CLINICAL TRIALS PROFILE FOR CHLORDIAZEPOXIDE HYDROCHLORIDE

All Clinical Trials for CHLORDIAZEPOXIDE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT00855699 ↗	Alcohol Detoxification in Primary Care Treatment (ADEPT)	Completed	University of Bristol	Phase 4	2009-11-01	Once someone becomes dependent on alcohol (alcoholic), the risks of complications from alcohol withdrawal when they stop drinking grow. These can include a life-threatening fit or delirium tremens (see things, become frightened). To prevent such complications, people take medication such as benzodiazepines (e.g., valium or librium) in reducing doses for about a week; this is called detoxification or 'detox.' In the UK effective alcohol treatment exists but little is known about what is the best detox medication. Alternative drugs to benzodiazepines appear to protect the brain from the toxicity of alcohol withdrawal and to reduce the likelihood of drinking again. This study will examine the feasibility of comparing medication regimens for alcohol detox for the first time in primary care. It will include a standard detox regimen (librium over 8 days) alone and together with a drug, acamprosate, that has been shown to reduce toxicity of alcohol withdrawal in preclinical models and is used after detox to help people remain sober. It will focus on the practicalities of doing such a study as well as assessing how people feel (withdrawal symptoms) and do (drinking during first month).
NCT00202514 ↗	Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms	Completed	Abbott	Phase 2/Phase 3	2004-09-01	The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.
NCT00202514 ↗	Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms	Completed	Seattle Institute for Biomedical and Clinical Research	Phase 2/Phase 3	2004-09-01	The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.
NCT01573052 ↗	Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal	Completed	VA Salt Lake City Health Care System	Phase 4	2004-03-01	A randomized, double-blind controlled trial comparing treatment outcomes between chlordiazepoxide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent veteran subjects. The objective of this trial is to compare the safety and effectiveness of these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence, withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and alcohol craving.
NCT00136617 ↗	Outpatient Treatment of Alcohol Withdrawal Syndrome	Completed	Hvidovre University Hospital	Phase 3	2003-08-01	The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients. Objectives: - Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication - Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome - Outpatient treatment of alcohol withdrawal syndrome

Clinical Trial Conditions for CHLORDIAZEPOXIDE HYDROCHLORIDE

Condition Name

Condition Name for CHLORDIAZEPOXIDE HYDROCHLORIDE
Intervention	Trials
Alcoholism	3
Alcohol Withdrawal	2
Atrial Fibrillation	1
Diabetes Mellitus	1

Condition MeSH

Condition MeSH for CHLORDIAZEPOXIDE HYDROCHLORIDE
Intervention	Trials
Alcoholism	3
Substance Withdrawal Syndrome	2
Behavior, Addictive	1
Atrial Fibrillation	1

Clinical Trial Locations for CHLORDIAZEPOXIDE HYDROCHLORIDE

Trials by Country

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Trials by Country for CHLORDIAZEPOXIDE HYDROCHLORIDE
Location	Trials
United States	3
Taiwan	1
Denmark	1
Brazil	1
United Kingdom	1

Trials by US State

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−

Trials by US State for CHLORDIAZEPOXIDE HYDROCHLORIDE
Location	Trials
Minnesota	1
Utah	1
Washington	1

Clinical Trial Progress for CHLORDIAZEPOXIDE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CHLORDIAZEPOXIDE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for CHLORDIAZEPOXIDE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	7
Withdrawn	1

Clinical Trial Sponsors for CHLORDIAZEPOXIDE HYDROCHLORIDE

Sponsor Name

Sponsor Name for CHLORDIAZEPOXIDE HYDROCHLORIDE
Sponsor	Trials
Hvidovre University Hospital	1
Abbott	1
Seattle Institute for Biomedical and Clinical Research	1

Sponsor Type

Sponsor Type for CHLORDIAZEPOXIDE HYDROCHLORIDE
Sponsor	Trials
Other	9
Industry	1
U.S. Fed	1

Clinical Trials, Market Analysis, and Projections for Chlordiazepoxide Hydrochloride

Introduction to Chlordiazepoxide Hydrochloride

Chlordiazepoxide hydrochloride, a long-acting benzodiazepine, has been a cornerstone in the management of anxiety disorders, alcohol withdrawal, and preoperative anxiety since its FDA approval in 1960. Here, we delve into the current clinical trials landscape, market analysis, and future projections for this drug.

Clinical Trials and Pipeline Overview

While chlordiazepoxide hydrochloride itself is not in the pipeline for new clinical trials, the broader psychiatric medications pipeline is robust. As of June 2024, there are numerous psychiatric medications in Phase III clinical trials, although none specifically for chlordiazepoxide hydrochloride. These trials include various psychiatric disorders such as schizophrenia, bipolar disorders, depressive disorders, anxiety disorders, PTSD, OCD, and others[1].

However, the focus on anxiety disorders and alcohol withdrawal, where chlordiazepoxide is primarily used, indicates ongoing research in related therapeutic areas. This research can lead to better treatment protocols and potentially new formulations or adjunct therapies that could impact the use of chlordiazepoxide hydrochloride.

