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To evaluate acute onset of anxiolytic activity using a dental anxiety model, 89 patients were randomised to double-blind single dose pregabalin 150 mg, alprazolam 0.5 mg or placebo 4 h before a scheduled dental procedure. A Dental Anxiety Total score >12 (moderate-to-severe) without meeting Diagnostic and Statistical Manual of Mental Disorders (Fourth edition) (DSM-IV) anxiety disorder criteria was required. Efficacy and safety, assessed 2, 2.5, 3, 3.5 and 4 h postdose, included 100 mm Visual Analogue Scale for Anxiety (VAS-Anxiety; primary outcome), 100 mm VAS-Sedation and Time-to-Onset of Action Scale (TOAS), a patient-rated anti-anxiety drug-benefit scale (no [0] to full benefit [10]). Mixed model analysis found significantly greater VAS-A improvement slopes for pregabalin (t = -2.47; P = 0.014) and alprazolam (t = -2.39; P = 0.018). There was a significant improvement versus placebo in the TOAS from 2 h through endpoint in alprazolam patients and from 3 h onward in pregabalin patients. Pregabalin produced significantly greater increases in VAS-Sedation versus placebo from 2.5 h through 4 h (2 h onward for alprazolam). Notably, there was a higher correlation between TOAS and VAS-Sedation (r = +0.58) than VAS-Anxiety (r = -0.50) on Spearman's analysis. The majority of Adverse Effects (AEs) were mild, and the most frequent for pregabalin, alprazolam, and placebo, respectively, were fatigue (N = 7, 7, 3), dizziness (N = 6, 3, 3), attention disturbance (N = 3, 1, 0), somnolence (N = 3, 0, 0), feeling abnormal (N = 0, 2, 0) and balance disorder (N = 0, 2, 0). These results suggest that onset of clinically meaningful anxiolytic effect after single-dose pregabalin occurs within the first 3-4 h. Additional research is needed to determine whether anxiolytic effect occurs in generalized anxiety disorder populations by day 1 or within 3-4 h post-first dose.

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The present study examined the effects of anti-oxidant vitamin supplementation on mood and cognitive functioning in 205 volunteers (110 females, 95 males; age range: 60-80 years). In this randomised, double-blind, placebo-controlled study, the volunteers received either anti-oxidant supplementation (daily dosage 12mg/d β-carotene, 400 mg/d α-tocopherol and 500mg/d ascorbic acid) or placebo. The volunteers were followed up for 12 months. Vitamin levels were assessed from plasma samples. The primary outcome measures were subjective mood, self-reported cognitive failures, and measures of intelligence. These were measured at 4, 8 and 12 months. There were very few significant differences between the placebo and vitamin groups. Analysis of the effects of changes in vitamin levels on mood and cognition revealed significant effects of changes in vitamin C but not the other anti-oxidants. Increases in vitamin C were associated at 12 months with more positive mood, greater improvements in global assessments of intellectual functioning and a reduction in everyday errors of memory, attention and action. These effects were greatest for those volunteers who had a more negative mood and lower levels of cognitive function at baseline. Overall, results support earlier findings based on examination of dietary intake.