Additionally, the most commonly reported neuropsychiatric AEs in greater than or equal to 2% of subjects were: anxiety, agitation, depression, tension, depressed mood, sleep disorders, hostility and restlessness.Regarding the secondary endpoints, there were no differences between subjects on varenicline and placebo in psychiatric scales, including the Clinical Global Impression of Improvement (CGI-I), Clinical Global Impression of Severity (CGI-S), Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Scale (HAM-A), Barratt Impulsiveness Scale (BIS-11) and the Columbia Suicide-Severity Rating Scale (C-SSRS). Other safety endpoints were physical examination findings, vital signs and laboratory measures.
New Study With CHANTIX®/CHAMPIX® (varenicline) Tablets Suggests Favorable Benefit-Risk Profile In Adult Smokers With Major Depressive Disorder
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