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Joris C. Verster - One of the best experts on this subject based on the ideXlab platform.
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next day effects of ramelteon 8 mg zopiclone 7 5 mg and placebo on highway driving Performance memory functioning Psychomotor Performance and mood in healthy adult subjects
Sleep, 2011Co-Authors: Monique Anna Johanna Mets, Edmund R. Volkerts, Juna M De Vries, Lieke M De Senerpont Domis, Berend Olivier, Joris C. VersterAbstract:STUDY OBJECTIVES: To evaluate the next-morning residual effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on driving Performance, memory functioning, Psychomotor Performance, and mood in healthy adult subjects following bedtime dosing and a middle of the night awakening. DESIGN: Single-center, randomized, double-blind, double-dummy, placebo-controlled, crossover study. SETTING: Utrecht University, The Netherlands. PARTICIPANTS: 30 healthy volunteers (15 males and 15 females). INTERVENTIONS: a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo, administered at bedtime. MEASUREMENTS: A balance test was performed at night. Other tests were performed the following morning, 8.5 h after administration. Subjects performed a 100-km highway driving test in normal traffic. Primary outcome measure was the standard deviation of the lateral position (SDLP), i.e., the weaving of the car. After driving, cognitive, memory, and Psychomotor tests were performed and mood was assessed. RESULTS: SDLP was significantly increased after the intake of ramelteon (+2.2 cm) and zopiclone (+2.9 cm). Ramelteon and zopiclone produced significant impairment on reaction time (P Language: en
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effects of an opioid oxycodone paracetamol and an nsaid bromfenac on driving ability memory functioning Psychomotor Performance pupil size and mood
The Clinical Journal of Pain, 2006Co-Authors: Joris C. Verster, Dieuwke S Veldhuijzen, Edmund R. VolkertsAbstract:Objective: It has been suggested that driving a car is relatively safe when the driver is treated with nonsteroid anti-inflammatory drugs than when he or she is treated with opioid analgesics. However, the evidence for this statement is scarce. The objective of this study was to determine the effects of a nonsteroid antiinflammatory drug (bromfenac 25 mg and 50 mg) and an opioid (oxycodone/paracetamol 5/325 mg and 10/650 mg), and placebo on driving ability, memory functioning, Psychomotor Performance, pupil size, and mood. Methods: Out of 30 healthy volunteers, 18 completed this randomized, double-blind, placebo-controlled crossover study, before the study had to be stopped due to bromfenac being pulled out from the market. One hour after administration of the drugs, the participants performed a standardized driving test during normal traffic. Thereafter, driving quality, mental effort and mental activation during driving were assessed. A laboratory test battery was performed 2.5 hours after administration of the drug. Visual analog scales assessing mood and pupil measurements were performed on several occasions during each test day. Results: Both analgesics did not significantly affect Performance in any test. However, volunteers reported that significantly more effort was needed to perform the driving test when treated with oxycodone/paracetamol, and that they experienced increased sedation and reduced alertness. Also, the pupil size was significantly decreased. In contrast, subjective assessments after both doses of bromfenac matched that of placebo. Discussion: No significant impairment in behavior was found in the volunteers for both bromfenac and oxycodone/paracetamol. The lack of impairment from oxycodone/paracetamol may have been related to the participants reporting increased effort during driving while under the influence of this drug.
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acute and subchronic effects of levocetirizine and diphenhydramine on memory functioning Psychomotor Performance and mood
The Journal of Allergy and Clinical Immunology, 2003Co-Authors: Joris C. Verster, Edmund R. Volkerts, Erik J E Eijken, Armand W A A Van Oosterwijck, Mounir Aarab, Saskia I R Bijtjes, Marit A De Weert, Marinus N VerbatenAbstract:Abstract Background: Central nervous system adverse effects, such as sedation, often accompany the use of first-generation antihistamines. These effects might interfere with memory functioning and Psychomotor Performance. Levocetirizine was recently introduced as a new antihistamine said to be free from sedative effects. Objective: We sought to investigate the effects of levocetirizine (5 mg), diphenhydramine (50 mg), and placebo on memory and Psychomotor Performance after acute (day 1) and subchronic (day 4) daily administration in 48 healthy volunteers (24 men and 24 women). Methods: This study was a double-blind, placebo-controlled, randomized clinical trial. Treatments were administrated on days 1, 2, 3, and 4, 3 hours before the start of the laboratory test battery (performed on days 1 and 4), comprising a word-learning test, the Sternberg Memory Scanning Test, a tracking test (easy and hard version), and a divided attention test (tracking and memory scanning simultaneously). Statistical analyses were performed separately for days 1 and 4 by using analysis of variance. Results: On day 1, diphenhydramine significantly impaired tracking Performance (easy: F 1,90 = 25.9, P 1,90 = 20.5, P 1,90 = 23.8, P 1,90 = 22.0, P
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residual effects of middle of the night administration of zaleplon and zolpidem on driving ability memory functions and Psychomotor Performance
