Psychomotor Performance In Healthy Volunteers Research Articles

The post-lunch effect of regular and decaffeinated coffee on psychomotor performance: a randomized double-blind cross-over study

Background: This study aimed to compare the effect of regular coffee and decaffeinated coffee on psychomotor performance in healthy volunteers during post-lunch period.Methods: In this randomized double-blind cross-over study, adult healthy volunteers were given hot coffee (3 g each of regular or decaffeinated coffee) during post-lunch period. Psychomotor functions (critical flicker-fusion frequency (CFF), choice reaction time (CRT) and error count in hand-steadiness test (HST)), blood pressure and heart rate were measured pre-lunch, pre-coffee (1-hour post-lunch) and 1-hour post-coffee consumption. Subjective ratings of sleepiness and mood were also assessed during post-lunch sessions.Results: The mean age of the participants (n=16) was 27.4±2.7 years with a male: female ratio of 7:9. There was no significant deterioration in psychomotor performance post-lunch when compared to pre-lunch on both the days. The mean CFF, CRT, errors committed in HST and cardiovascular parameters did not differ significantly between regular coffee and decaffeinated groups during post-lunch sessions. There was no significant difference in values of cardiovascular parameters as well as subjective ratings of sleep and mood between two groups.Conclusions: In healthy adult individuals’ consumption of both regular coffee and decaffeinated coffee during the post-lunch period did not affect psychomotor performance.

Comparative evaluation of aliskiren, ramipril, and losartan on psychomotor performance in healthy volunteers: A preliminary report.

Aim:To compare the effects of aliskiren, ramipril, and losartan on the psychomotor performance in healthy volunteers.Materials and Methods:In this preliminary, single-dose, open-label, cross-over study conducted in 12 healthy volunteers, psychomotor assessment was carried out by four tests: Simple reaction time (SRT), multiple choice reaction time test (MCRT), critical flicker fusion frequency threshold test (CFFT), and tracking performance test (TPT). Each volunteer received a single dose of each of the three test drugs with a washout period of 10 days between different test sessions and then evaluated for post-drug scores at 2-h intervals up to 12 h and then at 24 h. The changes from the baseline scores by the test drug were statistically analyzed.Results:All the three antihypertensive drugs caused significant improvement in a similar fashion on SRT, MCRT calculated as error index, CFFT, and TPT. Aliskiren caused numerically more improvement than the other two test drugs, suggesting better cognitive profile. However, inter-drug comparisons were nonsignificant.Conclusion:The results of the study highlight improvement of the cognitive functions equally by ramipril, losartan, and aliskiren. The results of the study could be of immense clinical utility in ambulatory hypertensive patients especially engaged in sensory-motor coordination tasks like driving and operating on mechanical tools.

Comparative study of effects of gabapentin, vigabatrin and sodium valproate on psychomotor performance in healthy volunteers

Context: The cognitive and psychomotor functions may become impaired in epileptic patients due to underlying etiology, effect of seizures and side-effects of antiepileptic drugs. It is desirable for the drug to have a minimal effect on cognitive abilities. Few studies have evaluated the psychomotor effects of newer antiepileptic agents and hence do not have the proper evidence base for their psychomotor adverse effects. Aims: The aim of this study is to evaluate the effects of gabapentin (GBP), vigabatrin (VGB), valproate (VAL) on psychomotor functions. Settings and Design: Randomized, prospective, double-blind, placebo (PLB) controlled crossover study. Subjects and Methods: A total of 24 healthy volunteers were included to administer single oral doses of GBP 300 mg, VGB 500 mg, sodium valproate 200 mg and PLB following a Latin square design. The objective parameters - six-digit cancellation test, digit symbol substitution test, critical flicker fusion test, arithmetic ability test, digit span test, hand steadiness test and subjective parameters like visual analog scale (VAS) were tested at 0, 1, 2 and 3 h. Statistical Analysis Used: Repeated measures ANOVA was used to compare the difference in mean score. Fisher's exact test was used for statistical analysis of adverse effects. Results: Sodium valproate impaired all subjective and objective psychomotor functions while GBP, VGB did not show any impairment when compared with PLB. GBP when compared with VGB, no difference was observed in any test, but when both the drugs were compared with sodium valproate, statistically significant difference at the end of third hourwas observed. Conclusions: VGB and GBP have few adverse cognitive and psychomotor effects as compared with sodium valproate, therefore are safe as add on therapy or monotherapy.

