CNS neuroscience & therapeutics
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Randomized Controlled Trial Multicenter Study
A multicenter, placebo-controlled, double-blind, randomized study of efficacy and safety of ocinaplon (DOV 273,547) in generalized anxiety disorder.
Preclinical studies demonstrated that ocinaplon, a positive allosteric modulator of GABA(A) receptors, possesses anxiolytic-like actions at doses devoid of the side effects typically associated with benzodiazepines. The aim of this study was to evaluate the effects of ocinaplon in a multicenter, double-blind proof-of-concept trial of male and female outpatients who met DSM-IV criteria for GAD with no coexisting depression, and had a baseline score of > or =20 on the Hamilton Scale for Anxiety (HAM-A). Patients with <20% reduction in HAM-A to placebo in a single-blind 7-day run-in period were randomly assigned to treatment with ocinaplon 90 mg t.i.d. (n = 31) or placebo for 28 days (n = 29). ⋯ The overall safety profile revealed no patterns of TEAEs, including those effects typically associated with other anxiolytic and/or benzodiazepine compounds, such as sedation. Ocinaplon appears to be a well-tolerated and effective treatment for GAD. It produces a rapid onset of anxiolytic action absent the side effects (e.g., dizziness, sedation) typically reported following anxiolytic doses of benzodiazepines.
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The association between migraine and psychiatric disorders has been reported in both clinical and epidemiological studies. The prevalence of psychiatric disorders has been found to be increased among individuals with migraine. Studies assessing migraine in psychiatric patients are limited and the majority of these studies have focused solely on examining patients with major depression. ⋯ This study suggests that there is an increased prevalence of migraine headaches among anxiety disorder patients as compared to the general population. Migraine comorbidity may have important clinical implications, such that the treatment of one condition could potentially ameliorate the development or progression of the other. Further research is required to better understand the nature and implications of the association between migraine and psychiatric disorders.