"Alpidem"

A comparative study of alpidem, a nonbenzodiazepine, and lorazepam in patients with nonpsychotic anxiety. The use of benzodiazepines for generalized anxiety disorder (GAD) is a safe and effective treatment; however, their potential to produce dependence and impair psychomotor and cognitive functions is a drawback. In this study the efficacy and safety of alpidem, a nonbenzodiazepine, was assessed . Thirty patients who met DSM-III-R criteria for GAD were randomized to either alpidem (225 mg), lorazepam (4.5 mg), or placebo. The primary efficacy measure was the Hamilton Rating Scale for Anxiety (HAM-A). A repeated measures multivariate analysis of variance (MANOVA) was used to determine differences in HAM-A scores over time. The results showed a trend for alpidem to be more effective. Half

Studies with alpidem in normal volunteers and anxious patients. Alpidem, an imidazo-pyridine compound, has been evaluated as an anxiolytic in comparison with placebo and lorazepam. In the first of our normal volunteer studies, we compared single doses of alpidem, 25, 50 and 100 mg with lorazepam 2 mg and placebo on a range of cognitive, psychomotor and EEG variables. Lorazepam and the highest (100 mg) dose of alpidem impaired performance on a range of psychomotor tasks, the effects of the benzodiazepine being more severe and more prolonged. No impairment of performance was observed with the 25 and 50 mg doses. In the second study, the focus was on memory functions. Lorazepam, 2 mg, caused anterograde amnesia which was most apparent 1 h post-drug but persisted until 4 h: sedation

Effects of single doses of alpidem, lorazepam, and placebo on memory and attention in healthy young and elderly volunteers. The aim of the present study was to compare the effects of alpidem, a new imidazopyridine derivative with benzodiazepine-like anxiolytic effects, with those of lorazepam and placebo on memory and attention in two age groups of healthy volunteers. The study design was that of a randomized double-blind crossover trial with 12 young (18-30 years old) and 12 elderly (65-80) subjects. At weekly intervals, each subject was administered single oral doses of 25 mg alpidem, 50 mg alpidem, 1 mg lorazepam, and placebo in a randomized sequence. Computerized memory and attention tests were performed 90 minutes before and 320 minutes after drug administration. Lorazepam and alpidem 50 mg

Alpidem, a novel anxiolytic drug. A double-blind, placebo-controlled study in anxious outpatients. The anxiolytic activity of alpidem (150 mg/day) and its effects on psychomotor performances were compared with placebo in 60 outpatients. The trial was a double-blind, parallel group, and the two treatments were administered orally in three divided doses for 3 weeks. Eighteen male and 42 female (VAS), and clinical global impression (CGI). Psychomotor performance was assessed by the digit symbol substitution test (DSST). Alpidem was significantly more effective than placebo in decreasing the severity of anxiety, both in the physician's judgment [total HRSA (p = 0.007), psychic symptoms (p = 0.0040), somatic symptoms (p = 0.0002)] and in the patients' evaluation [STAI x 1 (p = 0.0001) and VAS

Pharmacokinetic and dynamic studies with a new anxiolytic imidazo-pyridine alpidem utilizing pharmaco-EEG and psychometry. In a double-blind, placebo-controlled study the pharmacokinetic and pharmacodynamic effects of a new imidazo-pyridine derivative, alpidem (SL80.0342) and the 1,4 benzodiazepine lorazepam were investigated utilizing quantitative EEG and psychometric testing. Ten normal volunteers received randomized (latin square) single oral doses of placebo, 25 mg, 50 mg and 100 mg alpidem and 2.5 mg lorazepam at weekly intervals. Blood level sampling, EEG recordings, evaluation of pulse, blood pressure and side-effects were carried out at 0, 1, 2, 4, 6 and 8 hours post drug; psychometric and psychophysiological investigations at the same time periods except for the first hour

