CLINICAL TRIALS PROFILE FOR PERPHENAZINE

All Clinical Trials for Perphenazine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00009204 ↗	Serotonergic Pharmacotherapy for Agitation of Dementia	Completed	National Institute of Mental Health (NIMH)	Phase 3	1995-09-01	This study is a randomized, double-blind, placebo-controlled, fixed dose study currently being conducted on two geropsychiatric units at Western Psychiatric Institute and Clinic. It seeks to evaluate the short-term safety and efficacy of citalopram and perphenazine in the treatment of 112 patients suffering from behavioral disturbances associated with dementia. Findings from this research may directly lead to improved acute pharmacotherapy for psychosis and behavioral problems in patients diagnosed with dementia. Improved treatment of behavioral complications with reduced side effects would reduce excess disability in patients diagnosed with dementia, allowing them to be maintained in the community for greater periods of time.
NCT00009204 ↗	Serotonergic Pharmacotherapy for Agitation of Dementia	Completed	Bruce Pollock	Phase 3	1995-09-01	This study is a randomized, double-blind, placebo-controlled, fixed dose study currently being conducted on two geropsychiatric units at Western Psychiatric Institute and Clinic. It seeks to evaluate the short-term safety and efficacy of citalopram and perphenazine in the treatment of 112 patients suffering from behavioral disturbances associated with dementia. Findings from this research may directly lead to improved acute pharmacotherapy for psychosis and behavioral problems in patients diagnosed with dementia. Improved treatment of behavioral complications with reduced side effects would reduce excess disability in patients diagnosed with dementia, allowing them to be maintained in the community for greater periods of time.
NCT00014001 ↗	CATIE- Schizophrenia Trial	Completed	National Institute of Mental Health (NIMH)	Phase 4	2000-12-01	The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.
NCT00190021 ↗	Donepezil Treatment of Psychotic Symptoms in Dementia Patients	Unknown status	Beersheva Mental Health Center	Phase 3	1969-12-31	Conventional psychotropic medications may be used to treat behavioral disturbances and psychotic symptoms in patients with dementia and they are the drugs of choice for treating delusions and hallucinations. However the sensitivity to side effects in these patients often restricts the use of these agents (2, 3). Although, atypical antipsychotics have some advantages compared with conventional neuroleptics, they also are associated with side effects (5, 6). Cholinesterase inhibitors (ChEIs) enhance neuronal transmission by increasing the availability of acetylcholine in muscarinic and nicotinic receptors. According to findings of some researchers ChEIs have psychotropic effects and may play an important role in controlling neuropsychiatric and behavioral disturbances in patients with Alzheimer's disease (7-10). These agents may also contribute to the management of other disorders with cholinergic system abnormalities and neuropsychiatric symptoms such as visual hallucinations (11). Donepezil is a piperidine-based reversible, noncompetitive ChEI, which is indicated in the management of patients with Alzheimer's disease of mild to moderate severity (12-14). Preliminary observations suggest the possible value of ChEIs in the amelioration of psychotic symptoms in patients with dementia of the Alzheimer's type (DAT), dementia with Lewy bodies and patients suffering from Parkinson's disease (11-18). The results of our study (18) indicate that the addition of donepezil to perphenazine resulted in qualitatively superior clinical gains compared to higher doses of neuroleptic therapy without donepezil. The finding of the pilot study although impressive, stem from data regarding a rather small sample. The present (second) phase of the study will include a larger sample of patients. We now intend to examine 80 inpatients, aged 65-90 years old, suffering from DAT.
NCT00480246 ↗	A Positron Emission Tomography (PET) Study to Assess the Degree of Dopamine-2 (D2) Receptor Occupancy in the Human Brain After Single Doses of BL-1020 or Perphenazine in Healthy Male Subjects Using [11C]Raclopride as PET Tracer	Completed	BioLineRx, Ltd.	Phase 1	2007-05-01	This is a single dose, open-label, 2-panel (Parts A and B) PET study investigating the degree of occupancy of dopamine 2 receptors (D2_RO) in the human brain after single oral doses of BL-1020 or Perphenazine (Trilafon®, hereafter called Perphenazine) in healthy male subjects. In Part A the D2_RO is investigated for the study compound BL-1020 and in Part B the D2_RO of BL-1020 is compared to the D2_RO of Perphenazine, a reference compound.
NCT00563992 ↗	Effectiveness of Lithium and Valproate in Treating High-Risk Bipolar Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 1	2001-01-01	This study will evaluate the effectiveness of two different mood stabilizing medications, lithium and valproate, in treating people with bipolar disorder and suicidal behavior.

