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Randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a new isoindoline derivative (DN-2327) in generalized anxiety

✍ Scribed by M. Linden; D. Hadler; S. Hofmann

Publisher: John Wiley and Sons
Year: 1997
Tongue: English
Weight: 113 KB
Volume: 12
Category: Article
ISSN: 0885-6222
DOI: 10.1002/(sici)1099-1077(199709/10)12:5<445::aid-hup887>3.0.co;2-2

No coin nor oath required. For personal study only.

✦ Synopsis

Generalized anxiety disorders are frequent, chronic, and disabling illnesses for which so far ideal drug treatment is not available. A new promising anxiolytic drug is DN-2327, a non-benzodiazepine isoindoline derivative, which has shown in animals to have anxiolytic, taming, antiaggressive, and anticonvulsive eects without relevant sedative properties, or signs of dependence. DN-2327 showed a higher anity for the BZ1-GABA receptor in comparison to diazepam or ¯unitrazepam. DN-2327 is rapidly absorbed with a t max of 2 . 4 h, both after single and multiple dosing. A steady state is reached after 2±3 days of treatment. The elimination half-life is about 8 h. A ®rst 4-week doubleblind comparative study between DN-2327 and placebo was conducted in 126 patients suering from generalized anxiety disorders, and treated as outpatients by general practitioners. The score of the Hamilton Anxiety Scale dropped signi®cantly from baseline to week 1 with further improvement until the ®nal visit after 4 weeks. Betweengroup comparisons are signi®cant from week 1 onward. Similar results were found with the self-rating KUSTA scale. Patients treated with DN-2327 reported more unwanted events, mostly dizziness and tiredness, than patients under placebo.

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