CLINICAL TRIALS PROFILE FOR HALOPERIDOL DECANOATE

All Clinical Trials for Haloperidol Decanoate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00018642 ↗	Quetiapine vs Haloperidol Decanoate for the Long Term Treatment of Schizophrenia and Schizoaffective Disorder	Completed	US Department of Veterans Affairs	N/A	1997-04-01	The purpose of this research study is to determine whether a new drug for schizophrenia is better for the maintenance treatment than a standard drugs currently prescribed. The new medication is called quetiapine and it will be compared with a standard medication called haloperidol decanoate. The study will determine if quetiapine causes fewer problems than haloperidol with side effects such as stiffness and restlessness and whether it costs the VA more or less to treat patients with quetiapine. In addition, blood samples will be collected every three months to determine if certain chemicals in the blood can influence the outcome of the subjects' illness.
NCT00018642 ↗	Quetiapine vs Haloperidol Decanoate for the Long Term Treatment of Schizophrenia and Schizoaffective Disorder	Completed	VA Office of Research and Development	N/A	1997-04-01	The purpose of this research study is to determine whether a new drug for schizophrenia is better for the maintenance treatment than a standard drugs currently prescribed. The new medication is called quetiapine and it will be compared with a standard medication called haloperidol decanoate. The study will determine if quetiapine causes fewer problems than haloperidol with side effects such as stiffness and restlessness and whether it costs the VA more or less to treat patients with quetiapine. In addition, blood samples will be collected every three months to determine if certain chemicals in the blood can influence the outcome of the subjects' illness.
NCT00947375 ↗	Lamictal TM, Haloperidol Decanoate in Schizophrenia	Terminated	Central Mental Clinic for Outpatients of Baku City	Phase 4	2005-01-01	The purpose of this study is to determine the effect of lamotrigine augmentation of Haloperidol decanoate in the treatment of Resistant Schizophrenia predominantly by verbal resistant hallucinosis: A randomized, double-blind, placebo-controlled, study. Nadir A.Aliyev & Zafar N.Aliyev Central Mental Clinic for Outpatients of Baku city of Azerbaijan Republic Abstract: OBJECTIVE: The current paper reports on a double-blind, randomized study of the role of lamotrigine as an augmentation agent to haloperidol decanoate in the treatment of out patient's schizophrenia with verbal resistant hallucinosis.
NCT01136772 ↗	A Comparison of Long-acting Injectable Medications for Schizophrenia	Completed	Duke University	Phase 4	2011-03-01	The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).
NCT01136772 ↗	A Comparison of Long-acting Injectable Medications for Schizophrenia	Completed	National Institute of Mental Health (NIMH)	Phase 4	2011-03-01	The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).

Clinical Trial Conditions for Haloperidol Decanoate

Condition Name

Condition Name for Haloperidol Decanoate
Intervention	Trials
Schizophrenia	4
Schizoaffective Disorder	2
Schizophrenia and Disorders With Psychotic Features	1
Subsyndromal Delirium	1

Condition MeSH

Condition MeSH for Haloperidol Decanoate
Intervention	Trials
Schizophrenia	5
Psychotic Disorders	4
Delirium	2
Mental Disorders	2

Clinical Trial Locations for Haloperidol Decanoate

Trials by Country

Trials by Country for Haloperidol Decanoate
Location	Trials
United States	20
Azerbaijan	1
Tanzania	1
Nigeria	1

Trials by US State

Trials by US State for Haloperidol Decanoate
Location	Trials
Ohio	2
California	2
Texas	2
Pennsylvania	1
North Carolina	1

Clinical Trial Progress for Haloperidol Decanoate

Clinical Trial Phase

Clinical Trial Phase for Haloperidol Decanoate
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Haloperidol Decanoate
Clinical Trial Phase	Trials
Completed	5
Terminated	1
Unknown status	1

Clinical Trial Sponsors for Haloperidol Decanoate

Sponsor Name

Sponsor Name for Haloperidol Decanoate
Sponsor	Trials
Case Western Reserve University	2
National Institute of Mental Health (NIMH)	2
University Hospitals Cleveland Medical Center	1

Sponsor Type

Sponsor Type for Haloperidol Decanoate
Sponsor	Trials
Other	10
NIH	5
U.S. Fed	2

Haloperidol Decanoate: Clinical Trials, Market Analysis, and Projections

Introduction to Haloperidol Decanoate

Haloperidol decanoate is a depot antipsychotic medication, a long-acting formulation of haloperidol, which is used primarily in the treatment of schizophrenia. This medication is administered via intramuscular injection, providing a sustained release of the active ingredient over several weeks.

Clinical Efficacy and Trials

Comparison with Placebo and Oral Haloperidol

Clinical trials comparing haloperidol decanoate with placebo have shown that the drug is superior in managing schizophrenia. Studies involving 88 patients demonstrated that fewer patients receiving haloperidol decanoate withdrew from the studies compared to those receiving placebo, although the difference in Clinical Global Impression (CGI) scores and Brief Psychiatric Rating Scale (BPRS) scores was not significant[1].

