Efficacy of tianeptine in anxious-depressed patients: results of a controlled multicenter trial versus amitriptyline.

265 adult outpatients with dysthymic disorder (DSM-III) associated with clinically manifest anxiety (according to FDA criteria) were included in a multicenter, randomized double-blind study. The trial consisted of three phases: placebo pretreatment phase and inclusion in the trial, treatment phase, placebo posttreatment phase. Patients were treated in monotherapy for 42 days with a mean dosage of 3 tablets per day corresponding to 37.5 mg/day of tianeptine or 75 mg/day of amitriptyline respectively. The following assessment instruments were used: the Montgomery and Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HARS), and the Check-List for the Evaluation of Somatic Symptoms of J.D. Guelfi and C.B. Pull (CHESS 82). Analysis of MADRS total scores showed an important and rapid improvement in tianeptine and amitriptyline groups, reaching statistical significance as soon as D7. At the end of the 6-week treatment period the tianeptine group reached a decrease of 64% in the initial MADRS total score versus 69% in the amitriptyline group. 78% of patients treated with tianeptine and 83% of patients treated with amitriptyline were considered as treatment responders. There was no difference in drop-out rates between the two groups. HARS scores showed a decrease in psychic as well as somatic anxiety in both groups. The action of tianeptine on anxious-depressive symptomatology was confirmed by the concomitant improvement of global clinical rating and patients' self-rating (HSCL). Statistical comparison of all clinical rating-scale scores in patients having completed the trial failed to show any significant group differences.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes