
NCT00000368 ↗ Treatment of Panic Disorder: Long Term Strategies Completed New York State Psychiatric Institute Phase 3 1999-02-01 Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) to determine the acute acceptability and efficacy of medication therapy or continued CBT alone among patients who fail to respond sufficiently to an initial course of CBT alone. It has been found that patients with PD respond as well to CBT or medication alone as they do to a combination of the two. Since the combined treatments are expensive and CBT is associated with less risk of medical toxicity compared to medications, CBT alone will be used first. All patients will first receive CBT alone. If the patient responds to this therapy, the patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will continue to receive CBT (maintenance therapy) for 9 months. The other group of responders will not receive any further therapy. If a patient does not respond to CBT alone, he/she will be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other will continue to receive CBT for a longer period. The response to treatment will be evaluated to see which regimen works best to treat PD. The study will last approximately 3 years. An individual may be eligible for this study if he/she has panic disorder with no more than mild agoraphobia (fear of being in public places) and is at least 18 years old.
NCT00000390 ↗ Antidepressant Treatment of AIDS Related Depression. Completed GEIGY Pharmaceuticals Phase 2 1969-12-31 To test the effectiveness treating AIDS related depression with imipramine hydrochloride. Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status. This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.
NCT00000464 ↗ Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1987-04-01 To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000464 ↗ Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) Completed University of Washington Phase 3 1987-04-01 To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000504 ↗ Cardiac Arrhythmia Pilot Study (CAPS) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1982-09-01 To compare the effectiveness of various drugs and drug combinations in suppressing complex ventricular arrhythmias, and to evaluate their safety.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Imipramine Hydrochloride

Condition Name

Condition Name for Imipramine Hydrochloride
Intervention Trials
Depression 9
Heart Diseases 4
Cardiovascular Diseases 4
Major Depression 4
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Condition MeSH

Condition MeSH for Imipramine Hydrochloride
Intervention Trials
Depression 16
Depressive Disorder 14
Depressive Disorder, Major 10
Disease 5
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Clinical Trial Locations for Imipramine Hydrochloride

Trials by Country

Trials by Country for Imipramine Hydrochloride
Location Trials
United States 21
Denmark 6
Canada 3
Switzerland 3
Germany 2
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Trials by US State

Trials by US State for Imipramine Hydrochloride
Location Trials
New York 5
Ohio 3
Pennsylvania 2
Texas 2
Maryland 2
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Clinical Trial Progress for Imipramine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Imipramine Hydrochloride
Clinical Trial Phase Trials
Phase 4 9
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Imipramine Hydrochloride
Clinical Trial Phase Trials
Completed 37
Recruiting 5
Unknown status 4
[disabled in preview] 6
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Clinical Trial Sponsors for Imipramine Hydrochloride

Sponsor Name

Sponsor Name for Imipramine Hydrochloride
Sponsor Trials
New York State Psychiatric Institute 4
National Heart, Lung, and Blood Institute (NHLBI) 4
National Institute of Mental Health (NIMH) 3
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Sponsor Type

Sponsor Type for Imipramine Hydrochloride
Sponsor Trials
Other 71
NIH 8
Industry 7
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Imipramine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Imipramine hydrochloride, a tricyclic antidepressant, has been in use for decades to treat depression, anxiety disorders, and other conditions. Recently, it has garnered significant attention for its potential in cancer treatment, particularly in targeting the protein Fascin1. Here, we delve into the current clinical trials, market analysis, and future projections for imipramine hydrochloride.

Clinical Trials: A New Frontier in Cancer Treatment

Fascin1 and Cancer Invasion

Fascin1 is a protein crucial for the formation of actin bundles, which are essential for the invasion and metastasis of cancer cells. Recent studies have shown that imipramine can block Fascin1, preventing the formation of these actin bundles and thereby inhibiting cancer cell invasion and metastasis[1].

The HITCLIF Trial

A significant clinical trial, the HITCLIF trial, is currently underway to evaluate the efficacy of imipramine in patients with localized colon, rectal, and triple-negative breast cancer who overexpress Fascin1. This multicenter, double-blind, placebo-controlled trial randomizes patients to receive either imipramine or a placebo, with some patients receiving imipramine concomitantly with neoadjuvant chemotherapy. The primary endpoint is the alteration in prognostic histopathological features at the invasive margins of the tumors[1].

Other Clinical Trials

In addition to the HITCLIF trial, imipramine is being investigated in various other clinical settings. For example, it is being studied in combination with lomustine for recurrent glioblastoma and as a treatment for oral squamous cell carcinoma, where it has shown promise in inhibiting tumor growth and inducing apoptosis[4].