Dosing and Symptomatic Exacerbation

A multicenter, double-blind study involving 105 outpatients with schizophrenia evaluated the efficacy of different doses of haloperidol decanoate. The study found that the 200-mg/month dose was associated with the lowest rate of symptomatic exacerbation (15%), with minimal increased risk of adverse effects compared to lower doses (100 mg and 50 mg)[4].

Patient Compliance and Outcomes

Haloperidol decanoate is particularly beneficial for chronic relapsing schizophrenic patients who have responded to oral haloperidol. It improves compliance and potentially enhances treatment outcomes by ensuring a consistent drug level over an extended period[3].

Market Analysis

Global Market Size and Growth

The global Haloperidol Decanoate API market is projected to grow significantly. As of 2023, the market is valued at approximately US$ 540 million and is expected to reach US$ 720.6 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 4.2% from 2023 to 2029[2][5].

Market Segmentation

The market is segmented by type (purity ≥99% and purity <99%) and application (injections and others). The purity ≥99% segment is expected to record a notable CAGR during the forecast period. The demand from the injection segment is a major driver of the market[2].

Regional Market

The global Haloperidol Decanoate API market is distributed across various regions, including North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics and growth prospects, with Asia Pacific expected to be a significant contributor due to its large population and growing healthcare needs[2].

Key Players

Major companies involved in the Haloperidol Decanoate API market include JANSSEN PHARMACEUTICA NV, TEVA PHARMACEUTICAL INDUSTRIES LTD, OLON SPA, MSN LIFE SCIENCES PRIVATE LTD, and MANKIND PHARMA LTD. These companies play a crucial role in the production, distribution, and innovation within the market[2].

Market Drivers and Restraints

Drivers

• Increasing Demand for Depot Antipsychotics: The need for long-acting antipsychotics to improve patient compliance and reduce relapse rates is a significant driver.
• Expanding Healthcare Infrastructure: Growing healthcare infrastructure and increasing access to mental health services in various regions are boosting the demand for Haloperidol Decanoate API[2].

Restraints

• Adverse Effects and Side Effects: Haloperidol decanoate, like other antipsychotics, can have adverse effects such as extrapyramidal symptoms, which may limit its use in some patients.
• Cost and Accessibility: The cost of the medication and its availability can be barriers, especially in low-income countries[3][4].

Future Projections

Market Growth

The market is expected to continue growing due to the increasing prevalence of schizophrenia and the need for effective long-term treatment options. The forecast indicates a steady growth rate, driven by the expanding demands from the injection segment and other applications[2].

Emerging Opportunities

• Advancements in Formulation: Research into new formulations and delivery systems could enhance the efficacy and safety of Haloperidol Decanoate.
• Global Health Initiatives: Initiatives aimed at improving mental health care globally could increase the demand for depot antipsychotics like Haloperidol Decanoate[2].

Key Takeaways

• Clinical Efficacy: Haloperidol decanoate is effective in managing schizophrenia, particularly in reducing symptomatic exacerbation.
• Market Growth: The global market is projected to grow at a CAGR of 4.2% from 2023 to 2029.
• Market Drivers: Increasing demand for depot antipsychotics and expanding healthcare infrastructure are key drivers.
• Restraints: Adverse effects and cost are significant restraints.
• Future Projections: The market is expected to grow, driven by emerging opportunities in formulation and global health initiatives.

FAQs

What is Haloperidol Decanoate used for?

Haloperidol decanoate is used primarily for the treatment of schizophrenia, particularly for chronic relapsing patients who have responded to oral haloperidol.

How is Haloperidol Decanoate administered?

Haloperidol decanoate is administered via intramuscular injection, providing a sustained release of the active ingredient over several weeks.

What are the key findings from clinical trials of Haloperidol Decanoate?

Clinical trials have shown that Haloperidol Decanoate is superior to placebo in managing schizophrenia and that the 200-mg/month dose has the lowest rate of symptomatic exacerbation.

What is the projected market size of Haloperidol Decanoate API by 2029?

The global Haloperidol Decanoate API market is expected to reach US$ 720.6 million by 2029, growing at a CAGR of 4.2% from 2023 to 2029.

Who are the major players in the Haloperidol Decanoate API market?

Major companies include JANSSEN PHARMACEUTICA NV, TEVA PHARMACEUTICAL INDUSTRIES LTD, OLON SPA, MSN LIFE SCIENCES PRIVATE LTD, and MANKIND PHARMA LTD.

Sources

1. BMJ Mental Health: "Haloperidol decanoate for schizophrenia"
2. QY Research: "Haloperidol Decanoate API - Global Market Insights and Sales"
3. CoLab: "Haloperidol Decanoate: A Depot Antipsychotic"
4. American Journal of Psychiatry: "A Multidose Study of Haloperidol Decanoate in the Maintenance Treatment of Schizophrenia"
5. DrugPatentWatch: "HALOPERIDOL DECANOATE historic drug sales"