[Methodological and theoretical aspects of the evaluation of psychotropic drugs in normal healthy volunteers (author's transl)]. 1977

G Debus

The paper points out that the current theories about the effects of psychiatric drugs in healthy human individuals is primarily a function of the methodological approaches applied in psychopharmacological research. Three approaches are distinguished: the diagnostic, the differential-psychological and the experimental-psychological approach. Within the diagnostic approach psychological-diagnostic instruments (e.g. tests) are considered to be able to measure specific effects of drugs (e.g. concentration). The differential-psychological approach takes into account inter- and intraindividual differences in psychological and psychophysiological variables (e.g. personality traits, actual state variables), which are responsible for the kind of drug effect on certain variables. The experimental-psychological approach typically studies drugs from the viewpoint of psychological theories concerning those psychological variables supposed to be affected by the drug (e.g. anxiety, attention). For each of these approaches the theoretical concept, the data gathering procedure, the kind of data interpretation, and the empirical adequacy are discussed. Meaning and usefulness of such terms as "Eigenwirkung", primary and secondary effect, main and side effect, and paradoxical effect are considered.

UI MeSH Term Description Entries
D011581 Psychological Tests Standardized tests designed to measure abilities (as in intelligence, aptitude, and achievement tests) or to evaluate personality traits. Parenting Stress Index,Trier Social Stress Test,Trier Stress Test,Psychologic Tests,Psychological Test,Test, Psychological,Tests, Psychological,Index, Parenting Stress,Psychologic Test,Stress Index, Parenting,Stress Test, Trier,Test, Psychologic,Test, Trier Stress,Trier Stress Tests
D011619 Psychotropic Drugs A loosely defined grouping of drugs that have effects on psychological function. Here the psychotropic agents include the antidepressive agents, hallucinogens, and tranquilizing agents (including the antipsychotics and anti-anxiety agents). Psychoactive Agent,Psychoactive Agents,Psychoactive Drug,Psychopharmaceutical,Psychopharmaceuticals,Psychotropic Drug,Psychoactive Drugs,Agent, Psychoactive,Agents, Psychoactive,Drug, Psychoactive,Drug, Psychotropic,Drugs, Psychoactive,Drugs, Psychotropic
D012107 Research Design A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly. Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D004644 Emotions Those affective states which can be experienced and have arousing and motivational properties. Feelings,Regret,Emotion,Feeling,Regrets
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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