A DOUBLE-BLIND, COMPARATIVE-STUDY OF DOTHIEPIN AND CLOMIPRAMINE IN THE TREATMENT OF MAJOR DEPRESSIVE-ILLNESS

Dothiepin, a well-established antidepressant, has been compared with c lomipramine in a single-blind study which demonstrated that dothiepin was better tolerated but: there was no difference in efficacy, The pre sent study was performed to recent European guidelines on good clinica l practice using a randomised, double-blind, parallel-group methodolog y One hundred and one patients suffering from major depressive disorde r as defined by DSM-III-R were randomised to receive either clomiprami ne (25-150 mg daily) or dothiepin (75-150 mg daily) for up to six week s, The clomipramine group comprised 51 patients, the dothiepin group 5 0 patients, At baseline, both groups had a mean age of 41-43 years and gave similar mean scores on the Hamilton Depression Rating Scale (23. 5 for clomipramine, 23.6 for dothiepin), At endpoint it was reduced in both groups but there were no significant differences between the gro ups (mean change from baseline for the clomipramine and dothiepin grou ps was -14.6 and -14.1 respectively), Thirty-one clomipramine patients and 41 dothiepin patients completed six weeks' treatment, Withdrawal from treatment (20 patients for clomipramine, nine for dothiepin) was significantly different (p=0.0105), When reasons for withdrawal were a nalysed, 13 clomipramine patients and two dothiepin patients withdrew because of adverse events, this difference being significant (p=0.002) , Thus both treatments were effective in treating patients suffering f rom major depressive disorder, but patients receiving dothiepin suffer ed fewer adverse events and were more likely to complete their treatme nt.