Journal of Clinical Psychopharmacology, 2002Co-Authors: Joris C. Verster, Edmund R. Volkerts, Isabelle Paty, Mona Darwish, Antonia H C M L Schreuder, Erik J E Eijken, Janet H G Van Heuckelum, Dieuwke S Veldhuijzen, Marinus N Verbaten, Philippe DanjouAbstract:Thirty healthy volunteers participated in this two-part study. Part 1 was a single-blind, two-period crossover design to determine the effects of a single dose of ethanol (0.03% < BAC < 0.05%) or ethanol-placebo on driving ability, memory, and Psychomotor Performance. Part 2 was a double-blind, five-period crossover design to measure the effects of a middle-of-the-night administration of zaleplon 10 or 20 mg, zolpidem 10 or 20 mg, or placebo on driving ability 4 hours after administration and memory and Psychomotor Performance 6 hours after administration. The on-the-road driving test consisted of operating an instrumented automobile over a 100-km highway circuit at a constant speed (95 km/h) while maintaining a steady lateral position between the right lane boundaries. The standard deviation of lateral position (SDLP) was the primary Performance parameter of the driving test. The Psychomotor and memory test battery consisted of the Word Learning Test, the Critical Tracking Test, the Divided Attention Test, and the Digit Symbol Substitution Test. Data for each part were analyzed separately using ANOVA for crossover designs. Zaleplon 10 and 20 mg did not significantly impair driving ability 4 hours after middle-of-the-night administration. Relative to placebo, after zolpidem 10 mg, SDLP was significantly elevated, but the magnitude of the difference was small and not likely to be of clinical importance. Memory and Psychomotor test Performance was unaffected after both doses of zaleplon and zolpidem 10 mg. In contrast, zolpidem 20 mg significantly increased SDLP and speed variability. Further, zolpidem 20 mg significantly impaired Performance on all Psychomotor and memory tests. Finally, driving Performance, Digit Symbol Substitution Test, Divided Attention Test, and immediate and delayed free recall of the Word Learning Test were significantly impaired after ethanol. The results show that zaleplon (10 and 20 mg) is a safe hypnotic devoid of next-morning residual impairment when used in the middle of the night.
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effects of alprazolam on driving ability memory functioning and Psychomotor Performance a randomized placebo controlled study
Neuropsychopharmacology, 2002Co-Authors: Joris C. Verster, Edmund R. Volkerts, Marinus N VerbatenAbstract:Alprazolam is prescribed for the treatment of anxiety and panic disorder. Most users are presumably involved in daily activities such as driving. However, the effects of alprazolam on driving ability have never been investigated. This study was conducted to determine the effects of alprazolam (1 mg) on driving ability, memory and Psychomotor Performance. Twenty healthy volunteers participated in a randomized, double-blind, placebo-controlled crossover study. One hour after oral administration, subjects performed a standardized driving test on a primary highway during normal traffic. They were instructed to drive with a constant speed (90 km/h) while maintaining a steady lateral position within the right traffic lane. Primary Performance measures were the Standard Deviation of Lateral Position (SDLP) and the Standard Deviation of Speed (SDS). After the driving test, subjective driving quality, mental effort, and mental activation during driving were assessed. A laboratory test battery was performed 2.5 h after treatment administration, comprising the Sternberg Memory Scanning Test, a Continuous Tracking Test, and a Divided Attention Test. Relative to placebo, alprazolam caused serious driving impairment, as expressed by a significantly increased SDLP (F(1,19) = 97.3, p <.0001) and SDS (F(1,19) = 30.4, p <.0001). This was confirmed by subjective assessments showing significantly impaired driving quality (F(1,19) = 16.4, p <.001), decreased alertness (F(1,19) = 43.4, p <.0001), decreased mental activation (F(1,19) = 5.7, p <.03) and increased mental effort during driving (F(1,19) = 26.4, p <.0001). Furthermore, alprazolam significantly impaired Performance on the laboratory tests. In conclusion, alprazolam users must be warned not to drive an automobile or operate potentially dangerous machinery.
I Hindmarch - One of the best experts on this subject based on the ideXlab platform.
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benzodiazepine induced reduction in activity mirrors decrements in cognitive and Psychomotor Performance
Human Psychopharmacology-clinical and Experimental, 2008Co-Authors: Jean Dawson, I Hindmarch, Julia Boyle, N Stanley, Sigurd Johnsen, Debra J SkeneAbstract:Objective To assess whether actigraphy is sensitive to benzodiazepine-induced changes in cognitive and Psychomotor Performance and sleep. Methods Healthy young volunteers (n ¼ 23; 11 males), were randomised to a double-blind, placebo-controlled, crossover trial. Actigraphy was used to record motor activity continuously. Following dosing at 18.00 h with 2.5 mg lorazepam (LZP), Psychomotor and cognitive assessments were made at hourly intervals post-dose for 4 h and after sleep at 14.5 h post-dose. Results Activity levels were significantly reduced after LZP for 5 h post-dose ( p ¼ 0.0104), during sleep (5–13 h) ( p < 0.02) and the following morning, 13–14.5 h post-dose ( p < 0.02). At the same time cognitive and Psychomotor Performance was also significantly impaired ( p < 0.05). LZP also significantly increased actigraphic sleep efficiency and sleep per cent ( p < 0.02). Conclusion This study showed that activity levels were significantly reduced following dosing with a benzodiazepine and these changes coincided with impairment of cognitive and Psychomotor Performance. Actigraphy, therefore, appears to be able to reflect the psychopharmacological effects of a benzodiazepine in changes in daytime function and nocturnal behaviour, which, without waking the subject, is beyond the power of conventional psychometrics. Copyright # 2008 John Wiley & Sons, Ltd.
