A controlled comparison of sertraline and fluoxetine in acute and continuation treatment of major depression

Abstract In a double‐blind multicentre trial in patients with major depression, the efficacy and the tolerability of sertraline were compared with those of fluoxetine, during an eight‐week acute treatment phase followed by a 24‐week continuation treatment phase in treatment responders. A total of 165 patients who met DSM III‐R criteria for moderate to severe major depression were randomized to receive either sertraline or fluoxetine for short‐term and continuation treatment with initial daily dosages of either 50 mg of sertraline or 20 mg of fluoxetine. In the event of an inadequate response after 4 weeks of double‐blind therapy these doses could be doubled. Both treatment groups demonstrated similar improvements on both the Hamilton Rating Scale for Depression (HAM‐D) and the Montgomery and Asberg Depression Rating Scale (MADRS), during the acute phase as well as during the continuation phase. Both sertraline and fluoxetine were well tolerated, the most common side‐effects being gastrointestinal symptoms. Significantly more patients in the fluoxetine‐treatment group experienced activationg adverse events. The study demonstrates similar antidepressant efficacy and tolerability for sertraline and fluoxetine in acute and continuation treatment and equivalence of sertraline 50 mg daily with fluoxetine 20 mg daily in the treatment of depression.