Bilastine in allergic rhinoconjunctivitis and urticaria

To cite this article: Bachert C, Kuna P, Zuberbier T. Bilastine in allergic rhinoconjunctivitis and urticaria. Allergy 2010; 65 (Suppl. 93): 1–13.AbstractAllergic rhinoconjunctivitis and urticaria are increasing in prevalence in many developed countries. The role of histamine in such conditions is well documented and clinical guidelines recommend non‐sedating H1‐receptor antagonists as first‐line treatment choices. Bilastine is a novel non‐sedating histamine H1‐receptor antagonist developed for the treatment of allergic rhinoconjunctivitis and urticaria. The aim of this review is to critique the scientific evidence relating to the pharmacological properties of bilastine and the clinical evidence regarding its potential as an antihistamine. In vitro binding studies and investigations in animal tissue have demonstrated the high specificity of bilastine for H1‐receptors, and preclinical animal studies have also yielded promising results in terms of a reduction of histamine‐mediated inflammatory effects, including capillary permeability and bronchospasm. In pharmacodynamic studies bilastine was found to down‐regulate histamine‐induced flare and wheal responses in healthy volunteers. Preclinical and clinical pharmacokinetic studies showed that bilastine has dose‐dependent kinetics following oral administration. Excretion is almost exclusively via urine and faeces as unchanged drug. Early clinical trials have shown that bilastine has similar efficacy to other second‐generation H1‐receptor antagonists such as cetirizine, desloratadine, fexofenadine and levocetirizine, in terms of reducing allergic symptoms. Clinical findings also indicate that bilastine has a rapid onset of action and a 20 mg single dose is effective throughout a 24‐h period. Furthermore, bilastine has been associated with improved quality of life in allergic rhinoconjunctivitis and urticaria patients. Adverse effects have generally been minimal in these studies and doses up to twice those proposed did not exhibit differences in adverse events compared to placebo. Moreover, in vivo investigations have found no evidence of accumulation of bilastine in the central nervous system, and various studies have confirmed minimal effects on psychomotor performance in healthy volunteers administered up to four times the usual dose. Clinical studies have also found no effect of bilastine on the QTc interval and other ECG parameters, even at supratherapeutic dosages, confirming the good cardiac safety profile of this newer antihistamine. Given its pharmacodynamic profile, which appears to be similar to other second‐generation H1‐receptor antagonists, and its favourable safety and tolerability, bilastine has the attributes of a potentially clinically useful non‐sedating antihistamine. Larger clinical studies are now necessary to fully elucidate the clinical potential of this novel antihistamine.

Effects of loratadine/montelukast on vigilance and alertness task Performance in a simulated cabin environment

Sedating effects of some medications used to treat allergic rhinitis (AR) symptoms can impair an individual's ability to function optimally. The objective of this study was to characterize the effects of a single dose of loratadine/montelukast (L/M) versus placebo and diphenhydramine on daytime somnolence and psychomotor performance in healthy volunteers. In this single-center, randomized, double-blind, placebo- and active-controlled,three-way crossover study, healthy volunteers received single doses of placebo, L/M 10 mg/10 mg, and diphenhydramine 50 mg. Subjects (n=23) were evaluated under simulated cabin pressure using the following tools: Vigilance and Tracking Task (VigTrack), measuring vigilance and tracking performance; the Multi-Attribute Task Battery (MAT), measuring ability to perform multiple tasks simultaneously; and the Stanford Sleepiness Scale (SSS), measuring sedative effects of medication, at baseline and each hour from 1 to 6 hours postdose. Safety was monitored via adverse events and vital signs. Performances on VigTrack and MAT from 1 to 6 hours after dosing were not significantly different between L/M and placebo groups; in contrast, diphenhydramine resulted in significant impairment of tracking for up to 5 hours (P< or =0.01) and vigilance performance for up to 3 hours (P< or =0.05) on VigTrack versus placebo. Scores of subjective sleepiness as measured by SSS were similar for patients treated with L/M versus placebo, whereas significant increases in sleepiness occurred between 1-5 hours posttreatment in diphenhydramine-treated patients versus placebo-treated patients (P< or =0.05). L/M is similar to placebo in effects on daytime somnolence and psychomotor performance. L/M treatment resulted in significantly less sleepiness and impairment of vigilance and tracking than diphenhydramine.