Clinical Trial Conditions for Perphenazine

Condition Name

Condition Name for Perphenazine
Intervention	Trials
Schizophrenia	14
Bipolar Disorder	4
Psychotic Disorders	3
Schizoaffective Disorder	3

Condition MeSH

Condition MeSH for Perphenazine
Intervention	Trials
Schizophrenia	14
Psychotic Disorders	7
Disease	6
Alzheimer Disease	4

Clinical Trial Locations for Perphenazine

Trials by Country

Trials by Country for Perphenazine
Location	Trials
United States	112
Germany	4
Canada	3
Mexico	2
Israel	2

Trials by US State

Trials by US State for Perphenazine
Location	Trials
New York	8
Pennsylvania	7
California	6
Texas	6
Florida	5

Clinical Trial Progress for Perphenazine

Clinical Trial Phase

Clinical Trial Phase for Perphenazine
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	6
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Perphenazine
Clinical Trial Phase	Trials
Completed	17
Recruiting	5
Unknown status	2

Clinical Trial Sponsors for Perphenazine

Sponsor Name

Sponsor Name for Perphenazine
Sponsor	Trials
National Institute of Mental Health (NIMH)	6
Janssen Scientific Affairs, LLC	3
Maastricht University	2

Sponsor Type

Sponsor Type for Perphenazine
Sponsor	Trials
Other	36
Industry	8
NIH	7

Perphenazine: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Perphenazine is a well-established antipsychotic medication that has been in use since its approval in 1957. It is utilized in various therapeutic areas, including the treatment of schizophrenia, nausea and vomiting, and other conditions. This article delves into the clinical trials, market analysis, and projections for Perphenazine, providing a holistic view of its current and future standing.

Clinical Trials and Efficacy

The CATIE Schizophrenia Trial

One of the significant clinical trials involving Perphenazine is the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) program initiated by the National Institute of Mental Health. This trial aimed to evaluate the effectiveness of antipsychotic drugs, including Perphenazine, in real-world clinical settings. The CATIE schizophrenia trial compared Perphenazine, a mid-potency first-generation antipsychotic, with second-generation antipsychotics such as olanzapine, quetiapine, risperidone, and ziprasidone. The trial allowed for subjects to receive subsequent treatments if the initial medication was not effective, providing valuable insights into the efficacy and tolerability of Perphenazine in comparison to other antipsychotics[1].

Mechanism of Action and Therapeutic Uses

Perphenazine primarily targets the D2 receptor, which is involved in various physiological processes. This mechanism of action makes it effective in treating conditions such as schizophrenia, Meniere Disease, postoperative nausea and vomiting, and other forms of vomiting. The drug's ability to modulate the D2 receptor activity provides therapeutic benefits for patients suffering from these conditions[3].

Market Analysis

Global Market Growth

The global Perphenazine market is expected to experience significant growth during the forecast period of 2020-2025. Reports from various market research firms indicate that the market will develop at a speedy pace, driven by emerging trends, major drivers, and opportunities in the industry. The market is segmented by types (oral forms and injectable solutions) and applications (psychosis, antiemetic uses), with a global outreach across regions including North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[2][5].

