ADVERSE PSYCHIC REACTIONS TO PSYCHOTROPIC-DRUGS - A REPORT FROM THE AMUP STUDY

The AMUP study (AMUP = Arzneimitteluberwachung in der Psychiatrie (Dru g Monitoring in Psychiatry)) was conducted from 1979 to 1989 in order to provide for a systematic and standardized assessment of all adverse reactions to psychotropic drugs under the conditions of routine clini cal treatment at two psychiatric hospitals. This paper presents data f rom the AMUP study on the type and frequency of adverse psychic reacti ons to psychotropic drug groups and relevant single drugs. Psychic ADR leading to drug discontinuation were observed in 4.5 % of 15 264 inpa tients monitored over an eight-year period. Only neurological ADR were more frequent (4.9 %). Neuroleptics and antidepressants were involved with similar frequencies in ADR that were at least ''probably'' drug- related (3.3 and 3.5 %). Lithium salts and benzodiazepines were only r arely involved in psychic ADR. Toxic delirium (1.0 %), agitation (0.9 %), and sedation (0.8 %) were the most frequent single events, usually rated as ''probably'' drug-related. Depression and psychotic states w ere next in frequency, but judged as only ''possibly'' drug-related in a considerable proportion of cases. Haloperidol, the most common high -potency neuroleptic, was imputed mainly for depression, sedation, agi tation, and (malignant) neuroleptic syndrome; with medium-potency pera zine, toxic delirium and sedation prevailed; among the most common ant idepressants, amitriptyline was above all connected with toxic deliriu m, while with clomipramine agitation predominated. The paper discusses the particular difficulties encountered in the field of psychic ADR i n psychiatric patients regarding causality assessment, and emphasizes the need for continuous ADR assessment studies including state hospita ls.