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Electroencephalogram effects of armodafinil: comparison with behavioral alertness.

ABSTRACT: Development of central nervous system-acting drugs would be enhanced by suitable biomarkers that reflect the targeted pathophysiologic brain state. The electroencephalogram (EEG) has several characteristics of an ideal biomarker and can be promptly adapted to pre-clinical and clinical testing. The aim of this study was to evaluate EEG as a measure of the wakefulness-promoting effect of armodafinil in sleep deprived healthy subjects. Armodafinil pharmacodynamics were simultaneously assessed by EEG- and behavioral-based measures including a well-established measure of alertness. Using two quantitative EEG-based measures-power spectral and event-related brain activity analyses-we observed that armodafinil mitigated the slowing of brain activity and the decrease of the event-related brain activity caused by sleep deprivation. Armodafinil-induced changes in EEG are in agreement and explain up to 73.1% of the armodafinil-induced changes in alertness. Our findings suggest that EEG can serve as a marker of the wakefulness-promoting drug effect.

SUBMITTER: Conrado DJ

PROVIDER: S-EPMC5527681 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Electroencephalogram effects of armodafinil: comparison with behavioral alertness.

Conrado Daniela J DJ Bewernitz Michael M Ding Mingzhou M Cibula Jean J Seubert Christoph C Sy Sherwin K B SK Eisenschenk Stephan S Derendorf Hartmut H

Journal of clinical pharmacology 20130801 10

Development of central nervous system-acting drugs would be enhanced by suitable biomarkers that reflect the targeted pathophysiologic brain state. The electroencephalogram (EEG) has several characteristics of an ideal biomarker and can be promptly adapted to pre-clinical and clinical testing. The aim of this study was to evaluate EEG as a measure of the wakefulness-promoting effect of armodafinil in sleep deprived healthy subjects. Armodafinil pharmacodynamics were simultaneously assessed by EE ...[more]

PMID: 23913585

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Project description:PURPOSE:Cancer-related insomnia is associated with diminished quality of life (QOL), suggesting that improvement in insomnia may improve QOL in cancer survivors. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia, but less is known regarding its effect on QOL and whether improvement in insomnia corresponds to improved QOL. The present analysis examines the effects of CBT-I, with and without armodafinil, on QOL both directly and indirectly through improvements of insomnia. METHODS:This is an analysis of 95 cancer survivors for a specified secondary aim of a four-arm randomized controlled trial assessing the combined and individual effects of CBT-I and armodafinil to improve insomnia. QOL and insomnia severity were assessed before, during the intervention, at post-intervention, and 3 months later by Functional Assessment of Cancer Therapy-General and Insomnia Severity Index, respectively. RESULTS:Mean change in QOL from pre- to post-intervention for CBT-I + placebo, CBT-I + armodafinil, armodafinil, and placebo was 9.6 (SE = 1.8; p < 0.0001), 11.6 (SE = 1.8; p < 0.0001), -0.2 (SE = 3.2; p = 0.964), and 3.3 (SE = 2.0; p = 0.124), respectively. ANCOVA controlling for pre-intervention scores showed that participants receiving CBT-I had significantly improved QOL at post-intervention compared to those not receiving CBT-I (p < 0.0001, effect size = 0.57), with benefits being maintained at the 3-month follow-up. Path analysis revealed that this improvement in QOL was due to improvement in insomnia severity (p = 0.002), and Pearson correlations showed that changes in QOL from pre- to post-intervention were significantly associated with concurrent changes in insomnia severity (r = -0.56; p < 0.0001). Armodafinil had no effect on QOL for those who did or did not receive it (p = 0.976; effect size = -0.004). CONCLUSION:In cancer survivors with insomnia, CBT-I resulted in clinically significant improvement in QOL via improvement in insomnia. This improvement in QOL remained stable even 3 months after completing CBT-I. IMPLICATIONS FOR CANCER SURVIVORS:Considering the high prevalence of insomnia and its detrimental impact on QOL in cancer survivors and the effectiveness of CBT-I in alleviating insomnia, it is important that evidence-based non-pharmacological sleep interventions such as CBT-I be provided as an integral part of cancer care.

Project description:Fatigue is a prevalent, distressing side effect of cancer and cancer treatment which commonly coexists with insomnia. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia in cancer patients, but less is known about its ability to impact fatigue. This work is the analysis for a secondary aim of a four-arm randomized controlled trial (RCT) study assessing the combined and comparative effect of CBT-I and a wakefulness-promoting agent, armodafinil (A), to improve sleep and daytime functioning in cancer survivors. Herein, we examine the effect of CBT-I, with and without A, on fatigue in cancer survivors.This study was a four-arm factorial study with CBTI-I (yes/no) versus A (yes/no). It consisted of 96 cancer survivors (average age 56 years; 88 % female; 68 % breast cancer). Fatigue was assessed by the brief fatigue inventory (BFI) and the FACIT-Fatigue scale. The analysis assessed the additive effects of CBT-I and A and possible non-additive effects where the effect of CBT-I changes depending on the presence or absence of A.Analyses adjusting for baseline differences showed that CBT-I improved fatigue as measured by two separate scales (BFI: P?=?0.002, Std. error?=?0.32, effect size (ES)?=?0.46; FACIT-Fatigue: P?<?0.001, Std. error?=?1.74, ES?=?0.64). Armodafinil alone did not show a statistically significant effect on fatigue levels (all Ps?>?0.40) nor did the drug influence the efficacy of CBT-I. Structural equation analysis revealed that reductions in insomnia severity were directly responsible for improving cancer-related fatigue.CBT-I with and without armodafinil resulted in a clinically and statistically significant reduction of subjective daytime fatigue in cancer survivors with chronic insomnia. Armodafinil did not improve cancer-related fatigue (CRF) and did not change the efficacy of CBT-I. Patients reporting CRF should be screened and, if indicated, treated for insomnia as part of a comprehensive fatigue management program.

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Electroencephalogram effects of armodafinil: comparison with behavioral alertness.

Publications

Electroencephalogram effects of armodafinil: comparison with behavioral alertness.

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