Report on a double-blind comparison of two different regimens of dothiepin (prothiaden).

Thirty patients diagnosed as suffering from endogenous depression were entered into a 3-week double-blind trial comparing three times a day dosage of dothiepin with a single night-time dosage in a dosage range of 75 mg to 225 mg per day. The trial was conducted on in-patients and assessments were made pretrial and after 1 and 3 weeks. The patients were assessed by clinician-rated scales for psychomotor and psychic symptoms and by Zung's self-rating scale. Fifteen patients received dothiepin three times a day (day-time group) and fifteen received it as a single night-time dose (nocte group). There were two withdrawals in the day-time group and three in the nocte group. All withdrawals were due to lack of therapeutic effect. Over the 3-week trial 67% of the day-time group and 47% of the nocte group showed a clinical improvement. It was found that there was no statistically significant difference between the two methods of treatment. In the day-time group seven patients and in the night-time group nine patients suffered from side-effects. No particular pattern of side-effects emerged. There were no drug-related changes in the laboratory results. It was concluded that the therapeutic effect of both dosage regimes should be regarded as equivalent. Advantages, due to the specific action of dothiepin, compared with classical antidepressants for reference, could, however, not be presumed by the clinical impression.