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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR KETALAR

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Clinical Trials for Ketalar

Trial ID Title Status Sponsor Phase Summary
NCT00129597 Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy Unknown status Hospices Civils de Lyon Phase 4 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 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 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ketalar

Condition Name

Condition Name for Ketalar
Intervention Trials
Pain 9
Depression 9
Major Depressive Disorder 8
Anesthesia 5
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Condition MeSH

Condition MeSH for Ketalar
Intervention Trials
Depression 27
Depressive Disorder 26
Depressive Disorder, Major 14
Pain, Postoperative 8
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Clinical Trial Locations for Ketalar

Trials by Country

Trials by Country for Ketalar
Location Trials
United States 58
Canada 7
Israel 6
United Kingdom 4
Turkey 4
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Trials by US State

Trials by US State for Ketalar
Location Trials
New York 12
California 6
Missouri 6
Minnesota 5
Ohio 4
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Clinical Trial Progress for Ketalar

Clinical Trial Phase

Clinical Trial Phase for Ketalar
Clinical Trial Phase Trials
Phase 4 40
Phase 3 6
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Ketalar
Clinical Trial Phase Trials
Recruiting 42
Completed 26
Not yet recruiting 11
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Clinical Trial Sponsors for Ketalar

Sponsor Name

Sponsor Name for Ketalar
Sponsor Trials
Mayo Clinic 5
Washington University School of Medicine 5
National Alliance for Research on Schizophrenia and Depression 3
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Sponsor Type

Sponsor Type for Ketalar
Sponsor Trials
Other 150
Industry 4
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Deloitte
US Army
McKesson
McKinsey
Cerilliant
Julphar
UBS
US Department of Justice

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