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Article ; Online: The Essential Parallels Between Clinical Practice and the Scientific Method.

Preskorn, Sheldon H

2024 Volume 30, Issue 1, Page(s) 43–45

Abstract: This column presents a way of conceptualizing the clinical practice of medicine including psychiatry within the framework of the scientific method. The goal is to aid practicing clinicians as well as trainees. This conceptual framework will improve the ... ...

Abstract	This column presents a way of conceptualizing the clinical practice of medicine including psychiatry within the framework of the scientific method. The goal is to aid practicing clinicians as well as trainees. This conceptual framework will improve the care of patients as it applies a discipline relative to giving time-limited trials of the various treatments available and then an assessment of whether the treatment worked adequately or not and what to do in the latter case. In this way, this approach should decrease the risk of excessive multiple medication use to treat a specific patient. Incorporating this conceptual framework early in the training of mental health care prescribers would be desirable.
MeSH term(s)	Humans ; Psychiatry ; Motivation
Language	English
Publishing date	2024-01-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2022726-7
ISSN	1538-1145 ; 1527-4160
ISSN (online)	1538-1145
ISSN	1527-4160
DOI	10.1097/PRA.0000000000000759
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: How the Food and Drug Administration Drug Approval Process Relates to the Potential Approval of Intravenous Racemic Ketamine for Treatment-resistant Major Depression.

Preskorn, Sheldon H

Journal of psychiatric practice

2024 Volume 30, Issue 2, Page(s) 134–138

Abstract: This column focuses on the status of intravenous racemic ketamine for the treatment of patients suffering from a form of major depressive disorder that does not respond to trials of currently available biogenic amine antidepressants. To provide context, ... ...

Abstract	This column focuses on the status of intravenous racemic ketamine for the treatment of patients suffering from a form of major depressive disorder that does not respond to trials of currently available biogenic amine antidepressants. To provide context, the column reviews the 3 pivotal elements of the usual Food and Drug Administration (FDA) drug approval process: (1) the unmet medical need (ie, the indication) for which the drug is being developed, (2) the efficacy of the drug for that condition, and (3) the safety/tolerability of the drug. This column is based on the author's 45-year history of drug development work and is not a statement of the FDA. There are typically 3 phases in the drug development process: (1) studies done in normal volunteers, (2) typically small-scale proof of concept studies, and (3) large-scale registration trials. This third phase is critical in determining the efficacy, safety, and tolerability of the drug in a manner that most closely follows the clinical use of the drug. This column focuses specifically on whether generally small-scale studies done in academic centers are sufficient for drug approval, and it briefly reviews lithium and clozapine as examples of psychiatric medications that had such academic research in the literature, as well as clinical use in other countries. Those data supported the unique value of these medications in patients with bipolar disorder and treatment-resistant schizophrenia (ie, the unmet medical need), respectively, and the findings led American psychiatrists to advocate for FDA approval of these medications. Their efforts led to the needed registration trials for FDA approval of these medications. This column reviews the key features of registration trials and the reason that they are critical for FDA approval, and it discusses 2 special considerations related to the intravenous administration of racemic ketamine. First, racemic ketamine is not esketamine but, instead, it contains R-ketamine in addition to S-ketamine (ie, esketamine). The second consideration is that differences between intravenous and intranasal administration may affect the safety of the drug. While safety concerns were specifically addressed in the registration trials for esketamine, comparable research remains to be done for intravenous racemic ketamine. Understanding how the FDA's drug approval process works is important for prescribers, their patients, and the public.
MeSH term(s)	Humans ; Drug Approval ; Depressive Disorder, Major/drug therapy ; Ketamine/adverse effects ; Depression ; Administration, Intravenous
Chemical Substances	Esketamine (50LFG02TXD) ; Ketamine (690G0D6V8H)
Language	English
Publishing date	2024-03-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2022726-7
ISSN	1538-1145 ; 1527-4160
ISSN (online)	1538-1145
ISSN	1527-4160
DOI	10.1097/PRA.0000000000000768
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Eight Clinical Cases and the Lessons They Taught.

Preskorn, Sheldon H

Journal of psychiatric practice

2023 Volume 29, Issue 5, Page(s) 373–377

Abstract: Eight different cases are presented in this column, along with the lessons and principles that can be learned from each. The lessons and principles are general in nature and hence they are applicable to patients that readers will likely encounter. ...