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sleep and daytime Psychomotor Performance during acute and continuation treatment of major depressive disorder double blind randomised controlled trial of escitalopram vs paroxetine
2008Co-Authors: David S Baldwin, Ruihua Hou, Ornah T Dolberg, S Schellberg, I HindmarchAbstract:Introduction. Disturbed sleep is a common depressive symptom which often persists despite otherwise successful pharmacological or psychological treatment, and is associated with increased risks of recurrence. As both worsened insomnia and daytime drowsiness are reported as treatment-emergent adverse effects with antidepressants, we wished to evaluate the effects of acute and continuation treatment on sleep and daytime Psychomotor Performance. Method. International, randomized, flexible-dose, parallel-group, comparator-controlled study involving 36 centres in 6 countries. Patients met DSM-IV criteria for current major depressive episode, with a baseline score of 22-40 on the Montgomery-Asberg Depression Rating Scale (MADRS). After a single-blind one-week placebo run-in, patients were randomized to escitalopram (ESC) (10-20 mg/day) or paroxetine (PAR) (20-40 mg/day) for 8 weeks of acute treatment: those who were significantly improved could continue fixed-dose double-blind treatment for a further 19 weeks. Sleep and early morning behaviour were assessed by the Leeds Sleep Evaluation Questionnaire (LSEQ), Psychomotor Performance by Critical FIicker Fusion (CFF) and Choice Reaction Time, and cognitive function by the Cognitive Failures Questionnaire (CFQ). Assessments were undertaken at baseline and weeks 4, 8, 16 and 27. Results. 323 patients (ESC, 165; PAR, 158) started acute treatment and received at least one dose of study medication. There were no significant differences between treatment groups in reduction of depressive symptoms from baseline to week 8, but in severely depressed patients (baseline MADRS >30) escitalopram was superior (p<0.05; ANCOVA) to paroxetine at week 27. Sleep and daytime Performance improved as depressive symptoms reduced. Two patients withdrew from the study due to the adverse effect of insomnia, and 1 due to somnolence. There were no significant differences between treatment groups in change from baseline on the LSEQ subscales for ‘getting to sleep’, ‘awakening from sleep’, or ‘behaviour following sleep’ although at week 4 ESC was superior (p<0.01; ANCOVA) to PAR on ‘quality of sleep’. There were no significant differences between treatment groups in the change from baseline in CFF, recognition or motor reaction times, or CFQ total score, at any of the scheduled assessments. Conclusion. In this study, only a small number of patients withdrew from antidepressant treatment due to adverse effects on sleep or daytime alertness. Repeated assessments of sleep and daytime Performance indicated a steady improvement during acute and continuation treatment of major depressive disorder with both escitalopram and paroxetine. Source of funding. The overall randomised controlled trial was sponsored by Lundbeck Ltd.
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comparative study of acute effects of single doses of fexofenadine olopatadine d chlorpheniramine and placebo on Psychomotor function in healthy volunteers
Human Psychopharmacology-clinical and Experimental, 2003Co-Authors: Hiroyuki Kamei, Koji Senzaki, Isao Muraoka, Kazuhiro Ishikawa, Yoshinori Hasegawa, Yukihiro Noda, I Hindmarch, Toshitaka NabeshimaAbstract:Since most classical (first-generation) antihistamines have undesirable sedative effects on the central nervous system (CNS), newer (second-generation) antihistamines have been developed to relieve the sedative effects and to improve the patient's quality of life. However, the Psychomotor profiles of second-generation antihistamines are not fully elucidated. In this randomized, double-blind, crossover study, the acute effects of single doses of second-generation antihistamines, fexofenadine (120 mg) and olopatadine (10 mg), on cognitive and Psychomotor Performance were investigated in comparison with those of placebo and d-chlorpheniramine (4 mg), a first-generation antihistamine, using objective and subjective assessments, in 11 healthy Japanese volunteers. In a battery of Psychomotor tests, d-chlorpheniramine impaired tracking ability in the compensatory tracking task and caused a reduction in behavioural activity as continuously measured by wrist actigraphy. Olopatadine, like d-chlorpheniramine, reduced the behavioural activity, while fexofenadine had no effect in any of the tests. No significant changes in the subjects' self-ratings of drowsiness were found with the three antihistamines. These results suggest that d-chlorpheniramine and olopatadine, but not fexofenadine, produce sedative effects on Psychomotor Performance, and that the CNS profile of fexofenadine is different from that of olopatadine.
