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Gianfranco Placidi - One of the best experts on this subject based on the ideXlab platform.
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effects of treatment with Etizolam 0 5 mg bid on cognitive performance a 3 week multicenter randomized double blind placebo controlled two treatment three period noninferiority crossover study in patients with anxiety disorder
Clinical Therapeutics, 2009Co-Authors: Maria Pia De Candia, Guido Di Sciascio, Federico Durbano, Claudio Mencacci, Marta Rubiera, Eugenio Aguglia, Alessandra Garavini, Giuseppe Bersani, Antonella Di Sotto, Gianfranco PlacidiAbstract:Background: Etizolam is an anxiolytic drug with a pharmacologic profile similar to that of the classic benzodiazepines. Neurochemical research suggests that Etizolam may have selectivity for the subpopulation of γ-aminobutyric acid type A receptors associated with anxiety (ie, α1, β2, γ2). This property, plus its characterization as a ligand with fewer of the adverse events typical of full agonists (impaired cognitive function, tolerance, and dependence), led to its selection for this study. Objectives: The primary aim of this study was to test for the noninferiority of Etizolam 0.5 mg BID versus placebo in affecting cognitive function in patients with mild to moderate anxiety disorder of recent onset (<1 month). Anxiety measures and tolerability were also assessed. Methods: Patients between the ages of 18 and 65 years were eligible for enrollment. This doubleblind, placebo-controlled study was performed in 5 centers in Italy using a 2-treatment, 3-period crossover design. Patients were randomized to 3-week sequences of either Etizolam-placebo-placebo or placeboEtizolam-Etizolam. They were evaluated at 4 scheduled visits (screening and days 7, 14, and 21). Cognitive function was assessed using scores from the Wechsler Adult Intelligence Scale (WAIS) Digit Span test (total forward and backward scores and the time required to perform the test). Anxiety was measured using the Hamilton Anxiety Rating Scale (HAM-A) and the State-Trait Anxiety Inventory (STAI) for screening and to monitor adequacy of therapy. Blood pressure, heart rate, weight, and adverse events were also recorded. Results: A total of 77 white patients were enrolled (mean age, 33.3 years [range, 22–60 years]; 62.3% female; mean weight, 65.2 kg). With a power of 0.80, the difference between the effects of Etizolam and placebo on WAIS Digit Span performance was not significant for total score (0.102 [90% CI, –0.130 to 0.335]) or time required for completion (0.029 second [90% CI, –0.574 to 0.632]). Anxiety, as measured using the HAM-A and STAI instruments, did not differ significantly between groups. No significant differences were found between Etizolam 0.5 mg BID and placebo for cardiovascular events, weight changes, or
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Effects of treatment with Etizolam 0.5 mg BID on cognitive performance: a 3-week, multicenter, randomized, double-blind, placebo-controlled, two-treatment, three-period, noninferiority crossover study in patients with anxiety disorder.
Clinical Therapeutics, 2009Co-Authors: Maria Pia De Candia, Guido Di Sciascio, Federico Durbano, Claudio Mencacci, Marta Rubiera, Eugenio Aguglia, Alessandra Garavini, Giuseppe Bersani, Antonella Di Sotto, Gianfranco PlacidiAbstract:Background: Etizolam is an anxiolytic drug with a pharmacologic profile similar to that of the classic benzodiazepines. Neurochemical research suggests that Etizolam may have selectivity for the subpopulation of γ-aminobutyric acid type A receptors associated with anxiety (ie, α1, β2, γ2). This property, plus its characterization as a ligand with fewer of the adverse events typical of full agonists (impaired cognitive function, tolerance, and dependence), led to its selection for this study. Objectives: The primary aim of this study was to test for the noninferiority of Etizolam 0.5 mg BID versus placebo in affecting cognitive function in patients with mild to moderate anxiety disorder of recent onset (
Ramakrishna Raparla - One of the best experts on this subject based on the ideXlab platform.
