Objective: To assess the efficacy and tolerability of paroxetine 20mg daily, for the treatment of depression and depression associated with anxiety.
Method: An open, non-comparative study undertaken at three centers in three cities of Pakistan. A total of 112 in- or out-patients, presenting with a major depressive episode were included in the study. Depression was diagnosed according to DSM IV criteria and a Hamilton Rating Scale for Depression (HAMD-D) score of >18 on the first 17 items of the HAM-D-21. After a placebo washout period of 7 days, patients were given a 20-mg fixed dose of paroxetine daily in the morning for a period of 6 weeks. After baseline, regular assessments were made at 1, 2, 4 and 6 weeks. Efficacy measures included the HAMD-D, the Clinical Anxiety Scale, The Clinical Global Impression Severity of Illness Scale (CGI-S), and the Clinical Global Impression Improvement Scale (CGI-I). Tolerability was assessed by any adverse event. The primary therapeutic outcome measures were patients who achieved a 50% or greater reduction in HAMD-D score at the end of the treatment or achieved a reduction in final HAMD-D score of < or = 10 points. The final scores of 1 or 2 for CGI-S and CGI-I were considered as full clinical response.
Results: Of 112 cases evaluated, 57 were males and 55 females whose ages ranged from 18 to 65 years. There was a clear and statistically significant efficacy of paroxetine on all the major outcome variables. A total of 88% patients achieved a reduction in the final HAMD-D score at the end of treatment. The total HAM-D score reduced to 10 or less in 73% patients at 6 weeks and by this week 76% and 92% patients achieved a score of 1 or 2 for CGI-S and CGI-I, respectively. The mean Clinical Anxiety Scale score reduced from 12.6 at the baseline to 4.4 at the end of treatment. Safety data was evaluated in all 112 patients and paroxetine was well tolerated. Adverse events were experienced by 10% of patients of whom 4% were dropped from the study. Nausea was the commonest adverse event reported.
Conclusion: The study shows that paroxetine is an effective, well-tolerated, and safe drug for the treatment of depression.