Sertraline is a selective serotonin reuptake inhibitor (SSRI) for which marketing
approval has been obtained recently in Germany. The results of several double-blind,
placebo-controlled studies have demonstrated that sertraline has a clear antidepressive
effect. However these studies have been conducted in outpatient populations. In the
context of this multi-center study, a total of 160 inpatients were treated with sertraline
50 - 150 mg or amitriptyline 75 - 225 mg over a period of 6 weeks in a double-blind
fashion. Sixty-two patients in the sertraline and 59 patients in the amitriptyline
group were evaluated for efficacy in the according-to-protocol (ATP) population; 80
sertraline and 75 amitriptyline patients were evaluated for safety in the Intention-to-treat
population (ITT). No statistically significant differences were detected between the
two groups in the efficacy analysis performed on the basis of the Hamilton Depression
Scale (HAM-D) total score and Clinical Global Impression (CGI). Due to its sedating
properties, amitriptyline was found to be significantly more effective with regard
to the HAM-D factor "sleep disturbance". The safety analysis, which was based on the
CGI, the global assessment at the end of study and a score for somatic adverse events
(FSUCL) revealed statistically significant advantages of sertraline over amitriptyline.
Amitriptyline was associated with more autonomic and circulatory side effects, while
epigastric complaints occurred more often with sertraline. The incidence of nausea
- a typical SSRI side effect - was the same in both groups.