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Novel extractive colorimetric and UV spectrophotometric estimation of Etizolam in bulk and tablet by forming ion association complex with methyl orange and bromocresol green
Toxicological & Environmental Chemistry, 2015Co-Authors: Prasenjit Mondal, A. Rama Narsimha Reddy, Gadapa Swarnamanju, Ramakrishna RaparlaAbstract:A novel, sensitive, and rapid UV spectrophotometric and colorimetric method was developed for estimation of Etizolam (ETZ) in bulk and tablet. The UV spectrophotometric method (method I) is based on quantitative estimation of ETZ using 0.1N NaOH as the solvent which exhibits maximal absorption at 378 nm. Colorimetric methods (method II and III) were based on the formation of color complex in association with ions between basic nitrogen of the drug with methyl orange (MO) and bromocresol green (BCG) in acidic medium. The formed color complexes were quantitatively extracted with chloroform and measured at 509 nm for Drug–MO complex and at 442 nm for Drug–BCG complex, respectively. Beer's law was obeyed over the linear ranges 2–16 µg/ml (method I), 5–45 µg/ml (method II), and 2–20 µg/ml (method III). The correlation coefficient (r2) for ETZ was 0.999, 0.997, and 0.998 for method I, II, and III, respectively. All methods were successfully applied for the assay of the drug in tablet. The % purity was found to ...
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a new validated simultaneous rp hplc method for estimation of escitalopram oxalate and Etizolam in bulk and table dosage form
Der Pharma Chemica, 2013Co-Authors: Prasenjit Mondal, B Santhosh, Sobha Rani Satla, Ramakrishna RaparlaAbstract:A reversed phase HPLC method has been developed for the simultaneous determination of Escitalopram oxalate and Etizolam by using C18 (250 x 4.6 mm) column and mobile phase of 0.02M Potassium dihydrogen orthophosphate: Acetonitrile (40:60) at 254 nm. Retention times of Escitalopram oxalate and Etizolam were 2.8 min and 4.1 min respectively with resolution of 6.52. This method shows to be linear (r2>0.99), precise (RSD<2%), accurate (recovery of 99.8% of Escitalopram oxalate and 99.46% of Etizolam), specific and robust. The Escitalopram oxalate contains in tablets was 99.8 % where Etizolam contains was 99.33 %
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A new validated simultaneous RP- HPLC method for estimation of escitalopram oxalate and Etizolam in bulk and table dosage form
2013Co-Authors: Prasenjit Mondal, Sobha Rani Satla, Santhosh. B, Ramakrishna RaparlaAbstract:A reversed phase HPLC method has been developed for the simultaneous determination of Escitalopram oxalate and Etizolam by using C18 (250 x 4.6 mm) column and mobile phase of 0.02M Potassium dihydrogen orthophosphate: Acetonitrile (40:60) at 254 nm. Retention times of Escitalopram oxalate and Etizolam were 2.8 min and 4.1 min respectively with resolution of 6.52. This method shows to be linear (r2>0.99), precise (RSD
Maria Pia De Candia - One of the best experts on this subject based on the ideXlab platform.
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effects of treatment with Etizolam 0 5 mg bid on cognitive performance a 3 week multicenter randomized double blind placebo controlled two treatment three period noninferiority crossover study in patients with anxiety disorder
Clinical Therapeutics, 2009Co-Authors: Maria Pia De Candia, Guido Di Sciascio, Federico Durbano, Claudio Mencacci, Marta Rubiera, Eugenio Aguglia, Alessandra Garavini, Giuseppe Bersani, Antonella Di Sotto, Gianfranco PlacidiAbstract:Background: Etizolam is an anxiolytic drug with a pharmacologic profile similar to that of the classic benzodiazepines. Neurochemical research suggests that Etizolam may have selectivity for the subpopulation of γ-aminobutyric acid type A receptors associated with anxiety (ie, α1, β2, γ2). This property, plus its characterization as a ligand with fewer of the adverse events typical of full agonists (impaired cognitive function, tolerance, and dependence), led to its selection for this study. Objectives: The primary aim of this study was to test for the noninferiority of Etizolam 0.5 mg BID versus placebo in affecting cognitive function in patients with mild to moderate anxiety disorder of recent onset (<1 month). Anxiety measures and tolerability were also assessed. Methods: Patients between the ages of 18 and 65 years were eligible for enrollment. This doubleblind, placebo-controlled study was performed in 5 centers in Italy using a 2-treatment, 3-period crossover design. Patients were randomized to 3-week sequences of either Etizolam-placebo-placebo or placeboEtizolam-Etizolam. They were evaluated at 4 scheduled visits (screening and days 7, 14, and 21). Cognitive function was assessed using scores from the Wechsler Adult Intelligence Scale (WAIS) Digit Span test (total forward and backward scores and the time required to perform the test). Anxiety was measured using the Hamilton Anxiety Rating Scale (HAM-A) and the State-Trait Anxiety Inventory (STAI) for screening and to monitor adequacy of therapy. Blood pressure, heart rate, weight, and adverse events were also recorded. Results: A total of 77 white patients were enrolled (mean age, 33.3 years [range, 22–60 years]; 62.3% female; mean weight, 65.2 kg). With a power of 0.80, the difference between the effects of Etizolam and placebo on WAIS Digit Span performance was not significant for total score (0.102 [90% CI, –0.130 to 0.335]) or time required for completion (0.029 second [90% CI, –0.574 to 0.632]). Anxiety, as measured using the HAM-A and STAI instruments, did not differ significantly between groups. No significant differences were found between Etizolam 0.5 mg BID and placebo for cardiovascular events, weight changes, or
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Effects of treatment with Etizolam 0.5 mg BID on cognitive performance: a 3-week, multicenter, randomized, double-blind, placebo-controlled, two-treatment, three-period, noninferiority crossover study in patients with anxiety disorder.