Mechanism of Action and Therapeutic Uses

Chlordiazepoxide hydrochloride works by enhancing the activity of neurotransmitters in the brain, specifically by binding to benzodiazepine receptors at the GABA-A ligand-gated chloride channel complex. This action results in anti-anxiety, sedative, appetite-stimulating, and myorelaxant effects. It is FDA-approved for managing mild-to-severe anxiety, preoperative anxiety, and alcohol withdrawal symptoms in adults, as well as anxiety in pediatric patients aged 6 and older[4].

Market Analysis

Current Market Size and Growth

The chlordiazepoxide hydrochloride market has been experiencing significant growth driven by several factors. As of 2023, the market size was valued at USD 472.8 million and is projected to reach USD 652.8 million by 2031, growing at a CAGR of 3.6% from 2024 to 2031[2].

Market Drivers

• Rising Prevalence of Anxiety Disorders: The increasing global prevalence of anxiety disorders and alcohol dependency is a major driver. The de-stigmatization of seeking mental health treatment and growing awareness of mental health issues also contribute to market expansion[2][3].
• Aging Population: The elderly population, which is more vulnerable to anxiety and alcohol use disorders, is another significant factor driving demand[2][3].
• Generic Versions and Healthcare Access: The availability of generic versions and expanding healthcare access in emerging nations are key factors fueling market growth[2][3].

Market Segmentation

The market is segmented based on type (tablets, capsules, oral solutions, injections, disintegrating tablets), application (anxiety disorders, alcohol withdrawal symptoms, sedation, insomnia), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2][5].

Competitive Landscape

The market is competitive, with several players involved in the production and distribution of chlordiazepoxide hydrochloride. The report includes a comprehensive analysis of the competitive landscape, covering market share, strategic approaches, product range, and regulatory approvals of leading market players[3][5].

Market Projections

Future Growth

The market for chlordiazepoxide hydrochloride is expected to continue growing due to the increasing demand for mental health treatments. The expansion of healthcare systems and the availability of generic versions in emerging markets will drive this growth. Additionally, innovations in drug formulation and delivery methods, along with the integration of telemedicine for increased access to psychiatric consultations, will contribute to the market's future growth[2][3][5].

Opportunities and Challenges

• Opportunities: The expanding use of chlordiazepoxide in combination therapy with other psychiatric medications, the rising need for affordable anti-anxiety treatments, and the untapped potential in emerging pharmaceutical markets present significant opportunities[3].
• Challenges: Strict regulatory controls, potential side effects, the risk of substance dependency, and growing competition from newer anxiolytics with better safety profiles are challenges that the market faces[3].

Key Takeaways

• Clinical Trials: While chlordiazepoxide hydrochloride itself is not in new clinical trials, the broader psychiatric medications pipeline is active.
• Market Size and Growth: The market was valued at USD 472.8 million in 2023 and is projected to reach USD 652.8 million by 2031.
• Market Drivers: Rising prevalence of anxiety disorders, aging population, and expanding healthcare access are key drivers.
• Market Segmentation: Segmented by type, application, and geographical regions.
• Future Growth: Driven by increasing demand for mental health treatments, innovations in drug formulation, and expanding healthcare systems.

FAQs

What are the primary therapeutic uses of chlordiazepoxide hydrochloride?

Chlordiazepoxide hydrochloride is primarily used for managing mild-to-severe anxiety, preoperative anxiety, and alcohol withdrawal symptoms in adults, as well as anxiety in pediatric patients aged 6 and older[4].

What are the key drivers of the chlordiazepoxide hydrochloride market?

The key drivers include the rising global prevalence of anxiety disorders and alcohol dependency, the aging population, and the expanding healthcare access in emerging nations[2][3].

What are the challenges facing the chlordiazepoxide hydrochloride market?

Challenges include strict regulatory controls, potential side effects, the risk of substance dependency, and growing competition from newer anxiolytics with better safety profiles[3].

How is the market for chlordiazepoxide hydrochloride segmented?

The market is segmented based on type (tablets, capsules, oral solutions, injections, disintegrating tablets), application (anxiety disorders, alcohol withdrawal symptoms, sedation, insomnia), and geographical regions[2][5].

What is the projected growth of the chlordiazepoxide hydrochloride market?

The market is projected to grow from USD 472.8 million in 2023 to USD 652.8 million by 2031, at a CAGR of 3.6% from 2024 to 2031[2].

Sources

1. Innovations CNS: "Psychiatric Medications in the Pipeline in Phase III Clinical Trials up to June 1, 2024"[1].
2. Market Research Intellect: "Global Chlordiazepoxide Hydrochloride Market Size and Projections"[2].
3. 360iResearch: "Chlordiazepoxide Tablets Market Size & Share 2025-2030"[3].
4. NCBI StatPearls: "Chlordiazepoxide"[4].
5. Market Research Pulse: "Chlordiazepoxide Hydrochloride Market Trends, Scope And Outlook"[5].