CLINICAL TRIALS PROFILE FOR KETALAR

All Clinical Trials for Ketalar

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00129597 ↗	Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy	Unknown status	Hospices Civils de Lyon	Phase 4	2004-12-01	Prevalence of chronic pain after mastectomy is beyond 50% 3 months after surgery. This pain is related to a sensitization of the central nervous system through N-methyl-D-asparate (NMDA) receptors. Ketalar might prevent the occurrence of chronic pain by anti-NMDA properties after mastectomy.
NCT00205712 ↗	Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 4	2003-02-01	Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00205712 ↗	Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids	Completed	Washington University School of Medicine	Phase 4	2003-02-01	Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00252122 ↗	Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease	Terminated	Children's Hospital of Philadelphia	Phase 4	2004-06-01	The purpose of this pilot study is to provide a preliminary assessment of the feasibility and efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease (who are admitted to the hospital with severe, acute pain crisis, and who have been resistant to intravenous narcotics).
NCT00419003 ↗	Research Study for Major Depressive Disorder: Investigation of Glutamate Medications	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 4	2006-12-01	This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.
NCT00419003 ↗	Research Study for Major Depressive Disorder: Investigation of Glutamate Medications	Completed	National Center for Research Resources (NCRR)	Phase 4	2006-12-01	This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.
NCT00419003 ↗	Research Study for Major Depressive Disorder: Investigation of Glutamate Medications	Completed	Baylor College of Medicine	Phase 4	2006-12-01	This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.

Clinical Trial Conditions for Ketalar

Condition Name

Condition Name for Ketalar
Intervention	Trials
Depression	13
Pain	12
Major Depressive Disorder	10
Anesthesia	7

Condition MeSH

Condition MeSH for Ketalar
Intervention	Trials
Depression	39
Depressive Disorder	35
Depressive Disorder, Major	17
Pain, Postoperative	13

Clinical Trial Locations for Ketalar

Trials by Country

Trials by Country for Ketalar
Location	Trials
United States	103
Egypt	12
Canada	10
Turkey	6
Israel	6

Trials by US State

Trials by US State for Ketalar
Location	Trials
California	15
New York	13
Pennsylvania	8
Ohio	7
Missouri	7

Clinical Trial Progress for Ketalar

Clinical Trial Phase

Clinical Trial Phase for Ketalar
Clinical Trial Phase	Trials
Phase 4	53
Phase 3	14
Phase 2/Phase 3	11

Clinical Trial Status

Clinical Trial Status for Ketalar
Clinical Trial Phase	Trials
Completed	78
Recruiting	18
Not yet recruiting	16

Clinical Trial Sponsors for Ketalar

Sponsor Name

Sponsor Name for Ketalar
Sponsor	Trials
Mayo Clinic	7
Assiut University	6
Washington University School of Medicine	6

Sponsor Type

Sponsor Type for Ketalar
Sponsor	Trials
Other	236
NIH	10
Industry	6

Ketalar (Ketamine): Clinical Trials, Market Analysis, and Projections

Introduction to Ketalar (Ketamine)

Ketalar, commonly known as ketamine, is a medication that has been increasingly recognized for its therapeutic potential beyond its traditional use as an anesthetic. Recent years have seen a surge in research and clinical trials exploring its efficacy in treating various mental health disorders and other conditions.

Clinical Trials Update

The Bio-K Study

The Bio-K study, conducted by the University of Michigan, is a significant clinical trial focused on using ketamine to treat depression in individuals with major depressive disorder, bipolar I, or bipolar II disorder. This study aims to identify biomarkers that can predict the response to ketamine treatment in patients with treatment-resistant depression. The trial involves multiple IV ketamine infusions and comprehensive assessments, including blood draws, ECG, urine tests, and clinical evaluations. Although the study is no longer recruiting participants, it represents a crucial effort in understanding the efficacy and predictive markers for ketamine treatment in depression[1].

Comparative Effectiveness Trial: ECT vs. Ketamine

A recent study led by investigators from Mass General Brigham compared the effectiveness of subanesthetic intravenous ketamine with electroconvulsive therapy (ECT) for treating non-psychotic treatment-resistant major depression. The trial, which involved 403 patients, found that ketamine was not inferior to ECT in improving depressive symptoms and quality of life, with fewer side effects. This study highlights ketamine as a viable alternative to ECT for patients who do not respond to conventional treatments[4].

MIRA Pharmaceuticals' Ketamir-2 Trial

MIRA Pharmaceuticals is conducting a Phase I/IIa clinical trial for Ketamir-2, a novel oral ketamine analog. The trial, set to begin in Q1 2025, will utilize the Centre for Human Drug Research's (CHDR) PainCart technology to measure pain response in healthy subjects and later in diabetic neuropathy patients. This study is designed to evaluate the safety, tolerability, and efficacy of Ketamir-2, which has shown promising preclinical results compared to existing pain medications like pregabalin and gabapentin[3].