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the effects of single and repeated administration of ebastine on cognition and Psychomotor Performance in comparison to triprolidine and placebo in healthy volunteers
Current Medical Research and Opinion, 2001Co-Authors: I Hindmarch, Z ShamsiAbstract:SummaryObjective:The cognitive and Psychomotor effects of 10 mg, 20 mg and 30 mg ebastine, a second generation H1-receptor antagonist, were compared with sustained release triprolidine 10mg (as averum) and placebo in 10 healthy volunteers in a double-blind, randomised crossover study.Methods: Following each dose, subjects were required to perform a series of tests of cognitive function and Psychomotor Performance at 1 h, 2 h, 4 h and 8 h post-dose on days 1 and 5. The test battery consisted of critical flicker fusion, choice reaction time, simulated car tracking task, Sternberg memory scanning task, assessment of subjective sedation (LARS) and subjective evaluation of sleep (LSEQ).Results: Ebastine at all doses investigated was not statistically significant from placebo in any of the objective tests used. However, as expected for a positive internal control, a number of objective measures were significantly disrupted by triprolidine (p < 0.05). Triprolidine produced an overall increase of the peripheral r...
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abrupt and brief discontinuation of antidepressant treatment effects on cognitive function and Psychomotor Performance
International Clinical Psychopharmacology, 2000Co-Authors: I Hindmarch, S Kimber, S M CockleAbstract:The abrupt discontinuation of antidepressants can result in a syndrome of adverse events, including somatic, mood and Psychomotor reactions. This study examined the effects of discontinuing and resuming antidepressant treatment with four selective serotonin reuptake inhibitors (SSRIs) on cognitive and Psychomotor function. Eighty-seven patients receiving maintenance therapy with fluoxetine, sertraline, paroxetine or citalopram had their treatment interrupted for 4-7 days using double-blind placebo. Assessments of aspects of cognitive and Psychomotor Performance, mood and symptoms were carried out at each visit. Following interruption of treatment, significant differences between the groups emerged. Paroxetine treated patients experienced significantly more cognitive failures (P = 0.007), poorer quality of sleep (P = 0.016), and an increase in depressive symptoms, as rated both subjectively, using the Zung scale (P = 0.006) and by the clinician, using the Montgomery-Asberg Depression Rating Scale (P = 0.0003) and Clinical Global Impression (P = 0.0003), compared to some or all of the other drugs. All changes were reversed on reinstatement of treatment. Abrupt discontinuation of treatment with paroxetine leads to deterioration in various aspects of health and functioning, which may be related to the antidepressant discontinuation syndrome. These effects are not evident in patients receiving fluoxetine, sertraline and citalopram, suggesting they are not an SSRI class phenomenon.
Johannes G. Ramaekers - One of the best experts on this subject based on the ideXlab platform.
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extended plasma cannabinoid excretion in chronic frequent cannabis smokers during sustained abstinence and correlation with Psychomotor Performance
Drug Testing and Analysis, 2016Co-Authors: Erin L Karschner, Johannes G. Ramaekers, Madeleine J Swortwood, Jussi Hirvonen, Robert S Goodwin, Wendy M Bosker, Marilyn A HuestisAbstract:Cannabis smoking increases motor vehicle accident risk. Empirically defined cannabinoid detection windows are important to drugged driving legislation. Our aims were to establish plasma cannabinoid detection windows in frequent cannabis smokers and to determine if residual cannabinoid concentrations were correlated with Psychomotor Performance. Twenty-eight male chronic frequent cannabis smokers resided on a secure research unit for up to 33 days with daily blood collection. Plasma specimens were analyzed for Δ(9) -tetrahydrocannabinol (THC), 11-hydroxy-THC (11-OH-THC), and 11-nor-9-carboxy-THC (THCCOOH) by gas chromatography-mass spectrometry. Critical tracking and divided attention tasks were administered at baseline (after overnight stay to ensure lack of acute intoxication) and after 1, 2, and 3 weeks of cannabis abstinence. Twenty-seven of the twenty-eight participants were THC-positive at admission (median 4.2 µg/L). THC concentrations significantly decreased 24 h after admission, but were still ≥2 µg/L in 16 of the 28 participants 48 h after admission. THC was detected in 3 of 5 specimens on day 30. The last positive 11-OH-THC specimen was 15 days after admission. THCCOOH was measureable in 4 of 5 participants after 30 days of abstinence. Years of prior cannabis use significantly correlated with THC concentrations on admission, and days 7 and 14. Tracking error, evaluated by the Divided Attention Task, was the only evaluated Psychomotor assessment significantly correlated with cannabinoid concentrations at baseline and day 8 (11-OH-THC only). Median THC was 0.3 µg/L in 5 chronic frequent cannabis smokers' plasma samples after 30 days of sustained abstinence. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.
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a randomized trial on the acute and steady state effects of a new antidepressant vortioxetine lu aa21004 on actual driving and cognition
Clinical Pharmacology & Therapeutics, 2013Co-Authors: Eef L. Theunissen, A. Van Oers, D Street, Am Hojer, A Vermeeren, Johannes G. RamaekersAbstract:The aim of this study was to assess the effects of a novel antidepressant, vortioxetine 10 mg, on driving, cognitive, and Psychomotor Performance in 24 healthy subjects in a double-blind, placebo-controlled, three-way crossover design. Mirtazapine 30 mg was included as an active comparator. Drugs were administered in the evening of 15 consecutive days. Performance was measured in the morning of days 2 and 16, using standardized tests measuring on-the-road driving, memory, tracking, divided attention, and vigilance. The statistical analysis on the primary measure of driving, i.e., SD of lateral position showed noninferiority of vortioxetine on days 2 and 16, and inferiority for mirtazapine on day 2. Vortioxetine did not cause cognitive or Psychomotor impairment. Mirtazapine, however, impaired cognitive and Psychomotor Performance on day 2. Most of these effects disappeared after multiple doses of mirtazapine. To conclude, vortioxetine did not impair driving, cognitive, or Psychomotor Performance after single or multiple doses.