Abstract	Eight different cases are presented in this column, along with the lessons and principles that can be learned from each. The lessons and principles are general in nature and hence they are applicable to patients that readers will likely encounter.
MeSH term(s)	Humans ; Learning ; Psychiatry
Language	English
Publishing date	2023-09-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2022726-7
ISSN	1538-1145 ; 1527-4160
ISSN (online)	1538-1145
ISSN	1527-4160
DOI	10.1097/PRA.0000000000000736
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Article ; Online: Comparative Pharmacology of the 3 Marketed Dual Orexin Antagonists-Daridorexant, Lemborexant, and Suvorexant-Part 2. Principal Drug Metabolizing Enzyme, Drug-Drug Interactions, and Effects of Liver and Renal Impairment on Metabolism.

Preskorn, Sheldon H

Journal of psychiatric practice

2023 Volume 29, Issue 1, Page(s) 38–41

Abstract: This column is the second in a 2-part series presenting the comparative pharmacology of the 3 Food and Drug Administration-approved dual orexin receptor antagonists, daridorexant, lemborexant, and suvorexant. Both of the columns in this series emphasize ... ...

Abstract	This column is the second in a 2-part series presenting the comparative pharmacology of the 3 Food and Drug Administration-approved dual orexin receptor antagonists, daridorexant, lemborexant, and suvorexant. Both of the columns in this series emphasize the pharmacokinetics of these drugs as they are relevant to their use as sleep medications. Although other classes of sleep medications are not discussed, the same pharmacokinetic principles also apply to them in terms of endeavoring to match the pharmacokinetics of an agent to the individual's usual sleep cycle. This second column in the series focuses on the metabolism of each of the 3 drugs by the cytochrome P450 enzyme CYP3A, guidance for using these agents in combination with drugs that are CYP3A inhibitors or inducers, and how to adjust dosing in patients with comorbid conditions such as hepatic or renal impairment.
MeSH term(s)	Humans ; Pharmaceutical Preparations ; Orexins ; Orexin Receptor Antagonists/pharmacokinetics ; Drug Interactions ; Liver ; Sleep Initiation and Maintenance Disorders/drug therapy
Chemical Substances	suvorexant (081L192FO9) ; lemborexant (0K5743G68X) ; daridorexant ; Pharmaceutical Preparations ; Orexins ; Orexin Receptor Antagonists
Language	English
Publishing date	2023-01-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2022726-7
ISSN	1538-1145 ; 1527-4160
ISSN (online)	1538-1145
ISSN	1527-4160
DOI	10.1097/PRA.0000000000000690
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Article ; Online: Seven Mechanistically Different Classes of Medications Can Be Used to Treat Insomnia and Related Sleep Disorders.

Preskorn, Sheldon H

Journal of psychiatric practice

2023 Volume 29, Issue 3, Page(s) 227–234

Abstract: This column reviews the neurobiology of the sleep-wake cycle as it is currently known, the 7 classes of currently available sleep-enhancing medications, and how their mechanisms of action relate to the neurobiology of sleep. Clinicians can use this ... ...

Abstract	This column reviews the neurobiology of the sleep-wake cycle as it is currently known, the 7 classes of currently available sleep-enhancing medications, and how their mechanisms of action relate to the neurobiology of sleep. Clinicians can use this information to select medications for their patients, which is particularly important because some patients respond to some of these medications but not others, or tolerate some but not others. This knowledge can also help the clinician switch among classes when a medication that was initially efficacious begins to fail a patient. It can also prevent the clinician from cycling through all of the members of a single medication class. Such a strategy is unlikely to be helpful for a patient except in the situation in which pharmacokinetic differences among members of the medication class result in some agents in that class being helpful for a patient who has either a delayed onset of action or undesirable carry-over effects with other agents in that class. An understanding of the classes of sleep-enhancing medications highlights the importance of knowing the neurobiology that underlies a psychiatric illness. The activity of a number of neurobiological circuits, such as the one reviewed in this column, has now been well established, while work to understand others is still at a much earlier stage. Psychiatrists who gain an understanding of such circuits will be better able to provide effective care for their patients.
MeSH term(s)	Humans ; Sleep Initiation and Maintenance Disorders/drug therapy ; Sleep ; Sleep Wake Disorders/drug therapy
Language	English
Publishing date	2023-05-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2022726-7
ISSN	1538-1145 ; 1527-4160
ISSN (online)	1538-1145
ISSN	1527-4160
DOI	10.1097/PRA.0000000000000709
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Article: Drug Development in Psychiatry: The Long and Winding Road from Chance Discovery to Rational Development.

Preskorn, Sheldon H

Advances in neurobiology

2023 Volume 30, Page(s) 1–18

Abstract: Based extensively on tables and figures, this chapter reviews drug development in psychiatry with an emphasis on antidepressants from the 1950s to the present and then looks forward to the future. It begins with the chance discovery drugs and then moves ... ...

