Double-blind, placebo-controlled, multiple-ascending-dose study on the pharmacodynamics of ABIO-08/01, a new CNS drug with potential anxiolytic activity. 1. EEG mapping, psychometric and tolerability findings.

Abstract

In a double-blind, placebo-controlled, multiple-ascending-dose study, the encephalotropic and psychotropic properties of ABIO-08/01, a new potentially anxiolytic and nootropic isoxazoline, were studied in 16 young healthy males. In a randomized nonbalanced phase 1 study, they received 3 oral drug doses (10, 20, 40 mg) and placebo for 7 days (washout period 8 days). EEG mapping and psychometry were carried out at hours 0, 1, 6 of day 1 (acute effect) and day 5 (subacute and superimposed effects). MANOVA/ Hotelling T(2) test demonstrated significant central effects of ABIO-08/01 versus placebo after acute, subacute and superimposed administration of all doses in the resting, vigilance-controlled and eyes-open EEG. Univariate analysis revealed activating patterns in the resting EEG (40 mg > 20 mg > 10 mg), and sedative patterns in the eyes-open EEG (10 mg > 20 mg > 40 mg). In the vigilance-controlled EEG, 40 mg of ABIO-08/01 induced activating patterns, whereas 10 mg induced sedative patterns. Concerning psychometry, ABIO-08/01 improved concentration (40 mg > 20 mg > 10 mg; activating effect) and deteriorated well-being (10 mg > 20 mg > 40 mg; sedative effect). Ten milligrams also improved reaction time performance and psychomotor activity. ABIO-08/01 is well-tolerated and is of interest in anxiety disorders.

• Authors: Gerda M Saletu-Zyhlarz, Peter Anderer, Michael Wolzt, Heribert V Semlitsch, Alessandro Assandri, Paola Nessi, Fabrizio Nannipieri, Sergio Rosini, Bernd Saletu
• Journal: Neuropsychobiology (Neuropsychobiology) Vol. 59 Issue 2 Pg. 100-9 ( 2009) ISSN: 1423-0224 [Electronic] Switzerland
• PMID: 19365150 (Publication Type: Clinical Trial, Phase I, Journal Article, Randomized Controlled Trial)
• Copyright: 2009 S. Karger AG, Basel.

Chemical References

• ABIO 0801
• Anti-Anxiety Agents
• Isoxazoles
• Placebos

Topics

• Adult
• Anti-Anxiety Agents (administration & dosage, adverse effects, pharmacology)
• Anxiety Disorders (drug therapy)
• Brain (drug effects)
• Brain Mapping
• Dose-Response Relationship, Drug
• Double-Blind Method
• Electroencephalography (drug effects)
• Humans
• Isoxazoles (administration & dosage, adverse effects, pharmacology)
• Male
• Placebos
• Psychomotor Performance (drug effects)
• Time Factors