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actual driving Performance and Psychomotor function in healthy subjects after acute and subchronic treatment with escitalopram mirtazapine and placebo a crossover trial
The Journal of Clinical Psychiatry, 2005Co-Authors: Marleen Wingen, John Bothmer, Stefan Langer, Johannes G. RamaekersAbstract:OBJECTIVE: The effects of escitalopram 10 to 20 mg/day and mirtazapine 30 to 45 mg/day on actual driving and Psychomotor Performance of 18 healthy subjects were determined in a randomized, double-blind, placebo-controlled, multiple-dose, 3-way crossover trial. METHOD: Each treatment period lasted for 15 days and was separated from the next period by a washout period of at least 13 days. Subjects received an evening dose of escitalopram 10 mg, mirtazapine 30 mg, or placebo from days 1 to 7 and an evening dose of escitalopram 20 mg, mirtazapine 45 mg, or placebo from days 8 to 15. On days 2, 9, and 16, reflecting acute period, dose increase, and steady state, respectively, the Road Tracking Test was performed. The main parameter was standard deviation of lateral position. Psychomotor Performance was also assessed on days 2, 9, and 16 by laboratory computer tasks. Subjective sleep quality was measured with the Groninger Sleep Quality Scale, and mood was measured by visual analogue scales. RESULTS: Treatment differences were apparent during the acute treatment period, in which subjects treated with mirtazapine 30 mg performed less well on the driving test as compared to placebo. The Divided Attention Task results also revealed a significant increase in tracking error after a single dose of mirtazapine 30 mg as compared to placebo. Mirtazapine decreased feelings of alertness and contentedness. Mirtazapine did not affect Performance on days 9 and 16 of treatment. Escitalopram did not affect driving, Psychomotor Performance, or subjective mood throughout treatment. CONCLUSION: Driving Performance, as well as Psychomotor functioning, was not affected by escitalopram treatment in healthy subjects. Driving Performance was significantly impaired after ingestion of mirtazapine 30 mg during the acute treatment period.
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effects of desloratadine diphenhydramine and placebo on driving Performance and Psychomotor Performance measurements
European Journal of Clinical Pharmacology, 2004Co-Authors: E F P M Vuurman, G H Rikken, N D Muntjewerff, F De Halleux, Johannes G. RamaekersAbstract:First-generation antihistamines taken for relief of allergic rhinitis are sedating and pose potential risks for those driving a car or operating machinery. Desloratadine is a potent, selective, histamine H1-receptor antagonist that does not easily cross the blood–brain barrier. It is nonsedating at therapeutic doses and should not affect driving or Psychomotor Performance. This study compared the acute effects of desloratadine with diphenhydramine (active control) and placebo on the Performance of healthy subjects evaluated with standard over-the-road driving tests (primary objective). The subjects’ Performances were also evaluated (secondary objective) with the use of conventional Performance tests. Eighteen men and women received a single dose of desloratadine 5 mg, diphenhydramine 50 mg, or placebo during each period of this randomized, double-blind, three-way, crossover study. Two hours post-dosing, subjects operated a specially instrumented vehicle in a 90-min test designed to measure their ability (1) to maintain constant speed and lateral position while following another vehicle at a constant distance and (2) to respond to brake signals. Additionally, a full battery of Performance tests was administered. No significant differences were noted between desloratadine and placebo in standard deviation of lateral position (SDLP), whereas diphenhydramine treatment significantly increased SDLP (P<0.001 for both comparisons). Brake reaction time was significantly faster following treatment with desloratadine than diphenhydramine (473.72 ms vs 541.22 ms; P<0.001) or placebo (512.06 ms; P=0.033). No differences were seen among treatments in deviation of speed or distance to the lead car. The majority of Performance tests showed no significant differences among groups. Desloratadine at a therapeutic dose does not impair driving Performance.
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A dose-ranging study of the effects of mequitazine on actual driving, memory and Psychomotor Performance as compared to dexchlorpheniramine, cetirizine and placebo
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2004Co-Authors: Eef L. Theunissen, Annemiek Vermeeren, A. Van Oers, I. Van Maris, Johannes G. RamaekersAbstract:BACKGROUND: Mequitazine is a so-called 'non-sedative' second-generation antihistamine even though it has never been firmly established that this drug's sedative potential actually differs from that of the 'sedative' first-generation antihistamines. OBJECTIVE: The present study compares the sedative effects of three doses of mequitazine on actual driving, Psychomotor Performance and memory with those of a first- and a second-generation antihistamine. METHODS: Eighteen healthy volunteers received on separate days a single dose of 5, 10 and 15 mg mequitazine, 10 mg cetirizine, 6 mg dexchlorpheniramine and placebo. Drug effects were assessed using two actual driving tests (highway-driving test and car-following test), cognitive and psychometric tests (tracking, divided attention, memory, reasoning and critical flicker fusion), pupil size and questionnaires. RESULTS: Highway-driving data revealed an overall effect of Treatment on the standard deviation of lateral position (SDLP). Dexchlorpheniramine impaired driving Performance as indicated by a significant rise in SDLP. Mequitazine significantly increased SDLP in a dose-related manner, but the separate dose effects failed to reach statistical significance. Divided attention Performance was also affected by Treatment. Reaction time (RT) during mequitazine treatments increased in a dose-related manner and significantly differed from placebo at the highest dose. Subjects reported to be less alert after treatment with dexchlorpheniramine. Cetirizine did not affect Performance in any of the tasks. CONCLUSION: It was concluded that mequitazine is mildly sedating. The effects of mequitazine are comparable to those of other second-generation antihistamines, in that it causes mild driving impairment, particularly at higher doses. Language: en
Edmund R. Volkerts - One of the best experts on this subject based on the ideXlab platform.