Clinical Therapeutics, 2009Co-Authors: Maria Pia De Candia, Guido Di Sciascio, Federico Durbano, Claudio Mencacci, Marta Rubiera, Eugenio Aguglia, Alessandra Garavini, Giuseppe Bersani, Antonella Di Sotto, Gianfranco PlacidiAbstract:Background: Etizolam is an anxiolytic drug with a pharmacologic profile similar to that of the classic benzodiazepines. Neurochemical research suggests that Etizolam may have selectivity for the subpopulation of γ-aminobutyric acid type A receptors associated with anxiety (ie, α1, β2, γ2). This property, plus its characterization as a ligand with fewer of the adverse events typical of full agonists (impaired cognitive function, tolerance, and dependence), led to its selection for this study. Objectives: The primary aim of this study was to test for the noninferiority of Etizolam 0.5 mg BID versus placebo in affecting cognitive function in patients with mild to moderate anxiety disorder of recent onset (
Fumihiko Sakai - One of the best experts on this subject based on the ideXlab platform.
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multi center randomized control trial of Etizolam plus nsaid combination for tension type headache
Internal Medicine, 2007Co-Authors: Koichi Hirata, Muneto Tatsumoto, Nobuo Araki, Takao Takeshima, Hisaka Igarashi, Koichi Shibata, Fumihiko SakaiAbstract:Objective: Benzodiazepines are commonly used for the treatment of tension-type headache (TTH), however, there are few randomized controlled trials recommending the use of these drugs in Japan. This study was undertaken to evaluate the efficacy of Etizolam, a thienodiazepine derivative, in combination with a non-steroidal anti-inflammatory drug (NSAID) as an acute treatment for TTH. Methods: The study design was a multi-center randomized control trial and included 144 patients. The diagnosis of TTH was based on the criteria of the International Classification of Headache Disorders-1 and all patients were diagnosed with episodic tension-type headache (ETTH). Changes in the severity of headache and shoulder pain were graded using a Visual Analogue Scale (VAS) before and after administration of drugs. Patients were randomized into NSAID alone (NSAID, mefenamic acid, 250 mg)group and NSAID (mefenamic acid, 250 mg) plus Etizolam (0.5 mg) (NSAID-ET) group prior to treatment. Results: Although both groups showed a significant drop in VAS for headache and shoulder pain (p<0.01), there was no overall significant difference between the NSAID-ET and NSAID groups. However, headache was improved significantly in female patients (p<0.05), and shoulder pain was improved in young and female patients (p<0.05, p<0.04) in the NSAID-ET group. Conclusion: This study indicates that the combination treatment of Etizolam and NSAID is useful in young or female patients.
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Multi-center randomized control trial of Etizolam plus NSAID combination for tension-type headache.
Internal Medicine, 2007Co-Authors: Koichi Hirata, Muneto Tatsumoto, Nobuo Araki, Takao Takeshima, Hisaka Igarashi, Koichi Shibata, Fumihiko SakaiAbstract:Objective: Benzodiazepines are commonly used for the treatment of tension-type headache (TTH), however, there are few randomized controlled trials recommending the use of these drugs in Japan. This study was undertaken to evaluate the efficacy of Etizolam, a thienodiazepine derivative, in combination with a non-steroidal anti-inflammatory drug (NSAID) as an acute treatment for TTH. Methods: The study design was a multi-center randomized control trial and included 144 patients. The diagnosis of TTH was based on the criteria of the International Classification of Headache Disorders-1 and all patients were diagnosed with episodic tension-type headache (ETTH). Changes in the severity of headache and shoulder pain were graded using a Visual Analogue Scale (VAS) before and after administration of drugs. Patients were randomized into NSAID alone (NSAID, mefenamic acid, 250 mg)group and NSAID (mefenamic acid, 250 mg) plus Etizolam (0.5 mg) (NSAID-ET) group prior to treatment. Results: Although both groups showed a significant drop in VAS for headache and shoulder pain (p
K. Otani - One of the best experts on this subject based on the ideXlab platform.
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Effects of genetic polymorphism of cytochrome P450 enzymes on the pharmacokinetics of benzodiazepines.