A Double-blind Placebo-controlled Investigation of the Psychomotor Profile of Clopidogrel in Healthy Volunteers

Clopidogrel is a thienopyridine antiplatelet agent that inhibits adenosine diphosphate-dependent platelet activation and aggregation and is currently one of the most widely prescribed antiplatelet drugs for the treatment of symptomatic coronary artery disease. Several large clinical trials have demonstrated that it has a potent protective effect against adverse vascular events, including coronary, cerebral, and peripheral arterial disease. These clinical trials have reported among other clopidogrel's adverse effects, the adverse effects related to the central nervous system including headache and dizziness occurring in 7.6% and 6.2% of patients, respectively. Aim of this study is to detect possible effect of clopidogrel on human psychomotor performance in healthy volunteers. Using a double-blind, placebo-controlled, balanced, between-subject design at laboratories of the pharmacology department in Al-Mustansiryiah University Medical College, Baghdad, Iraq, during the academic year 2007-2008. Fifty-four young healthy volunteers were enrolled, they received either single oral doses of clopidogrel 37.5 mg (Plavix; Sanofi-Synthelabo) or placebo. Each treatment was given to 27 subjects. Measurements of psychomotor performance including the choice reaction time and its 2 components, recognition reaction time and movement reaction time, and the critical flicker fusion threshold using the computerized Leed psychomotor tester were performed just before medication and 2 hours afterward. No statistically significant difference in the parameters measured was detected among the two treatment groups. In this study, we found that single oral doses of clopidogrel in our group of normal healthy volunteers did not affect their psychomotor performance.

Effects of ceronapril alone or in combination with alcohol on psychomotor performance in healthy volunteers: a placebo-controlled, crossover study

Background: Behavioral evidence from animal studies has suggested that ceronapril and other angiotensin-converting enzyme (ACE) inhibitors have some anxiolytic activity. Objectives: The objectives of this trial were to assess the effects of ceronapril, a centrally acting ACE inhibitor, on psychomotor performance in healthy volunteers; to compare its effects with those of lorazepam, a known anxiolytic agent; and to determine whether ceronapril interacts pharmacodynamically with alcohol. Methods: Twelve healthy male volunteers received ceronapril (80 mg), lorazepam (2 mg), or corresponding placebo twice daily for 7 days in a randomized, double-blind, placebo-controlled, crossover study. Psychomotor tests were performed on days 1 and 7 of each treatment period. On the testing days, the subjects ingested alcohol (1 g/kg) over a 30-minute period, 2 hours after drug administration. Psychomotor tests (simulated driving task, critical flicker fusion, body sway, lateral-gaze nystagmus, Maddox wing test, Mini—Mental State Examination, and subjective assessments) were performed before the administration of the morning dose and 1 hour, 3 hours (40 minutes post-alcohol), and 4 hours (100 minutes post-alcohol) after drug administration. Results: On day 1, ceronapril did not impair psychomotor performance, and its effects were comparable to those of placebo before and after alcohol ingestion. Lorazepam impaired most of the psychomotor functions, and its effects were enhanced by alcohol. On day 7, ceronapril decreased systolic blood pressure, but otherwise its effects were similar to those of placebo. Due to development of tolerance, lorazepam had few psychomotor effects after the subchronic administration. Conclusions: Ceronapril was found to have no anxiolytic effects or effects on psychomotor performance in this sample of healthy volunteers.

An investigation into the effects of cetirizine on cognitive function and psychomotor performance in healthy volunteers

The cognitive and psychomotor effects of 2.5, 5 and 10 mg cetirizine, a second-generation H1 receptor antagonist, were compared with loratadine 10, 20 and 40 mg, promethazine 25 mg and placebo in 24 healthy volunteers in a double-blind, randomised cross-over study. Following each dose, subjects were required to perform a series of tests of cognitive function and psychomotor performance at 1.5, 3 and 6 h post-dose. The test battery consisted of critical flicker fusion (CFF), choice reaction time (CRT), compensatory tracking task (CTT) and assessment of subjective sedation (LARS). Cetirizine and loratadine at all doses tested were not significantly different from placebo in any of the tests used. However, as expected for a verum, all measures with the exception of CTT were significantly disrupted by promethazine (P < 0.05). Promethazine caused a reduction in CFF threshold at all test points; these differences were significant at 3 h and 6 h post-dose (P < 0.05). There was also a significant increase in total reaction time at 3 h post-promethazine administration. Subjective reports of sedation were significantly greater following the administration of promethazine at all time points (P < 0.05). These results allow the conclusion that cetirizine at its recommended therapeutic dose of 10 mg is demonstrably free from disruptive effects on aspects of psychomotor and cognitive function in a study where the psychometric assessments have been shown to be sensitive to impairment, as evidenced by the effects of the positive control, promethazine 25 mg.

