Seizure Incidence in Psychopharmacological Clinical Trials: An Analysis of Food and Drug Administration (FDA) Summary Basis of Approval Reports

Alper, Kenneth; Schwartz, Kelly A.; Kolts, Russell L.; Khan, Arif

doi:10.1016/j.biopsych.2006.09.023

Cited by 462 publications

(287 citation statements)

References 120 publications

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“…The lack of clinical trial information, compounded by evidence of the impact of antipsychotics on seizure frequency, leads to considerable clinical equipoise 39. The clinician in epilepsy should consider that no drug is often the best drug for this group of patients.…”

Section: Pharmacological Treatments Of Behavioral Disordermentioning

confidence: 99%

Behavioral disorder in people with an intellectual disability and epilepsy: A report of the Intellectual Disability Task Force of the Neuropsychiatric Commission of ILAE

et al. 2016

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SummaryThe management and needs of people with intellectual disability (ID) and epilepsy are well evidenced; less so, the comorbidity of behavioral disorder in this population. “Behavioral disorder” is defined as behaviors that are difficult or disruptive, including stereotypes, difficult or disruptive behavior, aggressive behavior toward other people, behaviors that lead to injury to self or others, and destruction of property. These have an important link to emotional disturbance. This report, produced by the Intellectual Disability Task Force of the Neuropsychiatric Commission of the ILAE, aims to provide a brief review of some key areas of concern regarding behavioral disorder among this population and proposes a range of research and clinical practice recommendations generated by task force members. The areas covered in this report were identified by experts in the field as being of specific relevance to the broad epilepsy community when considering behavioral disorder in persons with epilepsy and ID; they are not intended to be exhaustive. The practice recommendations are based on the authors’ review of the limited research in this field combined with their experience supporting this population. These points are not graded but can be seen as expert opinion guiding future research and clinical practice.

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Section: Pharmacological Treatments Of Behavioral Disordermentioning

confidence: 99%

Behavioral disorder in people with an intellectual disability and epilepsy: A report of the Intellectual Disability Task Force of the Neuropsychiatric Commission of ILAE

et al. 2016

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“…However, it has to be acknowledge that this has been demonstrated mainly for clozapine while all other antipsychotics, especially SGAP, seem to have a low proconvulsant risk (48). For clozapine the risk seems to be both titration-and dose-dependent.…”

Section: Effect Of Antipsychotics On Seizure Thresholdmentioning

confidence: 99%

The pharmacological management of psychiatric comorbidities in patients with epilepsy

Mula

2016

Pharmacological Research

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Psychiatric disorders represent a frequent comorbidity in patients with epilepsy affecting quality of life, morbidity and mortality. Evidence-based data on the management of these conditions are limited but a number of recommendations are now available to guide clinical practice. The present paper reviews the pharmacological treatment of psychiatric problems in epilepsy with special attention to data coming from randomised controlled trials (RCTs), pharmacological interactions with AEDs and the issue of seizure worsening during treatment with psychotropic drugs. Epidemiologically or clinically relevant psychiatric conditions are discussed namely mood and anxiety disorders, psychoses and attention deficit hyperactivity disorder.

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“…Data from one study appear to dispel this concern with respect to the antidepressant drugs. Indeed, Alper et al [8] looked at the incidence of seizures experienced by patients with primary MDD randomized to an antidepressant or placebo in the course of multicenter, randomized,placebo-controlled trials of selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors submitted to the Food and Drug Administration for regulatory purposes. They found that a higher incidence of epileptic seizures was identified among depressed patients randomized to placebo than to the antidepressant drug (standardized incidence ratio=0.48; 95 % CI 0.36-0.61).…”

Section: Epidemiologic Datamentioning

confidence: 99%

“…However, an iatrogenic process cannot be completely discounted in patients with psychotic disorders, as a higher incidence of seizures was identified among patients randomized to clozapine, followed by olanzapine and to a lesser degree, quetiapine than to placebo in the same study [8]. A predisposition to the development of seizures mediated by the psychotic process coupled with an iatrogenic effect of antipsychotic drugs may also be a possibility.…”

Section: Epidemiologic Datamentioning

confidence: 99%

Biomarkers of Epileptogenesis: Psychiatric Comorbidities (?)

Kanner

Mazarati

Koepp³

2014

Neurotherapeutics

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The last decade has witnessed a significant shift on our understanding of the relationship between psychiatric disorders and epilepsy. While traditionally psychiatric disorders were considered as a complication of the underlying seizure disorder, new epidemiologic data, supported by clinical and experimental research, have suggested the existence of a bidirectional relation between the two types of conditions: not only are patients with epilepsy at greater risk of experiencing a psychiatric disorder, but patients with primary psychiatric disorders are at greater risk of developing epilepsy. Do these data suggest that some of the pathogenic mechanisms operant in psychiatric comorbidities play a role in epileptogenesis? The aim of this article is to review the epidemiologic data that demonstrate that primary psychiatric disorders are more frequent in people who develop epilepsy, before the onset of the seizure disorder than among controls. The next question looks at the available data of pathogenic mechanisms of primary mood disorders and their potential for facilitating the development and/or exacerbation in the severity of epileptic seizures. Finally, we review data derived from experimental studies in animal models of depression and epilepsy that support a potential role of pathogenic mechanisms of mood disorders in the development of epileptic seizures and epileptogenesis. The data presented in this article do not yet establish conclusive evidence of a pathogenic role of psychiatric comorbidities in epileptogenesis, but raise important research questions that need to be investigated in experimental, clinical, and population-based epidemiologic research studies.

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Seizure Incidence in Psychopharmacological Clinical Trials: An Analysis of Food and Drug Administration (FDA) Summary Basis of Approval Reports

Cited by 462 publications

References 120 publications

Behavioral disorder in people with an intellectual disability and epilepsy: A report of the Intellectual Disability Task Force of the Neuropsychiatric Commission of ILAE

Behavioral disorder in people with an intellectual disability and epilepsy: A report of the Intellectual Disability Task Force of the Neuropsychiatric Commission of ILAE

The pharmacological management of psychiatric comorbidities in patients with epilepsy

Biomarkers of Epileptogenesis: Psychiatric Comorbidities (?)

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