A DOUBLE-BLIND COMPARISON OF SERTRALINE AND IMIPRAMINE IN OUTPATIENTSWITH MAJOR DEPRESSION - ACUTE (8 WEEKS) AND CONTINUATION (16 WEEKS) TREATMENT

In a double-blind multicentre trial in patients with major depression, the efficacy and the tolerability of sertraline were compared to thos e of imipramine, during an 8-week acute treatment phase followed by a 16-week continuation treatment phase in treatment responders. A total of 104 patients who met DSM-III-R criteria for major depression, HAM-D 17-item greater than or equal to 18 and Raskin Depression score > Cov i Anxiety score, were randomized to receive either sertraline or imipr amine. The initial daily dosage of 50 mg of sertraline or imipramine w as rapidly titrated upwards in increments of 50 mg/day at weekly inter vals, tolerability permitting, to a maximum of 200 mg/day by the fourt h week. Eighty-eight patients completed at least 3 weeks of treatment and were included in the efficacy evaluable population. Both treatment groups demonstrated similar improvements on depression and anxiety ra ting scales during acute treatment, however, sertraline demonstrated s ignificantly more improvement relative to imipramine on the HAM-D and Covi Anxiety scales after 1 week of treatment. Sertraline was more eff ective (HAM-D 17-item, CGI-S, SCL-56 Total score, SCL-56 Depression sc ore, Covi Anxiety score) than imipramine in reducing depressive sympto ms at the end of 24 weeks of treatment. There were significant improve ments in all rating scales at week 24 relative to week 8 in the sertra line group but not in the imipramine group. The SCL-56 Total score, SC L-56 Depression score, Raskin Depression score and Covi Anxiety score at week 24 relative to week 8 showed significantly greater improvement in the sertraline group compared to the imipramine group. Imipramine was associated with a significantly higher incidence of dry mouth, swe ating, constipation, palpitations, and a significantly higher heart ra te and blood pressure. Sertraline was associated with a significantly higher incidence of diarrhoea/loose stools and insomnia. This study de monstrated a faster onset of therapeutic effect for sertraline relativ e to imipramine, reflecting the initiation of sertraline in a therapeu tic dose of 50 mg/day and the need for gradual titration of imipramine to a therapeutic dose, at the beginning of treatment. Although effica cy was similar in both treatment groups at the end of the 8 weeks of a cute therapy, sertraline-treated patients continued to manifest gradua l improvements in depressive and anxiety symptoms during the 16 weeks of continuation therapy such that sertraline-treated patients were sig nificantly more improved at the end of 24 weeks of therapy. (C) 1997 b y John Wiley & Sons, Ltd.