Abstract	Based extensively on tables and figures, this chapter reviews drug development in psychiatry with an emphasis on antidepressants from the 1950s to the present and then looks forward to the future. It begins with the chance discovery drugs and then moves to through their rational refinement using structure activity relationships to narrow the pharmacological actions of the drugs to those mediating their antidepressant effects and eliminating the effects on targets that mediate adverse effects. This approach yielded newer antidepressants which compared to older antidepressants are safer and better tolerated but nevertheless do still not treat the approximately 40% of patients with major depression (MD) which is unresponsive to biogenic amine mechanisms of action. This form of MD is commonly referred to as treatment resistant depression. Esketamine is an antidepressant which has a novel mechanism of action: blockade of the glutamate NMDA receptor. These studies coupled with earlier studies with other NMDA drugs suggest approximately 60% of patient with TRD are rapidly and robustly responsive to this mechanism of action. Thus, there appears to be three forms of MD based on pharmacological responsiveness: (a) 60% responsive to biogenic amine mechanisms of action, (b) 24% (i.e., 40 × 60%) responsive to NMDA but not to biogenic amine mechanisms of action, and (c) 16% (i.e., 40-24%) not responsive to either of these mechanisms of action. Scientific investigation of these three groups may yield important information about the pathophysiology and/or pathoetiology of these different forms of MD. This information coupled with studies into the neurobiology (e.g., imaging studies, connectomes to name a few approaches being used) and genetics of MD should provide the fundamental knowledge which will permit a rational search for and discovery of newer antidepressant drugs and other somatic and psychotherapeutic approaches to the treatment of patients with different forms of MD based on pathophysiology and pathoetiology. Examples are given of how such discovery and development have occurred in other areas of medicine and even in central nervous system (CNS) space including six novel mechanisms of action CNS drugs which have been successfully developed and marketed over the last 25 years.
MeSH term(s)	Humans ; N-Methylaspartate ; Antidepressive Agents/therapeutic use ; Drug Development ; Receptors, Glutamate ; Psychiatry ; Biogenic Amines
Chemical Substances	N-Methylaspartate (6384-92-5) ; Antidepressive Agents ; Receptors, Glutamate ; Biogenic Amines
Language	English
Publishing date	2023-03-16
Publishing country	United States
Document type	Journal Article
ISSN	2190-5215
ISSN	2190-5215
DOI	10.1007/978-3-031-21054-9_1
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: An Individual With 2 Distinct Nonpathologic Identities.

Preskorn, Sheldon H

Journal of psychiatric practice

2022 Volume 28, Issue 1, Page(s) 48–49

Abstract: This article presents the case of a Vietnamese-American medical student who had 2 distinct identities which were not due to a pathologic process but rather were the result of learning. This case illustrates the complexity of brain function which is ... ...

Abstract	This article presents the case of a Vietnamese-American medical student who had 2 distinct identities which were not due to a pathologic process but rather were the result of learning. This case illustrates the complexity of brain function which is fundamental to psychiatry.
MeSH term(s)	Humans ; Learning ; Psychiatry ; Self Concept
Language	English
Publishing date	2022-01-06
Publishing country	United States
Document type	Case Reports ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2022726-7
ISSN	1538-1145 ; 1527-4160
ISSN (online)	1538-1145
ISSN	1527-4160
DOI	10.1097/PRA.0000000000000600
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Article ; Online: Comparative Pharmacology of the 3 Marketed Dual Orexin Antagonists-Daridorexant, Lemborexant, and Suvorexant: Part 1: Pharmacokinetic Profiles.

Preskorn, Sheldon H

Journal of psychiatric practice

2022 Volume 28, Issue 6, Page(s) 478–480

Abstract: This first column in a 2-part series focuses on the pharmacokinetics of the 3 Food and Drug Administration-approved dual orexin receptor antagonists, daridorexant, lemborexant, and suvorexant, specifically as they relate to their use as sleep medications. ...

Abstract	This first column in a 2-part series focuses on the pharmacokinetics of the 3 Food and Drug Administration-approved dual orexin receptor antagonists, daridorexant, lemborexant, and suvorexant, specifically as they relate to their use as sleep medications. Although other classes of sleep medications are not discussed, the same pharmacokinetic principles also apply to them.
MeSH term(s)	Humans ; Orexins ; Azepines/pharmacology ; Sleep Initiation and Maintenance Disorders/drug therapy
Chemical Substances	suvorexant (081L192FO9) ; lemborexant (0K5743G68X) ; daridorexant ; Orexins ; Azepines
Language	English
Publishing date	2022-11-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2022726-7
ISSN	1538-1145 ; 1527-4160
ISSN (online)	1538-1145
ISSN	1527-4160
DOI	10.1097/PRA.0000000000000672
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Article ; Online: How Loading Dose Strategies for Depot Paliperidone Can Go Wrong.

