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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR CHLORPROMAZINE HYDROCHLORIDE


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All Clinical Trials for Chlorpromazine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00122278 ↗ Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines Completed Montefiore Medical Center Phase 3 2005-07-01 Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
NCT00140179 ↗ Valnoctamide in Mania Completed Stanley Medical Research Institute Phase 3 2004-09-01 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00140179 ↗ Valnoctamide in Mania Completed Beersheva Mental Health Center Phase 3 2004-09-01 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00169039 ↗ Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia Terminated Commonwealth Research Center, Massachusetts Phase 4 1994-12-01 This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
NCT00169039 ↗ Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia Terminated Dartmouth-Hitchcock Medical Center Phase 4 1994-12-01 This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Chlorpromazine Hydrochloride

Condition Name

Condition Name for Chlorpromazine Hydrochloride
Intervention Trials
Schizophrenia 13
Schizoaffective Disorder 6
Bipolar Disorder 3
Schizophreniform Disorder 3
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Condition MeSH

Condition MeSH for Chlorpromazine Hydrochloride
Intervention Trials
Schizophrenia 16
Psychotic Disorders 10
Disease 6
Mental Disorders 6
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Clinical Trial Locations for Chlorpromazine Hydrochloride

Trials by Country

Trials by Country for Chlorpromazine Hydrochloride
Location Trials
United States 32
China 12
Spain 9
Taiwan 3
Canada 3
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Trials by US State

Trials by US State for Chlorpromazine Hydrochloride
Location Trials
Texas 4
New York 4
Ohio 2
Indiana 1
Illinois 1
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Clinical Trial Progress for Chlorpromazine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Chlorpromazine Hydrochloride
Clinical Trial Phase Trials
Phase 4 9
Phase 3 7
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Chlorpromazine Hydrochloride
Clinical Trial Phase Trials
Completed 21
Unknown status 5
Not yet recruiting 5
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Clinical Trial Sponsors for Chlorpromazine Hydrochloride

Sponsor Name

Sponsor Name for Chlorpromazine Hydrochloride
Sponsor Trials
Kaohsiung Kai-Suan Psychiatric Hospital 2
Stanley Medical Research Institute 2
Centre for Addiction and Mental Health 2
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Sponsor Type

Sponsor Type for Chlorpromazine Hydrochloride
Sponsor Trials
Other 61
Industry 7
NIH 4
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Chlorpromazine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Chlorpromazine Hydrochloride

Chlorpromazine hydrochloride, a pioneering antipsychotic medication, has been a cornerstone in the treatment of schizophrenia and other severe mental health disorders since its introduction in the 1950s. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Challenges

Historical Context and Current Limitations

Chlorpromazine marked a significant step forward in psychiatric treatment, but its mechanism of action, primarily through dopamine D2 receptor antagonism, has remained largely unchanged over the years. Despite this, challenges such as slow recruitment and high drop-out rates in clinical trials have hindered the development of new treatments for schizophrenia[1].

New Developments and Alternatives

Recent efforts have focused on developing new formulations and targeting different receptors. For instance, Karuna Therapeutics is working on KarXT, a drug that targets muscarinic receptors, which has shown promise in reducing both positive and negative symptoms of schizophrenia with fewer side effects compared to traditional dopamine-based treatments[1].

Ongoing and Upcoming Trials

Lyndra Therapeutics is currently advancing an oral weekly version of risperidone, another commonly prescribed antipsychotic, into its final pivotal safety study. Results are anticipated in 2025, followed by an NDA submission. This development aims to improve treatment adherence by eliminating the need for injections[1].

Market Analysis

Global Market Trends

The Chlorpromazine Hydrochloride market is experiencing significant growth driven by several factors:

  • Rising Prevalence of Mental Health Disorders: Increasing awareness and openness to seeking professional help for mental health issues have led to a higher demand for antipsychotic medications like Chlorpromazine hydrochloride[5].
  • Improvements in Mental Health Infrastructure: Investments in healthcare facilities, especially in developing regions, have expanded the market for psychiatric care. This includes the availability of skilled professionals and increased government funding[5].
  • Aging Population: The growing aging population, which is more prone to chronic mental health issues such as dementia and depression, is another key driver of market growth[5].

Market Segmentation and Projections

The Chlorpromazine Hydrochloride market is segmented based on type (purity levels), application (tablets, injection solutions), and geographical regions. The market is expected to grow at a remarkable CAGR from 2023 to 2031, driven by the increasing need for psychiatric care and advancements in healthcare infrastructure[2].

