A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression.
| Autor: | Bennie EH; Leverndale Hospital, Glasgow, UK., Mullin JM, Martindale JJ |
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| Jazyk: | angličtina |
| Zdroj: | The Journal of clinical psychiatry [J Clin Psychiatry] 1995 Jun; Vol. 56 (6), pp. 229-37. |
| Abstrakt: | Background: Sertraline and fluoxetine have pharmacokinetic and pharmacologic differences, which may be of clinical relevance. Method: A randomized, double-blind, parallel-group study of 6 weeks' duration comparing the efficacy and safety of sertraline (50-100 mg/day) with those of fluoxetine (20-40 mg/day) was conducted in 286 psychiatric outpatients with DSM-III-R major depression or bipolar disorder (depressed). Primary efficacy measurements consisted of the 17-item Hamilton Rating Scale for Depression (HAM-D) and the Clinical Global Impressions (CGI) scale. Secondary measurements included the Hamilton Rating Scale for Anxiety (HAM-A), the Raskin Depression Scale, the Covi Anxiety Scale, and the Leeds Sleep Questionnaire. Additionally, scores for two items and five factors from the HAM-D were analyzed. Results: Efficacy was based on 124 evaluable patients in each treatment group. As measured by HAM-D and CGI-Severity scores, there was a significant (p < .001) improvement from baseline to each follow-up visit in both treatment groups with no statistically significant difference between groups. There was also no significant difference in the proportion of responders in each group. CGI-Improvement responder rates were 69% for sertraline and 67% for fluoxetine. Results of secondary efficacy measurements followed the same trend, although from the second week of treatment there was a numerical advantage (not statistically significant) for sertraline over fluoxetine in improving anxiety symptoms as measured by the total HAM-A score. Headache and nausea were the most frequently reported events for both drugs. The incidence of early patient withdrawals due to treatment-emergent adverse events was 14% for sertraline and 13% for fluoxetine. The starting dosage (sertraline 50 mg/day, fluoxetine 20 mg/day) was the final dosage in 76% of patients in both treatment groups. Conclusion: Sertraline and fluoxetine were equally effective and well tolerated in patients with major depression and associated anxiety. |
| Databáze: | MEDLINE |
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