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Biomedical subjects

H Helmchen

Publications and source records attributed to H Helmchen.

At least 91 records · Page 5Linked to original sources
PubMed1978

[Ethical and legal problems in first clinical trials of psychotropic drugs (author's transl)].

Starting with the relevant national and international guidelines and legal regulations for clinical trials and with the distinction of therapeutical experimentation, therapeutical trial ("Heilversuch") and standard therapy the following points are discussed: a) informed consent in psychically ill patients with restricted capacity for stress and for insight and consent, b) consequences for insurances, c) advice and control for the researcher regarding the design, the performance and the judgment of the results of clinical trials of psychotropic drugs.

Age Factors↗
PubMed1977

[Frequency of depressive diseases (author's transl)].

Depressive diseases are among the most frequent illnesses. They are only partly recognized and treated. The largest number of depressed patients are found in the offices of the general practitioner and internist. Only a small fraction of patients with severe, predominantly endogenous psychotic depressions are treated in hospital. The following consequences arise from this frequency distribution: by improvement of diagnostic methods to recognize, if at all possible, all depressed patients requiring therapy and to treat them suitably; by improvement of prevention, primary in risk groups and tertiary in prophylaxis of recurrence, to lower the morbidity of depression; and by improvement of ambulant therapy with regard to controlling suicidal tendencies and anxiety and prevention of chronicity and resistance to therapy to reduce the necessity for hospitalization.

Adult↗
PubMed1976

Mianserin versus amitriptyline. A double-blind-trial evaluated by the AMP system.

Amitriptyline and mianserin were compared in a double-blind trial. Most of the depressive symptoms were influenced by both drugs, though quantitative and qualitative differences became evident. Amitriptyline predominantly influenced anxiety, despair and suicidal tendencies, while mianserin was particularly effective in psychomotor inhibition and the reduction of vegitative complaints. Mianserin did not show anticholinergic side effects.

Amitriptyline↗
PubMed1976

[Studies with the AMP system: comparison of symptoms from Berlin and Zürich].

Symptoms of 1830 psychiatric patients from Berlin and of 783 patients from Zurich were assessed using the AMP-system. The symptoms were analysed according to their frequency and their potency to differentiate diagnostic groups. The following 4 categories of symptoms proved to be useful: frequently occurring and specific or unspecific, rarely occurring and specific or unspecific. Factor analyses of the frequently occurring unspecific symptoms yielded three general dimensions, i.e., "depression", "disturbance of memory and thinking" and "hostility".

Evaluation Studies as Topic↗
PubMed1975

[The logic of decision in symptom rating (author's transl)].

The rating systems used in psychiatry consider sometimes different ways of classifying parameters, such as the valuability and the certainty of decision. Those two parameters have been analysed by means of the AMP-ratings of two samples (Berlin: 1879 patients, Zürich: 786 patients). We have found that the reply "not valuable" appears much less frequently than the reply "questionable valuable". For delusional symptoms and disorders of perception the certainty of decision is lowest. The various analyses carried out lead us to the conclusion that without loosing informatory value of any consequence we can renounce any separate documentation on valuability and certainty of decision.

Decision Making↗
PubMed1975

The inherent paradox of clinical trials in psychiatry.

The authors sum up the central issue of ethics in the conduct of controlled clinical trials in these two paradoxes: 'first, it is unethical to use treatment the efficacy of which has not been examined scientifically; second, it is also unethical to examine the efficacy of treatment scientifically.' In this paper they set out to demonstrate how these antithetical statements apply in controlled trials conducted in psychiatric patients. In such trials the problem of obtaining informed consent may be acute, but in these patients giving 'informed' consent might contribute to a further exacerbation of the illness. Nevertheless the problem cannot be evaded, and scientific judgments must be applied to treatment for it to be sound and improved for the further benefit of patients. These problems in the case of psychiatric controlled trials are a part of the methodology, and in Germany a new drug law has been drafted to attempt to clarify the issue. The authors briefly discuss its application, and its consequences if such a law were enacted. British psychiatrists have exactly the same problems to face but so far no attempts have been made to establish a legal framework.

Clinical Trials as Topic↗