Journal of Clinical Pharmacy and Therapeutics, 2007Co-Authors: T. Fukasawa, A. Suzuki, K. OtaniAbstract:Pharmacogenetic studies have shown that several cytochrome P450 (CYP) enzymes exhibit genetic polymorphisms. Several benzodiazepines (BZPs) are metabolized predominantly or partly by polymorphic CYP2C19 and CYP3A4/5. The pharmacokinetics of diazepam, Etizolam, quazepam and desmethylclobazam have been shown to be affected by CYP2C19 polymorphism. The CYP3A5 polymorphism has been reported to affect the pharmacokinetics of alprazolam, but its effect on midazolam kinetics has been inconclusive. For Etizolam and desmethylclobazam, some data suggest that CYP2C19 deficiency leads to side-effects or toxicity. For the remaining BZPs the clinical significance of the observed pharmacokinetic changes remains unclear. Further studies on the effects of genetic polymorphisms of CYP enzymes on the pharmacokinetics and pharmacodynamics of BZPs are necessary to guide treatment individualization and optimization.
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Pharmacokinetics and pharmacodynamics of Etizolam are influenced by polymorphic CYP2C19 activity
European Journal of Clinical Pharmacology, 2005Co-Authors: T. Fukasawa, A. Suzuki, Y. Inoue, T. Tateishi, N. Yasui–furukori, K. OtaniAbstract:Objective To examine the effect of cytochrome P450 (CYP) 2C19 activity on the single-dose pharmacokinetics and pharmacodynamics of Etizolam. Methods The subjects were 21 healthy Japanese volunteers. The two mutated alleles (CYP2C19*2 and CYP2C19*3) causing absent CYP2C19 activity were identified by a polymerase chain reaction method. Twelve subjects were extensive metabolizers (EMs) with no or one mutated allele, and nine subjects were poor metabolizers (PMs) with two mutated alleles. The subjects received a single oral 1–mg dose of Etizolam, and blood samplings and evaluation of psychomotor function were conducted up to 24 h after dosing. Results The PMs had significantly larger total area under the plasma concentration–time curve (287±74 vs 178±122 ng·h/ml, p
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Pharmacokinetics and pharmacodynamics of Etizolam are influenced by polymorphic CYP2C19 activity
European Journal of Clinical Pharmacology, 2005Co-Authors: T. Fukasawa, N. Yasui-furukori, A. Suzuki, Y. Inoue, T. Tateishi, K. OtaniAbstract:Objective To examine the effect of cytochrome P450 (CYP) 2C19 activity on the single-dose pharmacokinetics and pharmacodynamics of Etizolam.
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Induction of the metabolism of Etizolam by carbamazepine in humans
European Journal of Clinical Pharmacology, 2005Co-Authors: S. Kondo, N. Yasui-furukori, T. Fukasawa, T. Aoshima, A. Suzuki, Y. Inoue, T. Tateishi, K. OtaniAbstract:Objective To examine the effect of carbamazepine on the single oral dose pharmacokinetics of Etizolam. Methods Eleven healthy male volunteers received carbamazepine 200 mg/day or placebo for 6 days in a double-blind, randomized, crossover manner, and on the sixth day they received a single oral 1-mg dose of Etizolam. Blood samplings and evaluation of psychomotor function by the Digit Symbol Substitution Test and Stanford Sleepiness Scale were conducted up to 24 h after Etizolam dosing. Plasma concentration of Etizolam was measured using high-performance liquid chromatography. Results Carbamazepine treatment significantly decreased the peak plasma concentration (17.5±4.1 ng/ml versus 13.9±4.1 ng/ml; P
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Induction of the metabolism of Etizolam by carbamazepine in humans
European Journal of Clinical Pharmacology, 2005Co-Authors: S. Kondo, N. Yasui-furukori, T. Fukasawa, T. Aoshima, A. Suzuki, Y. Inoue, T. Tateishi, K. OtaniAbstract:Objective To examine the effect of carbamazepine on the single oral dose pharmacokinetics of Etizolam.