A double-blind, placebo-controlled study of alpidem, a novel anxiolytic of imidazopyridine structure, in chronically anxious patients. In this double-blind study alpidem, a new imidazopyridine anxiolytic drug, was compared with placebo to assess its efficacy and safety in severely anxious patients at the fixed dose of 150 mg/day (50 mg t.i.d.) for 3 weeks. Fifty-nine patients with a score of at least 18 on the Hamilton Rating Scale for Anxiety (HRSA) entered the trial after a 3- to 7-day placebo run-in period. Symptom improvement was evaluated with the HRSA, the State and Trait Anxiety Inventory (STAI-1 and STAI-2), a Visual Analogue Scale (VAS) and the Clinical Global Impression (CGI). Alpidem was more effective than placebo in improving mean HRSA (total score and factorial scores

[Double-blind versus placebo comparison of single dose alpidem (50 mg or 75 mg) in a model of situational anxiety]. Alpidem (Ananxyl) is a new imidazopyridine anxiolytic. Two studies of single doses of alpidem (50 or 75 mg) versus placebo, involving 104 patients each, showed alpidem at these two doses to be effective in a human model for situational anxiety, which is the psychological state of patients awaiting cardiovascular examination or surgery. Clinical assessment showed no significant difference in safety between alpidem 50 mg and placebo. Conversely, at the dose of 75 mg, there was a higher incidence of drowsiness with alpidem than with placebo.

A comparative study of the interaction of alcohol with alpidem, lorazepam and placebo in normal subjects. Twelve healthy volunteers took part in a double-blind, cross-over comparison of the effects of lorazepam and alpidem on a battery of physiological, psychomotor and subjective tests before and after alcohol. Each subject received each treatment for 8 days and alcohol was given on day 8. Tests were carried out on days 1 and 4 and on day 8 before and after alcohol. Before alcohol the effects of alpidem on most tests were generally similar, but considerably less marked than those seen with lorazepam. There were some interesting differences between the two drugs in the effects on EEG and memory. In line with the effects seen with other anxiolytic drugs, lorazepam decreased the amplitude

Anxiolytics' effects on the actual driving performance of patients and healthy volunteers in a standardized test. An integration of three studies. Effects of benzodiazepine (diazepam, lorazepam) and benzodiazepine-like anxiolytics (alpidem, suriclone) and a 5-HT-3 antagonist (ondansetron) on actual driving performance were measured in three double-blind, placebo-controlled studies. Subjects were

Alpidem and lorazepam in the treatment of patients with anxiety disorders: comparison of physiological and psychological effects. The physiologcal and psychological effects of the novel imidazo-pyridine alpidem were compared with those of the benzodiazepine lorazepam in the context of a clinical trial. Twenty-three psychiatric out-patients with generalised anxiety disorder received alpidem (mean and produced significant impairment in the reaction time and memory tests whereas alpidem had no such effects. Alpidem therefore shows promise as an effective anxiolytic devoid of the adverse psychomotor and cognitive effects often associated with the benzodiazepines.

A randomized, double-blind study of alpidem vs placebo in the prevention and treatment of benzodiazepine withdrawal syndrome. The aim of the trial was to assess alpidem efficacy in preventing and treating the benzodiazepine (BZ) withdrawal syndrome (WS). A multicentre, double-blind, randomized versus placebo, parallel group study of six-week duration was carried out in outpatients suffering from generalized anxiety or adjustment disorder with an anxious mood and taking non-hypnotic BZ as continuous course of therapy of at least one-year duration. At the entry, the patients abruptly discontinued BZs and were treated with 50 mg/bid/tid of alpidem or placebo. Withdrawal syndrome diagnosis was (regarding treatment allocation) formulated by an independent psychiatrist, according to DSM-III-R

Comparison of the efficacy, safety and withdrawal of alpidem and alprazolam in anxious patients. We investigated whether a new non-benzodiazepine anti-anxiety drug, alpidem, produces weaker withdrawal symptoms than alprazolam. Under a double-blind procedure, 122 patients suffering from general anxiety disorders were randomly allocated to either alpidem (50 mg, three times a day) or alprazolam (0.5 mg, three times a day) for six weeks, followed by a two-week placebo withdrawal phase. The diagnosis of withdrawal syndrome (WS) was made, in blind conditions, on the basis of the Withdrawal Symptom Check List (WSCL), after one or two weeks of discontinuation of active treatment. The WS occurred significantly less frequently in the alpidem group (n = 10, 18%) than in the alprazolam group (n = 26

