The tolerability of dothiepin: a review of clinical studies between 1963 and 1990 in over 13,000 depressed patients.
1. A total of 13,834 depressed patients were exposed to dothiepin most frequently at a dose of 150 mg/day and over 6 weeks, in 116 clinical studies between 1963 and 1990. 2. Overall, 2,066 (15%) patients were withdrawn prematurely from dothiepin for a variety of reasons, the most commonly specified reason being due to drug-related events in 500 (4%) patients. 3. In the remaining 11,768 patients, there were 9,312 reports of unwanted events most typically associated with the pharmacological effects of a tricyclic antidepressant although no serious sequelae were reported. 4. This review indicates that the incidence of serious adverse events associated with dothiepin at therapeutic doses is very low.
Donovan
S
S
Research Department, Boots Pharmaceuticals, Nottingham, England.
Dearden
L
L
Richardson
L
L
D002986:Clinical Trials as Topic; D003866:Depressive Disorder / Q000150:complications* / Q000188:drug therapy / Q000401:mortality; D004308:Dothiepin / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans
D004308:Dothiepin