CLINICAL TRIALS PROFILE FOR THIOTHIXENE HYDROCHLORIDE

All Clinical Trials for thiothixene hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03158805 ↗	Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)	Recruiting	Lindner Center of HOPE	Phase 2	2017-04-26	Taken together these data support the hypothesis that liraglutide 3.0 mg sc injection will reduce body weight and improve metabolic variables in obese or overweight patients with BP without worsening psychiatric symptoms. The investigators predict that liraglutide 3.0 mg sc injection will display greater efficacy as compared to placebo in decreasing body weight in patients with BP who are obese or overweight. To prove this hypothesis, investigators will conduct a single-center, randomized, placebo-controlled, double-blind, parallel-group, 2-arm clinical trial of liraglutide 3.0 mg sc injection in 60 obese or overweight outpatients with stable BP. The investigators have chosen BP rather than another SMI because it is the most common SMI (more common than schizophrenia or schizoaffective disorder) and has a particularly strong association with obesity.
NCT02600741 ↗	Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)	Completed	Janssen Scientific Affairs, LLC		2015-07-24	The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.
NCT02582736 ↗	Antipsychotics and Risk of Hyperglycemic Emergencies	Completed	Canadian Institutes of Health Research (CIHR)		2012-04-01	The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency. The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.
NCT02582736 ↗	Antipsychotics and Risk of Hyperglycemic Emergencies	Completed	Drug Safety and Effectiveness Network, Canada		2012-04-01	The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency. The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.
NCT02582736 ↗	Antipsychotics and Risk of Hyperglycemic Emergencies	Completed	Canadian Network for Observational Drug Effect Studies, CNODES		2012-04-01	The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency. The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.
NCT01234454 ↗	Atypical Antipsychotic Treatment Effect On Brain Function In Schizophrenia Measured By FMRI	Completed	University of North Carolina, Chapel Hill	N/A	2002-01-01	The general aim is to compare the effects of typical and atypical antipsychotic medication on brain structure and function. A parallel group treatment trial will be utilized to compare the effects of the typical antipsychotic thiothixene versus the atypical antipsychotics risperidone (RIS) and olanzapine (OLZ) on brain structure and function in schizophrenia in an effort to determine the neuroanatomic basis for cognitive pathology in schizophrenia and its amelioration by atypical antipsychotic drugs.

Clinical Trial Conditions for thiothixene hydrochloride

Condition Name

Condition Name for thiothixene hydrochloride
Intervention	Trials
Schizophrenia	3
Bipolar Disorder	2
Diabetes Mellitus, Type 2	1
Obesity	1

Condition MeSH

Condition MeSH for thiothixene hydrochloride
Intervention	Trials
Schizophrenia	3
Disease	2
Bipolar Disorder	2
Psychotic Disorders	1

Clinical Trial Locations for thiothixene hydrochloride

Trials by Country

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−

Trials by Country for thiothixene hydrochloride
Location	Trials
United States	24
Canada	1

Trials by US State

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−

Trials by US State for thiothixene hydrochloride
Location	Trials
Ohio	2
Washington	1
Utah	1
Texas	1
Tennessee	1

Clinical Trial Progress for thiothixene hydrochloride

Clinical Trial Phase

Clinical Trial Phase for thiothixene hydrochloride
Clinical Trial Phase	Trials
Phase 2	1
N/A	1

Clinical Trial Status

Clinical Trial Status for thiothixene hydrochloride
Clinical Trial Phase	Trials
Completed	3
Recruiting	1

Clinical Trial Sponsors for thiothixene hydrochloride

Sponsor Name

Sponsor Name for thiothixene hydrochloride
Sponsor	Trials
University of North Carolina, Chapel Hill	1
Canadian Institutes of Health Research (CIHR)	1
Drug Safety and Effectiveness Network, Canada	1

Sponsor Type

Sponsor Type for thiothixene hydrochloride
Sponsor	Trials
Other	5
Industry	1

Thiothixene Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Thiothixene Hydrochloride

Thiothixene hydrochloride, commonly known as thiothixene, is an antipsychotic medication belonging to the thioxanthene class. It is primarily used in the management of schizophrenia and has been in clinical use for several decades[3][4].

Clinical Use and Mechanism of Action

Thiothixene acts as an antagonist on various post-synaptic receptors, including dopaminergic (D1, D2, D3, and D4), serotonergic (5-HT1 and 5-HT2), histaminergic (H1), alpha1/alpha2-adrenergic, and muscarinic (M1/M2) receptors. This broad receptor antagonism contributes to its antipsychotic, anxiolytic, antidepressive, and antiaggressive properties, as well as its side effect profile[3].