Desloratadine.

Desloratadine is the orally active major metabolite of the nonsedating H1-antihistamine loratadine. The drug had no adverse cardiovascular effects in various animal models or when administered at 9 times the recommended adult dosage for 10 days in volunteers. Therapeutic dosages had no effects on wakefulness or psychomotor performance in healthy volunteers. No clinically significant interactions have been reported between desloratadine and drugs that inhibit the cytochrome P450 system, nor does the drug potentiate the adverse psychomotor effects of alcohol. Oral desloratadine 5 mg once daily for up to 4 weeks in patients with seasonal allergic rhinitis (SAR) significantly reduced nasal (including congestion) and non-nasal symptoms and improved health-related quality of life compared with placebo. Similar beneficial effects were observed in patients with SAR and coexisting asthma (in whom asthma symptoms and use of beta2-agonists were reduced). Desloratadine 5 mg once daily for 6 weeks significantly improved pruritus and reduced the number of hives compared with placebo in patients with chronic idiopathic urticaria (CIU). Sleep and daytime performance also improved. Desloratadine was well tolerated in clinical trials and had an adverse event profile similar to that of placebo in patients with SAR (with or without asthma) or CIU.

The effects of acute doses of standardised Ginkgo Biloba Extract on memory and psychomotor performance in healthy volunteers

The effects of acute doses of standardised Ginkgo Biloba Extract on memory and psychomotor performance in healthy volunteers

The Effects of Subanesthetic Concentrations of Sevoflurane and Nitrous Oxide, Alone and in Combination, on Analgesia, Mood, and Psychomotor Performance in Healthy Volunteers

We studied the effects of subanesthetic concentrations of sevoflurane and nitrous oxide, alone and in combination, on analgesia, mood, and psychomotor performance in human volunteers. We hypothesized that nitrous oxide and sevoflurane would produce both opposing and potentiating effects within the same study. Over the course of three sessions, 20 subjects inhaled 0%, 0.2%, or 0.4% end-tidal sevoflurane for a 68-min period that was divided into four 17-min blocks. During either the second or fourth block, 30% end-tidal nitrous oxide was added to the concentration of sevoflurane being inhaled. Pain response, psychomotor performance, and mood were evaluated during the second and fourth blocks. Pain ratings were higher when sevoflurane and nitrous oxide were administered together than when nitrous oxide was administered alone, which indicates that sevoflurane attenuated the analgesic effects of nitrous oxide. Sevoflurane increased self-reported ratings of sleepiness, and the addition of nitrous oxide decreased these ratings. Nitrous oxide potentiated psychomotor impairment that was induced by sevoflurane. The combination of sevoflurane and nitrous oxide produced both opposing and potentiating effects within the same study. The results suggest that nitrous oxide and sevoflurane may act through different neurochemical mechanisms on some end points, such as analgesia and sleepiness. Healthy volunteers inhaled subanesthetic concentrations of sevoflurane and nitrous oxide. Sevoflurane made nitrous oxide less effective as an analgesic, and nitrous oxide made sevoflurane less effective as a sedative. The two drugs may work at cross purposes on different end points of anesthesia.

The Effects of Subanesthetic Concentrations of Sevoflurane and Nitrous Oxide, Alone and in Combination, on Analgesia, Mood, and Psychomotor Performance in Healthy Volunteers

The Effects of Subanesthetic Concentrations of Sevoflurane and Nitrous Oxide, Alone and in Combination, on Analgesia, Mood, and Psychomotor Performance in Healthy Volunteers

Decrease in short-term memory function induced by CCK-4 in healthy volunteers

The purpose of this study was to assess the effects of continuous intravenous infusion of the central cholecystokinin (CCK) receptor agonist, CCK-4, on short-term memory and psychomotor performance in healthy volunteers in a double-blind, placebo-controlled, parallel group study. Compared to placebo, CCK-4 (0.5 mg/h) significantly impaired performance on free-recall and recognition of words in the middle of the CCK-4 infusion, but did not affect psychomotor acuity. The results of this study indicate that CCK-4 may exert a negative influence on memory consolidation and retrieval.

