Open AccessClinical Evaluation of the Daily Assessment of Symptoms‐Anxiety (DAS‐A): A New Instrument to Assess the Onset of Symptomatic Improvement in Generalized Anxiety Disorder
Author(s) -
Feltner Douglas E.,
Harness Jane,
Brock Jerri,
Sambunaris Angelo,
Cappelleri Joseph C.,
Morlock Robert
Publication year - 2009
Publication title -
cns neuroscience and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 69
eISSN - 1755-5949
pISSN - 1755-5930
DOI - 10.1111/j.1755-5949.2008.00075.x
Subject(s) - placebo , lorazepam , paroxetine , anxiety , generalized anxiety disorder , rating scale , hamilton anxiety rating scale , medicine , clinical endpoint , psychology , clinical trial , anesthesia , psychiatry , antidepressant , developmental psychology , alternative medicine , pathology
Rapid onset of symptomatic improvement is a desirable characteristic of new generalized anxiety disorder (GAD) treatments. A validated rating scale is needed to assess GAD symptoms during the first days of treatment. Aims: To provide clinical data to support the validation of the Daily Assessment of Symptoms‐Anxiety (DAS‐A), a new instrument to assess onset of symptomatic improvement in GAD. Methods: We assessed the ability of the DAS‐A to detect onset of symptomatic improvement during the first week of therapy in 169 GAD patients randomized to paroxetine 20 mg/day, lorazepam 4.5 mg/day, or placebo for 4 weeks. Results: On the primary outcome measure, average change from baseline over the first 6 days of DAS‐A assessments, lorazepam (−14.5 ± 1.8 [LS mean, SE]; P = 0.006 vs. placebo) showed a significant improvement versus placebo (−7.85 ± 1.7), whereas paroxetine (−8.3 ± 1.7; P = 0.83 vs. placebo) did not. Lorazepam produced a significant treatment effect on the DAS‐A at 24 h ( P = 0.0004), whereas paroxetine did not ( P = 0.5666). Both active drugs produced statistically significant improvement versus placebo on the DAS‐A total change score (last‐observation carried forward method; LOCF, endpoint). On the DAS‐A total change score (observed cases analysis), lorazepam produced statistically significant improvement versus placebo at weeks 1, 2, and 4 ( P < 0.05; no week 3 visit), whereas paroxetine, separated from placebo at weeks 2 and 4 ( P < 0.05). Both active drugs produced results on the Hamilton Anxiety Rating Scale (HAM‐A) at weeks 1 through 4 that were similar to those found on the DAS‐A. Conclusions: These data indicate that the DAS‐A can detect symptomatic improvement in GAD patients treated with lorazepam during the first week of treatment, and, in a secondary analysis, as early as 24 h.