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next day effects of ramelteon 8 mg zopiclone 7 5 mg and placebo on highway driving Performance memory functioning Psychomotor Performance and mood in healthy adult subjects
Sleep, 2011Co-Authors: Monique Anna Johanna Mets, Edmund R. Volkerts, Juna M De Vries, Lieke M De Senerpont Domis, Berend Olivier, Joris C. VersterAbstract:STUDY OBJECTIVES: To evaluate the next-morning residual effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on driving Performance, memory functioning, Psychomotor Performance, and mood in healthy adult subjects following bedtime dosing and a middle of the night awakening. DESIGN: Single-center, randomized, double-blind, double-dummy, placebo-controlled, crossover study. SETTING: Utrecht University, The Netherlands. PARTICIPANTS: 30 healthy volunteers (15 males and 15 females). INTERVENTIONS: a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo, administered at bedtime. MEASUREMENTS: A balance test was performed at night. Other tests were performed the following morning, 8.5 h after administration. Subjects performed a 100-km highway driving test in normal traffic. Primary outcome measure was the standard deviation of the lateral position (SDLP), i.e., the weaving of the car. After driving, cognitive, memory, and Psychomotor tests were performed and mood was assessed. RESULTS: SDLP was significantly increased after the intake of ramelteon (+2.2 cm) and zopiclone (+2.9 cm). Ramelteon and zopiclone produced significant impairment on reaction time (P Language: en
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effects of an opioid oxycodone paracetamol and an nsaid bromfenac on driving ability memory functioning Psychomotor Performance pupil size and mood
The Clinical Journal of Pain, 2006Co-Authors: Joris C. Verster, Dieuwke S Veldhuijzen, Edmund R. VolkertsAbstract:Objective: It has been suggested that driving a car is relatively safe when the driver is treated with nonsteroid anti-inflammatory drugs than when he or she is treated with opioid analgesics. However, the evidence for this statement is scarce. The objective of this study was to determine the effects of a nonsteroid antiinflammatory drug (bromfenac 25 mg and 50 mg) and an opioid (oxycodone/paracetamol 5/325 mg and 10/650 mg), and placebo on driving ability, memory functioning, Psychomotor Performance, pupil size, and mood. Methods: Out of 30 healthy volunteers, 18 completed this randomized, double-blind, placebo-controlled crossover study, before the study had to be stopped due to bromfenac being pulled out from the market. One hour after administration of the drugs, the participants performed a standardized driving test during normal traffic. Thereafter, driving quality, mental effort and mental activation during driving were assessed. A laboratory test battery was performed 2.5 hours after administration of the drug. Visual analog scales assessing mood and pupil measurements were performed on several occasions during each test day. Results: Both analgesics did not significantly affect Performance in any test. However, volunteers reported that significantly more effort was needed to perform the driving test when treated with oxycodone/paracetamol, and that they experienced increased sedation and reduced alertness. Also, the pupil size was significantly decreased. In contrast, subjective assessments after both doses of bromfenac matched that of placebo. Discussion: No significant impairment in behavior was found in the volunteers for both bromfenac and oxycodone/paracetamol. The lack of impairment from oxycodone/paracetamol may have been related to the participants reporting increased effort during driving while under the influence of this drug.
