ABSTRACT
BACKGROUND: This study compared the efficacy and tolerability of paroxetine with placebo in the treatment of panic disorder. METHOD: After three weeks of placebo, patients received 12 weeks of treatment with paroxetine (20, 40, or 60 mg) or placebo, and finally two weeks of placebo. Dosages were adjusted according to efficacy and tolerability. Standardised cognitive therapy was given to all patients. The primary measure of outcome was reduction in the number of panic attacks. RESULTS: Analysis of the results showed statistically significant differences in favour of paroxetine between the two treatment groups in two out of the three primary measures of outcome, i.e. 50% reduction in total number of panic attacks and number of panic attacks reduced to one or zero over the study period. For the third measure of outcome, the mean change in the total number of attacks from baseline, there was a positive trend in favour of paroxetine. The results of the primary measures of outcome were strongly supported by the results of the secondary efficacy measures of outcome. In addition, paroxetine, at all doses, was very well tolerated. CONCLUSION: Paroxetine plus cognitive therapy was significantly more effective than placebo plus cognitive therapy in the treatment of panic disorder.
Subject(s)
Panic Disorder/drug therapy , Paroxetine/therapeutic use , Selective Serotonin Reuptake Inhibitors/therapeutic use , Adolescent , Adult , Aged , Denmark , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Panic Disorder/psychology , Paroxetine/adverse effects , Selective Serotonin Reuptake Inhibitors/adverse effects , Treatment OutcomeABSTRACT
A total of 151 outpatients with endogenous or mixed endogenous and reactive depression were included in a 6-week double-blind study, with extension for up to 1 year, in psychiatric practice. The results showed trends in efficacy variables and a statistically significant difference in a benefit-risk ratio in favour of paroxetine (Seroxat, Paxil) compared with imipramine. Efficacy was largely maintained in both groups during long-term treatment. The frequency and severity of side effects in paroxetine patients declined markedly from short-term to long-term treatment, whereas changes in imipramine patients were less pronounced. Significantly more imipramine patients gained weight during long-term treatment. In conclusion, paroxetine is an effective and well tolerated antidepressant, well suited for outpatients in psychiatric practice.