Preskorn, Sheldon H

Journal of psychiatric practice

2022 Volume 28, Issue 2, Page(s) 130–137

Abstract: This column presents a real-life case of a patient who developed severe and prolonged Parkinsonism secondary to the loading dose strategy recommended in the prescribing information (package insert) for paliperidone palmitate (Invega Sustenna). This ... ...

Abstract	This column presents a real-life case of a patient who developed severe and prolonged Parkinsonism secondary to the loading dose strategy recommended in the prescribing information (package insert) for paliperidone palmitate (Invega Sustenna). This column presents 2 major points. First, the case illustrates what the practitioner must do before following the general guidelines for a loading dose approach to the administration of paliperidone palmitate as outlined in the package insert to decrease the likelihood of a serious and potentially fatal consequence. Second, the case illustrates how therapeutic drug monitoring can be useful in assessing and managing patients who develop an untoward reaction. In this case, therapeutic drug monitoring was done using serum prolactin levels because the available laboratory could not measure the level of the drug itself in plasma, and the case highlights some limitations to keep in mind when using plasma prolactin levels to do such monitoring. To put this case in context, a review of the literature was conducted which identified 3 related cases. The author also refers readers to previous articles on therapeutic drug monitoring and pharmacokinetic considerations that arise when using depot (long-acting injectable) antipsychotics.
MeSH term(s)	Antipsychotic Agents/therapeutic use ; Humans ; Paliperidone Palmitate/therapeutic use ; Prolactin/therapeutic use ; Schizophrenia/drug therapy
Chemical Substances	Antipsychotic Agents ; Prolactin (9002-62-4) ; Paliperidone Palmitate (R8P8USM8FR)
Language	English
Publishing date	2022-03-03
Publishing country	United States
Document type	Case Reports ; Journal Article ; Review
ZDB-ID	2022726-7
ISSN	1538-1145 ; 1527-4160
ISSN (online)	1538-1145
ISSN	1527-4160
DOI	10.1097/PRA.0000000000000615
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Article ; Online: How an Understanding of the Function of the Locus Coeruleus Led to Use of Dexmedetomidine to Treat Agitation in Bipolar Disorder: Example of Rational Development of Psychiatric Medications.

Preskorn, Sheldon H

Journal of psychiatric practice

2022 Volume 28, Issue 3, Page(s) 227–233

Abstract: This column reviews >50 years of research on the functions subsumed by the locus coeruleus (LC) (also called the central adrenergic system). A major role of the LC is monitoring acid-base balance in the brain and responding by regulating blood-brain ... ...

Abstract	This column reviews >50 years of research on the functions subsumed by the locus coeruleus (LC) (also called the central adrenergic system). A major role of the LC is monitoring acid-base balance in the brain and responding by regulating blood-brain permeability to water and other small molecules and cerebral blood flow. The LC, through its downward projections, also regulates and coordinates respiratory and cardiac functions. Through its effect regionally or more globally depending on the stimulus and its magnitude, the LC can regulate the extracellular space in the brain, which in turn can alter ionic concentrations and thus the sensitivity of neurons to signaling. As a result of these far-reaching effects, the LC has been implicated in brain functions ranging from sleep and wakefulness to psychiatric conditions such as hyperarousal/hypervigilance, fear, agitation, anxiety, and panic attacks. This understanding of the brain functions subsumed by the LC has, in turn, led to the most recent development in the use of dexmedetomidine, an alpha-2 adrenergic agonist, to treat agitation in patients with bipolar disorder. This column also illustrates a theme discussed in a series of previous columns concerning the successful development of novel psychiatric/central nervous system drugs on the basis of an understanding of relatively simple circuits or mechanisms that underlie pathologic behavior.
MeSH term(s)	Adrenergic alpha-2 Receptor Agonists/pharmacology ; Anxiety ; Bipolar Disorder/drug therapy ; Dexmedetomidine/pharmacology ; Dexmedetomidine/therapeutic use ; Humans ; Locus Coeruleus/physiology
Chemical Substances	Adrenergic alpha-2 Receptor Agonists ; Dexmedetomidine (67VB76HONO)
Language	English
Publishing date	2022-05-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2022726-7
ISSN	1538-1145 ; 1527-4160
ISSN (online)	1538-1145
ISSN	1527-4160
DOI	10.1097/PRA.0000000000000634
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