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acute and subchronic effects of levocetirizine and diphenhydramine on memory functioning Psychomotor Performance and mood
The Journal of Allergy and Clinical Immunology, 2003Co-Authors: Joris C. Verster, Edmund R. Volkerts, Erik J E Eijken, Armand W A A Van Oosterwijck, Mounir Aarab, Saskia I R Bijtjes, Marit A De Weert, Marinus N VerbatenAbstract:Abstract Background: Central nervous system adverse effects, such as sedation, often accompany the use of first-generation antihistamines. These effects might interfere with memory functioning and Psychomotor Performance. Levocetirizine was recently introduced as a new antihistamine said to be free from sedative effects. Objective: We sought to investigate the effects of levocetirizine (5 mg), diphenhydramine (50 mg), and placebo on memory and Psychomotor Performance after acute (day 1) and subchronic (day 4) daily administration in 48 healthy volunteers (24 men and 24 women). Methods: This study was a double-blind, placebo-controlled, randomized clinical trial. Treatments were administrated on days 1, 2, 3, and 4, 3 hours before the start of the laboratory test battery (performed on days 1 and 4), comprising a word-learning test, the Sternberg Memory Scanning Test, a tracking test (easy and hard version), and a divided attention test (tracking and memory scanning simultaneously). Statistical analyses were performed separately for days 1 and 4 by using analysis of variance. Results: On day 1, diphenhydramine significantly impaired tracking Performance (easy: F 1,90 = 25.9, P 1,90 = 20.5, P 1,90 = 23.8, P 1,90 = 22.0, P
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residual effects of middle of the night administration of zaleplon and zolpidem on driving ability memory functions and Psychomotor Performance
Journal of Clinical Psychopharmacology, 2002Co-Authors: Joris C. Verster, Edmund R. Volkerts, Isabelle Paty, Mona Darwish, Antonia H C M L Schreuder, Erik J E Eijken, Janet H G Van Heuckelum, Dieuwke S Veldhuijzen, Marinus N Verbaten, Philippe DanjouAbstract:Thirty healthy volunteers participated in this two-part study. Part 1 was a single-blind, two-period crossover design to determine the effects of a single dose of ethanol (0.03% < BAC < 0.05%) or ethanol-placebo on driving ability, memory, and Psychomotor Performance. Part 2 was a double-blind, five-period crossover design to measure the effects of a middle-of-the-night administration of zaleplon 10 or 20 mg, zolpidem 10 or 20 mg, or placebo on driving ability 4 hours after administration and memory and Psychomotor Performance 6 hours after administration. The on-the-road driving test consisted of operating an instrumented automobile over a 100-km highway circuit at a constant speed (95 km/h) while maintaining a steady lateral position between the right lane boundaries. The standard deviation of lateral position (SDLP) was the primary Performance parameter of the driving test. The Psychomotor and memory test battery consisted of the Word Learning Test, the Critical Tracking Test, the Divided Attention Test, and the Digit Symbol Substitution Test. Data for each part were analyzed separately using ANOVA for crossover designs. Zaleplon 10 and 20 mg did not significantly impair driving ability 4 hours after middle-of-the-night administration. Relative to placebo, after zolpidem 10 mg, SDLP was significantly elevated, but the magnitude of the difference was small and not likely to be of clinical importance. Memory and Psychomotor test Performance was unaffected after both doses of zaleplon and zolpidem 10 mg. In contrast, zolpidem 20 mg significantly increased SDLP and speed variability. Further, zolpidem 20 mg significantly impaired Performance on all Psychomotor and memory tests. Finally, driving Performance, Digit Symbol Substitution Test, Divided Attention Test, and immediate and delayed free recall of the Word Learning Test were significantly impaired after ethanol. The results show that zaleplon (10 and 20 mg) is a safe hypnotic devoid of next-morning residual impairment when used in the middle of the night.
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effects of alprazolam on driving ability memory functioning and Psychomotor Performance a randomized placebo controlled study
Neuropsychopharmacology, 2002Co-Authors: Joris C. Verster, Edmund R. Volkerts, Marinus N VerbatenAbstract:Alprazolam is prescribed for the treatment of anxiety and panic disorder. Most users are presumably involved in daily activities such as driving. However, the effects of alprazolam on driving ability have never been investigated. This study was conducted to determine the effects of alprazolam (1 mg) on driving ability, memory and Psychomotor Performance. Twenty healthy volunteers participated in a randomized, double-blind, placebo-controlled crossover study. One hour after oral administration, subjects performed a standardized driving test on a primary highway during normal traffic. They were instructed to drive with a constant speed (90 km/h) while maintaining a steady lateral position within the right traffic lane. Primary Performance measures were the Standard Deviation of Lateral Position (SDLP) and the Standard Deviation of Speed (SDS). After the driving test, subjective driving quality, mental effort, and mental activation during driving were assessed. A laboratory test battery was performed 2.5 h after treatment administration, comprising the Sternberg Memory Scanning Test, a Continuous Tracking Test, and a Divided Attention Test. Relative to placebo, alprazolam caused serious driving impairment, as expressed by a significantly increased SDLP (F(1,19) = 97.3, p <.0001) and SDS (F(1,19) = 30.4, p <.0001). This was confirmed by subjective assessments showing significantly impaired driving quality (F(1,19) = 16.4, p <.001), decreased alertness (F(1,19) = 43.4, p <.0001), decreased mental activation (F(1,19) = 5.7, p <.03) and increased mental effort during driving (F(1,19) = 26.4, p <.0001). Furthermore, alprazolam significantly impaired Performance on the laboratory tests. In conclusion, alprazolam users must be warned not to drive an automobile or operate potentially dangerous machinery.
Marinus N Verbaten - One of the best experts on this subject based on the ideXlab platform.