Market Analysis: Current Trends and Projections

Market Size and Growth

The imipramine hydrochloride market has experienced substantial growth in recent years and is anticipated to continue this trend. The market size is projected to expand significantly from 2023 to 2031, driven by increasing demand for the drug in both its traditional applications and new therapeutic areas such as cancer treatment[2][5].

Segmentation and Application

The market is segmented based on type (12.5mg, 25mg), application (depression, anxiety disorders, bedwetting), and geographical regions. The report highlights that the market dynamics are influenced by factors such as product pricing, penetration at national and regional levels, and the economic, political, and social landscapes of countries[2][5].

Geographical Insights

North America currently dominates the imipramine hydrochloride market, but the Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period. This growth is attributed to increasing R&D activities and a rising demand for pharmaceuticals in these regions[2][5].

Market Drivers and Restraints

Drivers

  • Increasing R&D Activities: The pharmaceutical and biotechnology industries are investing heavily in research and development, which is driving the growth of the imipramine hydrochloride market.
  • Expanding Therapeutic Applications: The potential use of imipramine in cancer treatment, particularly in targeting Fascin1, is a significant driver for market growth.
  • Growing Demand for Mental Health Treatments: The increasing prevalence of mental health disorders is contributing to the demand for imipramine hydrochloride[2][5].

Restraints

  • Side Effects and Adverse Reactions: Imipramine hydrochloride can have significant side effects, which may limit its adoption in some patient populations.
  • Regulatory Hurdles: The approval process for new therapeutic applications can be lengthy and challenging, potentially restraining market growth[2][5].

Future Projections

Continued Growth in Traditional Applications

Imipramine hydrochloride is expected to continue its strong performance in treating depression, anxiety disorders, and other traditional indications. The market is anticipated to grow steadily, driven by the increasing prevalence of these conditions and the drug's established efficacy[2].

Emerging Role in Cancer Treatment

The potential of imipramine hydrochloride in cancer treatment, particularly in targeting Fascin1, is a promising area of growth. Successful clinical trials, such as the HITCLIF trial, could significantly expand the market for this drug in the oncology sector[1].

Impact of Digital Health Innovations

The integration of digital health technologies, such as wearables and sensors, into clinical trials is expected to enhance the development and approval process of drugs like imipramine hydrochloride. This could lead to more efficient and effective clinical trials, further driving market growth[3].

Key Takeaways

  • Clinical Trials: Imipramine hydrochloride is being investigated in several clinical trials, notably the HITCLIF trial, for its potential in treating cancers with Fascin1 overexpression.
  • Market Growth: The market for imipramine hydrochloride is projected to grow significantly from 2023 to 2031, driven by increasing demand and expanding therapeutic applications.
  • Geographical Insights: North America currently leads the market, but the Asia-Pacific region is expected to grow at the fastest CAGR.
  • Drivers and Restraints: The market is driven by R&D activities, expanding therapeutic applications, and growing demand for mental health treatments, but is restrained by side effects and regulatory hurdles.

FAQs

What is the primary focus of the HITCLIF clinical trial?

The HITCLIF trial is focused on evaluating the efficacy of imipramine hydrochloride in patients with localized colon, rectal, and triple-negative breast cancer who overexpress Fascin1.

How does imipramine hydrochloride affect cancer cells?

Imipramine hydrochloride blocks Fascin1, preventing the formation of actin bundles, which are essential for the invasion and metastasis of cancer cells.

What are the traditional applications of imipramine hydrochloride?

Imipramine hydrochloride is traditionally used to treat depression, anxiety disorders, and bedwetting.

What is the projected market size of imipramine hydrochloride by 2031?

The market size of imipramine hydrochloride is anticipated to reach a significant value by 2031, although exact figures are not specified in the available reports.

How is digital health innovation impacting the development of imipramine hydrochloride?

Digital health innovations, such as the use of wearables and sensors, are enhancing clinical trial outcomes and could lead to more efficient and effective development and approval processes for imipramine hydrochloride.

Sources

  1. PubMed: Effects of imipramine on cancer patients over-expressing Fascin1.
  2. Market Research Intellect: Imipramine Hydrochloride Market Size, Scope And Forecast Report.
  3. BioSpace: Clinical Trials Market is Rising Rapidly Up to USD 95 BN by 2030.
  4. LARVOL VERI: News - imipramine.
  5. Market Research Intellect: Global Imipramine HCL API Market Size, Scope And Forecast Report.

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