Market Segmentation and Key Players

The Perphenazine market is categorized based on its forms and applications. Oral forms and injectable solutions are the primary types, while the drug is used to treat psychosis and as an antiemetic. Key players in the market include Teva, Sandoz, Endo, Mylan, and ZHPHARMA, among others. These companies are driving the market through their business strategies, innovations, and developments[5].

Regional Market Scope

The global Perphenazine market is analyzed across various regions, each with its own market size, sales, and revenue projections. North America, Europe, and the Asia-Pacific region are significant contributors to the global market, with countries like the United States, Canada, Germany, France, China, Japan, and India playing crucial roles. The market in these regions is influenced by factors such as local healthcare policies, patient demographics, and the availability of alternative treatments[2][5].

Market Projections

Forecasted Growth

The Perphenazine market is forecasted to reach significant growth by 2025, with projected revenues indicating a robust market expansion. The market is expected to be valued at over $100 million by 2025, driven by increasing demand for effective antipsychotic and antiemetic treatments. Innovations in drug delivery systems and the expanding use of Perphenazine in various therapeutic areas are key drivers of this growth[5].

Challenges and Opportunities

Despite the positive growth projections, the Perphenazine market faces challenges such as the risk of side effects like tardive dyskinesia, hematologic effects, and hepatic effects. These challenges necessitate careful monitoring and management by healthcare providers. However, the broad range of applications and the ongoing research to improve the drug's safety and efficacy present significant opportunities for market growth[4].

Key Takeaways

• Clinical Efficacy: Perphenazine has been evaluated in significant clinical trials like the CATIE schizophrenia trial, demonstrating its efficacy in treating schizophrenia and other conditions.
• Market Growth: The global Perphenazine market is expected to experience substantial growth from 2020 to 2025, driven by emerging trends and key market players.
• Market Segmentation: The market is segmented by types (oral and injectable) and applications (psychosis and antiemetic uses), with a global outreach across various regions.
• Challenges and Opportunities: While the market faces challenges related to side effects, ongoing research and the drug's broad therapeutic applications present opportunities for growth.

FAQs

What is the primary mechanism of action of Perphenazine?

Perphenazine primarily targets the D2 receptor, modulating its activity to provide therapeutic benefits for conditions such as schizophrenia, Meniere Disease, and nausea and vomiting[3].

What are the key therapeutic uses of Perphenazine?

Perphenazine is used to treat schizophrenia, Meniere Disease, postoperative nausea and vomiting, and other forms of vomiting. It is also used in combination with other drugs to manage anxiety and depressive disorders[3][4].

What is the CATIE schizophrenia trial, and how does it relate to Perphenazine?

The CATIE schizophrenia trial is a clinical trial that evaluated the effectiveness of antipsychotic drugs, including Perphenazine, in real-world clinical settings. The trial compared Perphenazine with second-generation antipsychotics and allowed for subsequent treatments if the initial medication was not effective[1].

Which regions are significant contributors to the global Perphenazine market?

North America, Europe, and the Asia-Pacific region are significant contributors to the global Perphenazine market, with countries like the United States, Canada, Germany, France, China, Japan, and India playing crucial roles[2][5].

What are the projected growth and revenue for the Perphenazine market by 2025?

The Perphenazine market is forecasted to reach significant growth by 2025, with projected revenues indicating a market value of over $100 million[5].

What are the potential side effects of Perphenazine that healthcare providers need to monitor?

Healthcare providers need to monitor for side effects such as tardive dyskinesia, hematologic effects (leukopenia and neutropenia), and hepatic effects (cholestatic jaundice or liver damage)[4].

Sources

1. National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) program: Academic.oup.com
2. Global Perphenazine Market to Experience Significant Growth during the Forecast Period 2020-2025: Pharmiweb.com
3. Perphenazine: Detailed Review of its Transformative R&D Success, Mechanism of Action, and Drug Target: Synapse.patsnap.com
4. Perphenazine Monograph for Professionals: Drugs.com
5. Perphenazine Market Expected to Reach Tremendous Growth by 2025: Openpr.com