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acute and subchronic effects of levocetirizine and diphenhydramine on memory functioning Psychomotor Performance and mood
The Journal of Allergy and Clinical Immunology, 2003Co-Authors: Joris C. Verster, Edmund R. Volkerts, Erik J E Eijken, Armand W A A Van Oosterwijck, Mounir Aarab, Saskia I R Bijtjes, Marit A De Weert, Marinus N VerbatenAbstract:Abstract Background: Central nervous system adverse effects, such as sedation, often accompany the use of first-generation antihistamines. These effects might interfere with memory functioning and Psychomotor Performance. Levocetirizine was recently introduced as a new antihistamine said to be free from sedative effects. Objective: We sought to investigate the effects of levocetirizine (5 mg), diphenhydramine (50 mg), and placebo on memory and Psychomotor Performance after acute (day 1) and subchronic (day 4) daily administration in 48 healthy volunteers (24 men and 24 women). Methods: This study was a double-blind, placebo-controlled, randomized clinical trial. Treatments were administrated on days 1, 2, 3, and 4, 3 hours before the start of the laboratory test battery (performed on days 1 and 4), comprising a word-learning test, the Sternberg Memory Scanning Test, a tracking test (easy and hard version), and a divided attention test (tracking and memory scanning simultaneously). Statistical analyses were performed separately for days 1 and 4 by using analysis of variance. Results: On day 1, diphenhydramine significantly impaired tracking Performance (easy: F 1,90 = 25.9, P 1,90 = 20.5, P 1,90 = 23.8, P 1,90 = 22.0, P
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residual effects of middle of the night administration of zaleplon and zolpidem on driving ability memory functions and Psychomotor Performance
Journal of Clinical Psychopharmacology, 2002Co-Authors: Joris C. Verster, Edmund R. Volkerts, Isabelle Paty, Mona Darwish, Antonia H C M L Schreuder, Erik J E Eijken, Janet H G Van Heuckelum, Dieuwke S Veldhuijzen, Marinus N Verbaten, Philippe DanjouAbstract:Thirty healthy volunteers participated in this two-part study. Part 1 was a single-blind, two-period crossover design to determine the effects of a single dose of ethanol (0.03% < BAC < 0.05%) or ethanol-placebo on driving ability, memory, and Psychomotor Performance. Part 2 was a double-blind, five-period crossover design to measure the effects of a middle-of-the-night administration of zaleplon 10 or 20 mg, zolpidem 10 or 20 mg, or placebo on driving ability 4 hours after administration and memory and Psychomotor Performance 6 hours after administration. The on-the-road driving test consisted of operating an instrumented automobile over a 100-km highway circuit at a constant speed (95 km/h) while maintaining a steady lateral position between the right lane boundaries. The standard deviation of lateral position (SDLP) was the primary Performance parameter of the driving test. The Psychomotor and memory test battery consisted of the Word Learning Test, the Critical Tracking Test, the Divided Attention Test, and the Digit Symbol Substitution Test. Data for each part were analyzed separately using ANOVA for crossover designs. Zaleplon 10 and 20 mg did not significantly impair driving ability 4 hours after middle-of-the-night administration. Relative to placebo, after zolpidem 10 mg, SDLP was significantly elevated, but the magnitude of the difference was small and not likely to be of clinical importance. Memory and Psychomotor test Performance was unaffected after both doses of zaleplon and zolpidem 10 mg. In contrast, zolpidem 20 mg significantly increased SDLP and speed variability. Further, zolpidem 20 mg significantly impaired Performance on all Psychomotor and memory tests. Finally, driving Performance, Digit Symbol Substitution Test, Divided Attention Test, and immediate and delayed free recall of the Word Learning Test were significantly impaired after ethanol. The results show that zaleplon (10 and 20 mg) is a safe hypnotic devoid of next-morning residual impairment when used in the middle of the night.
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effects of alprazolam on driving ability memory functioning and Psychomotor Performance a randomized placebo controlled study
Neuropsychopharmacology, 2002Co-Authors: Joris C. Verster, Edmund R. Volkerts, Marinus N VerbatenAbstract:Alprazolam is prescribed for the treatment of anxiety and panic disorder. Most users are presumably involved in daily activities such as driving. However, the effects of alprazolam on driving ability have never been investigated. This study was conducted to determine the effects of alprazolam (1 mg) on driving ability, memory and Psychomotor Performance. Twenty healthy volunteers participated in a randomized, double-blind, placebo-controlled crossover study. One hour after oral administration, subjects performed a standardized driving test on a primary highway during normal traffic. They were instructed to drive with a constant speed (90 km/h) while maintaining a steady lateral position within the right traffic lane. Primary Performance measures were the Standard Deviation of Lateral Position (SDLP) and the Standard Deviation of Speed (SDS). After the driving test, subjective driving quality, mental effort, and mental activation during driving were assessed. A laboratory test battery was performed 2.5 h after treatment administration, comprising the Sternberg Memory Scanning Test, a Continuous Tracking Test, and a Divided Attention Test. Relative to placebo, alprazolam caused serious driving impairment, as expressed by a significantly increased SDLP (F(1,19) = 97.3, p <.0001) and SDS (F(1,19) = 30.4, p <.0001). This was confirmed by subjective assessments showing significantly impaired driving quality (F(1,19) = 16.4, p <.001), decreased alertness (F(1,19) = 43.4, p <.0001), decreased mental activation (F(1,19) = 5.7, p <.03) and increased mental effort during driving (F(1,19) = 26.4, p <.0001). Furthermore, alprazolam significantly impaired Performance on the laboratory tests. In conclusion, alprazolam users must be warned not to drive an automobile or operate potentially dangerous machinery.
