Safety analyses vital signs

After a 5-week washout, the 12 subjects who took citalopram in the first part of the study received 10 mg of selegiline once daily for 4 d to compare the pharmacokinetics of selegiline with and without concomitant citalopram. The safety analysis showed no significant differences in vital signs or the frequency of adverse events between the study groups. Plasma prolactin concentrations... 

Hospital Anxiety and Depression Scale (HADS Zigmond and Snaith, 1983) and safety, monitored by evaluation of vital signs, laboratory and EKG assessments pre- and posttreatment, medications side-effects, and withdrawal symptoms, were conducted. Improvement was observed with both treatments, but no differences were found in the principal analysis. Post-hoc analyses revealed significant differences based on the severity of baseline anxiety, whereby kava was superior on the SARA in low anxiety and placebo was superior on the HADS and SARA in high anxiety. The treatments were well tolerated and there was no evidence of withdrawal or sexual side-effects. The authors concluded that although kava was not superior to placebo in this trial, it would be premature to rule it out as a possible treatment for GAD. 

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