The Acute and Residual Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide Combinations on Cognitive and Psychomotor Performance in Healthy Volunteers

ZACNY, J. P.; YAJNIK, S.; LICHTOR, L.; KLAFTA, J. M.; YOUNG, C. J.; THAPAR, P.; RUPANI, G.; COALSON, D. W.; APFELBAUM, J. L. Author Information

The Acute and Residual Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide Combinations on Cognitive and Psychomotor Performance in Healthy Volunteers

The Acute and Residual Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide Combinations on Cognitive and Psychomotor Performance in Healthy Volunteers

The effects of remoxipride and chlorpromazine on eye movements and psychomotor performance in healthy volunteers

Fifteen healthy male volunteers received single doses of 100 mg immediate release remoxipride (IR), 150 mg controlled release remoxipride (CR), 50 mg chlorpromazine (CPZ), 2 mg lorazepam (LZ), and placebo in a randomised, five-period cross-over study. Both saccadic (SEM) and smooth pursuit eye movements (SPEM) as well as a battery of psychomotor performance tests were assessed at 1.5-h intervals over 9 h following drug administration. The areas under the response-time curves and the maximum effect during the study period were analysed by analysis of variance. The most consistent impairments were produced by LZ. The neuroleptics caused impairments to SEM, and tended to impair critical flicker fusion, continuous attention and both paced and unpaced versions of the digit-symbol substitution test as well as subjective measures of sedation. Only LZ impaired SPEM. Neither paced nor unpaced psychomotor tests distinguished between neuroleptics and benzodiazepines. The low therapeutic doses of IR and CR produced similar impairments to a sub-therapeutic dose of CPZ. Selectivity of pharmacological action does not appear to predict selectivity of effect on psychomotor function.

Psychomotor performance and counterregulatory responses during mild hypoglycemia in healthy volunteers.

The effect of mild hypoglycemia on psychomotor performance and counterregulatory responses was studied among 12 healthy volunteers. Each volunteer received two modified hyperinsulinemic glucose clamps. One morning, plasma glucose was held constant at euglycemic levels (4.9 mM) for 95 min, and another morning, it was lowered over 35 min and then held constant at hypoglycemic levels (3.4 mM) for 60 min. A battery of psychomotor tests and a questionnaire assessing hypoglycemic symptoms were administered before and repeated during the last 30 min of each clamp. The questionnaire and three selected psychomotor tests were also administered repetitively during the 1st h of each clamp. During the hypoglycemic studies, a rise was seen in plasma epinephrine and pancreatic polypeptide at 45 min. An increase in symptom scores was first recorded at 50 min during the hypoglycemic studies [median 4 (range 0-13) vs. 2 (5-6), P less than .05]. Performance was impaired on two psychomotor tests included in the battery. One was the trail making test on fine motor performance (-19.3 +/- 4.2 targets/min, mean +/- SE vs. 1.2 +/- 4.8 targets/min, P less than .05), and the other was the digit-symbol substitution (DSS) test on information processing and memory (18 +/- 3 vs. 29 +/- 4 symbols/min, P less than .03). Of the tests administered during the 1st h, performance was impaired on the DSS. This impairment became significant at 45 min (14 +/- 4 vs. 22 +/- 4 symbols/min, P less than .005). In conclusion, mild hypoglycemia selectively impairs psychomotor performance in healthy volunteers but not before the onset of glucose counterregulation and warning symptoms.

A double-blind, placebo-controlled clinical study on the effect of a standardized ginseng extract on psychomotor performance in healthy volunteers

Various tests of psychomotor performance were carried out in a group of 16 healthy male volunteers given a standardized preparation of Korean ginseng (G 115; 100 mg twice a day for 12 weeks) and in a similar group given identical placebo capsules under double-blind conditions. A favourable effect of G 115 relative to baseline performance was observed in attention (cancellation test), processing (mental arithmetic, logical deduction), integrated sensory-motor function (choice reaction time) and auditory reaction time. However, end performance of the G 115 group was superior statistically to the placebo group only in mental arithmetic. No difference between G 115 and placebo was found in tests of pure motor function (tapping test), recognition (digit symbol substitution) and visual reaction time. No adverse effects were reported. It is concluded that G 115 may be superior to placebo in improving certain psychomotor functions in healthy subjects.