Key Market Drivers

  • Increased Demand for Psychiatric Care: The global mental health crisis has led to a surge in demand for effective antipsychotic drugs. Chlorpromazine hydrochloride remains a mainstay in treating severe mental disorders, particularly schizophrenia[5].
  • Advancements in Drug Formulations: Newer formulations, such as sustained-release and long-acting injectable versions, have improved patient outcomes and compliance. These innovations are driving the demand for Chlorpromazine products[5].

Market Projections

Revenue Growth and Expansion

The Chlorpromazine Hydrochloride market is projected to experience significant revenue growth during the forecast period from 2023 to 2031. This growth is attributed to the increasing prevalence of mental health disorders, improvements in healthcare infrastructure, and the aging population[2][5].

Investment Opportunities

The market offers substantial investment opportunities due to the rising demand for effective mental health treatments. Strategic partnerships, mergers, and acquisitions between pharmaceutical companies are expected to accelerate the development of more efficient and patient-friendly formulations of Chlorpromazine hydrochloride[5].

Geographical Expansion

Emerging markets, particularly in the Asia-Pacific and Latin America regions, are seeing significant growth due to investments in mental health care infrastructure. This expansion opens up new opportunities for pharmaceutical companies to increase their market presence in previously underserved regions[5].

Innovations and Recent Trends

New Drug Formulations

Recent years have seen the development of innovative formulations aimed at improving patient outcomes. Long-acting injectable versions of Chlorpromazine have been introduced, reducing the frequency of administration while ensuring consistent therapeutic effects. These advancements are driving the demand for Chlorpromazine products[5].

Partnerships and Collaborations

Pharmaceutical companies are increasingly partnering with research institutions to advance the science behind Chlorpromazine hydrochloride. These collaborations aim to improve drug efficacy, reduce side effects, and explore new therapeutic applications, further fueling market growth[5].

Conclusion

Chlorpromazine hydrochloride remains a crucial medication in the treatment of severe mental health disorders. Despite the challenges in clinical trials, new developments and innovative formulations are poised to enhance patient outcomes. The market for Chlorpromazine hydrochloride is expected to grow significantly, driven by the rising demand for psychiatric care, advancements in healthcare infrastructure, and the aging population.

Key Takeaways

  • Chlorpromazine hydrochloride continues to be a mainstay in psychiatric treatment due to its effectiveness in managing symptoms of schizophrenia and other mental health disorders.
  • New formulations and alternative treatments, such as KarXT and oral weekly risperidone, are being developed to address the limitations of traditional dopamine-based treatments.
  • The market is expected to grow significantly due to the increasing prevalence of mental health disorders, improvements in healthcare infrastructure, and the aging population.
  • Strategic partnerships and innovations in drug delivery systems are driving market growth and improving patient outcomes.

FAQs

Q: What are the primary challenges in the clinical trials for schizophrenia treatments?

A: The primary challenges include slow recruitment and high drop-out rates, as well as the reliance on legacy targets like dopamine and serotonin receptors, which can lead to side effects and limited efficacy[1].

Q: How is KarXT different from traditional schizophrenia treatments?

A: KarXT targets muscarinic receptors rather than dopamine receptors, which reduces the occurrence of side effects such as weight gain, metabolic issues, and uncontrolled movements commonly associated with traditional treatments[1].

Q: What are the key drivers of the Chlorpromazine Hydrochloride market growth?

A: The key drivers include the rising prevalence of mental health disorders, improvements in mental health infrastructure, and the aging population, which is more prone to chronic mental health issues[5].

Q: What are the recent innovations in Chlorpromazine hydrochloride formulations?

A: Recent innovations include the development of sustained-release and long-acting injectable versions of Chlorpromazine, which have improved patient outcomes and compliance[5].

Q: What investment opportunities are available in the Chlorpromazine Hydrochloride market?

A: The market offers significant investment opportunities through strategic partnerships, mergers, and acquisitions, as well as the development of more efficient and patient-friendly formulations of Chlorpromazine hydrochloride[5].

Sources

  1. PharmaVoice: "Big hopes for schizophrenia treatment rely on a deep pipeline of candidates" - March 6, 2024
  2. Market Research Intellect: "Global Chlorpromazine HCL Market Size, Trends and Projections" - December 2024
  3. DrugBank: "Chlorpromazine: Uses, Interactions, Mechanism of Action"
  4. Synapse by PatSnap: "Chlorpromazine Hydrochloride - Drug Targets, Indications, Patents"
  5. Market Research Intellect: "Pharma Industry Spotlight: The Surge in Chlorpromazine Hydrochloride Tablets Market"

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