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.
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.
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.
Gerda M
GM
Saletu-Zyhlarz
Peter
P
Anderer
Michael
M
Wolzt
Heribert V
HV
Semlitsch
Alessandro
A
Assandri
Paola
P
Nessi
Fabrizio
F
Nannipieri
Sergio
S
Rosini
Bernd
B
Saletu
D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*; D001008:Anxiety Disorders / Q000188:drug therapy*; D001921:Brain / Q000187:drug effects; D001931:Brain Mapping; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004569:Electroencephalography / Q000187:drug effects*; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*; D008297:Male; D010919:Placebos; D011597:Psychomotor Performance / Q000187:drug effects*; D013997:Time Factors
C529993:ABIO 0801; D014151:Anti-Anxiety Agents; D007555:Isoxazoles; D010919:Placebos