Market Analysis

U.S. Ketamine Clinics Market

The U.S. ketamine clinics market has experienced significant growth, driven by the increasing recognition of ketamine's therapeutic potential in treating mental health disorders such as depression, anxiety, and PTSD. As of 2023, the market size was estimated at USD 3.41 billion and is projected to grow at a CAGR of 10.60% from 2024 to 2030, reaching USD 6.90 billion by 2030. The depression segment dominated the market in 2023, accounting for 30.15% of the total market share[2].

Key Drivers and Trends

• Increasing Use of Ketamine: The expanding use of ketamine for various therapies is a major driver of market growth.
• Growing Number of Clinics: Hundreds of ketamine clinics have emerged across the U.S., reflecting the growing acceptance of ketamine as a valuable mental health treatment.
• Telehealth and Online Therapy: The COVID-19 pandemic has accelerated the growth of online therapy segments, making ketamine treatments more accessible and convenient.
• Investments and Partnerships: Significant investments and partnerships among key players are driving market growth and increasing competition[2].

Key Players

The U.S. ketamine clinics market is characterized by several key players, including NY Ketamine Infusions, Field Trip Health, Ketamine Clinics Los Angeles, Klarity Clinic, Vitalitas Denver Ketamine Clinic, Mindbloom, Inc., Nue Life Health, and Innerwell. These companies are involved in various strategies such as partnerships, acquisitions, and the launch of new services to expand their market share[2].

Market Projections

Growth Forecast

The U.S. ketamine clinics market is expected to continue its robust growth, driven by the increasing demand for ketamine treatments and the expansion of telehealth services. By 2030, the market is projected to reach USD 6.90 billion, with a CAGR of 10.60% from 2024 to 2030[2].

Segment Outlook

• Depression Segment: This segment is expected to remain dominant, given the high prevalence of major depressive disorder and the efficacy of ketamine in treating treatment-resistant depression.
• Online Therapy Segment: This segment is anticipated to grow at the fastest rate, driven by the rise of telehealth and remote healthcare services[2].

Future Directions

Ongoing Research and Development

Ongoing preclinical and clinical studies, such as those by MIRA Pharmaceuticals, are exploring new ketamine analogs and their potential in treating various conditions, including pain management and PTSD. These studies are crucial for expanding the therapeutic applications of ketamine and its derivatives[3].

Regulatory and Clinical Milestones

The approval of new ketamine-based treatments and the completion of clinical trials will be key milestones in the future. For instance, MIRA Pharmaceuticals' Phase I/IIa trial for Ketamir-2 is expected to provide significant insights into the safety and efficacy of this novel oral ketamine analog by 2026[3].

Key Takeaways

• Clinical Trials: Ongoing and completed trials, such as the Bio-K study and the ECT vs. ketamine trial, highlight ketamine's efficacy in treating depression and other mental health disorders.
• Market Growth: The U.S. ketamine clinics market is expected to grow significantly, driven by increasing demand and the expansion of telehealth services.
• Key Players: Companies like NY Ketamine Infusions, Field Trip Health, and Innerwell are driving market growth through investments, partnerships, and new service launches.
• Future Directions: Ongoing research and development, particularly in new ketamine analogs, are expected to further expand the therapeutic applications of ketamine.

FAQs

Q: What is the primary focus of the Bio-K study?

A: The Bio-K study aims to determine if ketamine can help symptoms of depression in people with major depressive disorder, bipolar I, or bipolar II disorder, and to identify biomarkers that predict the response to ketamine treatment[1].

Q: How does ketamine compare to ECT in treating depression?

A: A recent study found that subanesthetic intravenous ketamine was not inferior to ECT in improving depressive symptoms and quality of life, with fewer side effects associated with ketamine[4].

Q: What is Ketamir-2, and what is its current status in clinical trials?

A: Ketamir-2 is a novel oral ketamine analog being developed by MIRA Pharmaceuticals. The Phase I/IIa clinical trial is set to begin in Q1 2025 and will evaluate its safety, tolerability, and efficacy in healthy subjects and diabetic neuropathy patients[3].

Q: What is the projected growth rate of the U.S. ketamine clinics market?

A: The U.S. ketamine clinics market is expected to grow at a CAGR of 10.60% from 2024 to 2030, reaching USD 6.90 billion by 2030[2].

Q: Which segment is expected to grow the fastest in the U.S. ketamine clinics market?

A: The online therapy segment is expected to grow at the fastest rate, driven by the rise of telehealth and remote healthcare services[2].

Sources

1. The Bio-K Study: Biomarker Development Ketamine Clinical Trial for Unipolar and Bipolar I or II Depression. University of Michigan.
2. U.S. Ketamine Clinics Market Size | Industry Report, 2030. Grand View Research.
3. MIRA Pharmaceuticals Advances Novel Ketamine Drug Trial. Stock Titan.
4. Study Finds Ketamine Is at Least as Effective as ECT for Treating Major Depression. Brigham and Women's Hospital.
5. Ketamine Global Market Insights (2020 to 2025) - Analysis. GlobeNewswire.