The clinical efficacy of sertraline was studied in an open trial in 51 patients with Major Depression, according DSM-III-R criteria (37 female, 14 male), using imipramine as a reference drug. Patients were treated with sertraline (50-150 mg/day) or imipramine (150-250 mg/day). The treatment time was 6 weeks.
43% of patients receiving sertraline and 61% receiving imipramine significantly improved (difference is not significant). 11% of patients in sertraline and 24% of patients in imipramine groups recovered or showed a very good improvement respecting depressive signs and symptoms.
Clinical picture, severity of depression, episode duration, and positive history of antidepressive medication seemed to have no influence to sertraline efficacy, although somatic comorbidity had. There was no observable differences among two drugs in the dynamics of antidepressive action, both showing a similar clinical profile.
In the sertraline group the best effect was observed respecting depressive mood (improvement rate was 51 % in the day 42 vs 56% in the imipramine group), psychomotoric retardation (43% vs 55% respectively), and loos of activity (39% vs 46%).
Tolerability of sertraline was good (there was no adverse events in 57% of patients). Among most often observed adverse events were: sleep problems (26% of patients), and there was a need of appropriate co-medication in all cases, nausea (10%), epigastric troubles (4%), and tremor (4%). The significant psychiatric worsening was observed in three cases (symptoms of depression became most severe, eventually psychotic symptoms and/or tension emerged) leading to drop-out.
Anticholinergic adverse events were the most prominent group of problems in the patients receiving imipramine. Weight loss was often observed in sertraline group vs weight gain in imipramine.