A comparison of alpidem and placebo in relieving benzodiazepine withdrawal symptoms. Chronic normal-dose benzodiazepine users requesting drug withdrawal were allocated to substitution with either the new anxiolytic alpidem (n = 13) or placebo (n = 12). During the first 2 weeks of the tapering programme, the dose of benzodiazepine was kept constant; for the next 2 weeks it was halved and half-dose alpidem (25 mg twice daily) or placebo substituted; for weeks 5 and 6, the benzodiazepine was discontinued and full-dose alpidem or placebo given; next alpidem or placebo were tapered to half-dose and then finally discontinued. Regular anxiety and tranquillizer withdrawal ratings were made. Nine of 12 patients given placebo withdrew successfully compared with four of 13 alpidem-treated patients. Anxiety

Effects of alpidem in anxious elderly outpatients: a double-blind, placebo-controlled trial. The efficacy and safety of alpidem, a new anxiolytic imidazopyridine, were compared with those of placebo in anxious elderly patients (65-80 years) by means of a randomized, double-blind, parallel group study. Following a 7-day "placebo run-in," 40 anxious patients were randomized to receive either alpidem or placebo. Daily doses ranging from 75 to 150 mg (25-50 mg t.i.d.) were administered for 3 weeks. Hamilton Rating Scale for Anxiety (HRSA), State Trait Anxiety Inventory (STAI-X1), Visual Analogue Scale (VAS), and Clinical Global Impression (CGI) were used on days 0, 3, 7, 14, and 21 for assessing efficacy. Psychomotor and mnesic performances were evaluated at the same time by means

Clinical pharmacokinetics and tolerability of alpidem in healthy subjects given increasing single doses. In a double-blind, placebo-controlled, cross-over experiment in 21 healthy male volunteers, aged 19 to 27 y, the pharmacokinetics and tolerance of the new anxiolytic drug alpidem (SL80.0342) and its three major metabolites were studied after single doses of 25, 50, 100 and 200 mg. Plasma concentrations of alpidem (in 20 subjects) and metabolites (in 6 subjects) were measured by HPLC over a period of 54 h after dosing. Cmax, tmax and AUC(0-54) and, when possible, t1/2 were determined for alpidem and metabolites and the dose linearity of the parameters was investigated. The time to peak of alpidem was dose independent in most subjects and was short (1-4 h); the mean values at the four dosing

Double blind, controlled study of the efficacy and safety of alpidem in the treatment of anxiety in schizophrenic in-patients. In this double-blind study, alpidem, a new imidazo-pyridine anxiolytic drug, was compared with placebo in order to test its efficacy and safety in chronic schizophrenic in-patients suffering from anxiety not directly related to the schizophrenic process. Sixty-six patients aged from 18 to 65 entered the trial. They also scored at least 18 on the Hamilton Rating Scale for Anxiety (HRSA) after a seven-day placebo run-in. Improvement in symptoms was evaluated by means of the HRSA, the Brief Psychiatric Rating Scale (BPRS), a Visual Analogue Scale (VAS), and the Clinical Global Impression score (CGI). Thirty-three patients were randomly allocated to alpidem and 33

Assessment of the interaction between a partial agonist and a full agonist of benzodiazepine receptors, based on psychomotor performance and memory, in healthy volunteers. Potential interactions between the imidazopyridine anxiolytic alpidem and the full benzodiazepine agonist lorazepam were assessed in a randomized, double-blind, four-way cross-over, placebo-controlled study in 16 healthy young male volunteers. Each volunteer received alpidem, 50 mg, or a placebo twice daily for 8 days with a 1- week wash-out interval. The interaction between alpidem, at the steady state, and a single oral dose of lorazepam 2 mg or a placebo was assessed after concomitant administration on days 7 or 9 of each treatment period. Psycho motor performance and cognitive function were evaluated before and 2, 4, 6