Zimeldine versus amitriptyline in endogenous depression. A double-blind study with special reference to effects on liver function.

In a double-blind comparison of 21 inpatients with endogenous depression 225 mg zimeldine demonstrated the same degree of antidepressive efficacy as 150 mg amitriptyline after 4 weeks of treatment. Only "sleep disturbances" on the Hamilton Rating Scale for Depression (HRS) showed significant (P less than 0.05) improvement with amitriptyline. Only small differences in the frequency of side effects were seen. In the zimeldine group, increased sweating and headache were more pronounced, while the amitriptyline patients more often reported dry mouth and constipation. Body weight was not significantly changed by either treatment. In the zimeldine group, treatment had to be interrupted in three patients due to hypersensitivity reactions in the form of drug fever. Three other patients in the zimeldine group showed clinically significant elevation of liver enzymes. Hypersensitivity reactions and abnormal blood chemistry were both reversible. The adverse reactions are discussed, the cause of the occurrence remaining unknown.