Clinical Trials and Efficacy

While thiothixene has been widely used, it is less favored today compared to atypical antipsychotics due to its side effect profile. Clinical trials have shown that thiothixene can be effective in managing schizophrenia, but it often comes with significant side effects such as extrapyramidal symptoms, tardive dyskinesia, and neuroleptic malignant syndrome[2][4].

Treatment-Resistant Schizophrenia

In cases of treatment-resistant schizophrenia, where patients do not respond to two or more antipsychotics from different chemical classes, thiothixene may be considered as part of a treatment regimen. However, the first line of treatment for such cases often involves clozapine due to its superior efficacy in this patient population[2].

Side Effects and Safety

Thiothixene is associated with several serious side effects, including tardive dyskinesia, a potentially irreversible motor disorder. The risk of tardive dyskinesia is significant, although slightly lower than with first-generation antipsychotics (FGAs). Other side effects include neuroleptic malignant syndrome, dizziness, trouble with thinking, and trouble with controlling body movements[2][4].

Market Analysis

Market Size and Growth

The global market for thiothixene API is anticipated to grow significantly over the forecast period from 2023 to 2031. The market is segmented by type (above 98%, above 99%), application (capsule, tablet, injection solution, others), and geography (North America, Europe, Asia-Pacific, South America, Middle-East and Africa). Despite the rise of atypical antipsychotics, the demand for thiothixene remains due to its established use and lower cost[1].

Competitive Landscape

The market for thiothixene API is competitive, with key players such as Dideu Group, Midas Pharma GmbH, Angle Biopharma, Nuray Chemicals Pvt Ltd, and Aspen Oss. These companies are profiled based on their product offerings, financial statements, key developments, and market strategies. The competitive landscape also includes recent initiatives, collaborations, mergers and acquisitions, and new product launches[1].

Market Drivers and Restraints

The growth of the thiothixene API market is driven by the increasing incidence of mental health disorders, particularly schizophrenia. However, the market is restrained by the availability of newer, safer antipsychotic medications and the significant side effect profile associated with thiothixene. Technological innovations in antipsychotic drugs and changes in consumer behavior also influence market dynamics[1][5].

Market Projections

Forecast Period

The thiothixene API market is projected to exhibit sustained growth from 2023 to 2031. The market size is expected to increase due to the ongoing demand for antipsychotic medications and the expanding reach of these products in various geographical regions[1].

Regional Analysis

The market is segmented geographically, with North America, Europe, and Asia-Pacific being key regions. The Asia-Pacific region is expected to show significant growth due to increasing healthcare expenditure and a rising prevalence of mental health disorders[1].

Application Segments

Thiothixene API is used in various formulations, including capsules, tablets, and injection solutions. The capsule and tablet segments are expected to dominate the market due to their ease of administration and patient compliance[1].

Key Takeaways

• Clinical Efficacy: Thiothixene is effective in managing schizophrenia but is associated with significant side effects.
• Market Growth: The thiothixene API market is expected to grow significantly from 2023 to 2031 driven by increasing demand for antipsychotic medications.
• Competitive Landscape: Key players include Dideu Group, Midas Pharma GmbH, and others, with a focus on product offerings and market strategies.
• Geographical Segmentation: Asia-Pacific is expected to show significant growth due to increasing healthcare expenditure.
• Application Segments: Capsule and tablet formulations are expected to dominate the market.

FAQs

What is thiothixene hydrochloride used for?

Thiothixene hydrochloride is used primarily for the management of schizophrenia.

What are the common side effects of thiothixene?

Common side effects include extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome, dizziness, and trouble with thinking and body movements.

Is thiothixene still widely used today?

Thiothixene is less favored today compared to atypical antipsychotics due to its side effect profile, but it still maintains a market presence.

What is the projected growth of the thiothixene API market?

The market is anticipated to grow significantly from 2023 to 2031, driven by the increasing demand for antipsychotic medications.

Who are the key players in the thiothixene API market?

Key players include Dideu Group, Midas Pharma GmbH, Angle Biopharma, Nuray Chemicals Pvt Ltd, and Aspen Oss.

Sources

1. Market Research Intellect, "Thiothixene API Market Size, Scope And Forecast Report"
2. ASHP, "Therapeutic Position Statement on the Use of Antipsychotic Medications in the Treatment of Adults with Schizophrenia and Schizoaffective Disorder"
3. DrugBank, "Thiothixene: Uses, Interactions, Mechanism of Action"
4. Mayo Clinic, "Thiothixene (oral route)"
5. Business Wire, "Global Antipsychotic Drugs Market Analysis & Trends 2014-2016 - Industry Forecasts 2017-2025 - Research and Markets"