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PubMed1979

The significance of personality traits in EEG evaluation of drug effects.

The relatively clear and compact picture of an electroencephalographic classification of psychotropic substances becomes extremely more complex if the influence of personality traits and topographic differentiations in the EEG are taken into account. Using the example of EEG alterations under diazepam, amitriptyline, pyritinol, EMD 21-657 and caffeine, the complex structure of substance effects, personality factors, topographical differentiations, placebo reactivity and spontaneous circadian variability of the EEG is demonstrated.

Amitriptyline↗
PubMed1994

Event-related potentials and psychopharmacology. Cholinergic modulation of P300.

The event-related potential P300 probably reflects the encoding of information into short-term memory. Anatomical structures of the limbic system are involved in this process. Since the same structures are involved in the generation of the event-related potential P300, P300 is thus well suited to assess pharmacological influence on memory functions and cognitive processes, for example, by changing the availability of neurotransmitters like acetylcholine at their respective receptors.

Adult↗
PubMed1992

Effect of pyritinol on EEG and SSEP in comatose patients in the acute phase of intensive care therapy.

The extent and duration of acute disturbances of consciousness depend on the severity and localization of the underlying cerebral dysfunction. The Glasgow Coma Scale (GCS) permits a relevant statement to be made on the course and recovery tendency of functional damage patterns in cerebral, mesencephalic, and brain stem structures. Therapy is directed at exerting a beneficial effect on the disturbed cerebral metabolism by administration of centrally active substances and at utilizing the available reserve plasticity of the brain for any possible recovery of mental performance. The bioavailability and profile of action of pyritinol have been well documented in animal experiments. We have studied the question as to the extent to which the substance influences the depth of coma in patients receiving acute intensive care therapy, and how this can be objectified electrophysiologically in the form of a specific central effect on basal brain structures. In a phase-II pilot study over five days the acute effect of intravenous 60-min. administration of 1,000 mg pyritinol on the depth of coma, the central conduction time (CCT) and the primary complex amplitude (N20/P25) of the SSEP, and on vigilance behavior (spectral edge frequencies and power) was investigated for 90 minutes in each case under intensive-medical steady-state conditions in 10 comatose patients. Because of the differences in the underlying brain damage, the primary depth of coma, age (30-89 years), sex (two female, eight male), as well as previous treatment (surgery, conservative), the significance of the results could not be evaluated by confirmatory statistical analysis.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1988

Effects of some metabolites of pyritinol (Encephabol) on ACH release from brain slices.

The K+ stimulated release of radioactively labelled ACH from cortical slices obtained from rats was increased by some pyridine derivatives that are metabolites of pyritinol. It appears that this effect is not mediated by an interaction with cholinergic receptors but may be related to the lipid solubility of the compounds. It is suggested that an effect of these metabolites on the membrane of nerve endings may be part of the mechanism by which pyritinol treatment increases ACH levels and release in old rats.

Acetylcholine↗
PubMed1986

Contribution to the search for vigilance-indicative EEG variables. Results of a controlled, double-blind study with pyritinol in elderly patients with symptoms of mental dysfunction.

We used a clinical pharmacological model to test pyritinol versus placebo in patients with mental deficiency and a clinical diagnosis of beginning chronic brain syndrome. Following a two weeks' washout phase, 50 patients were randomly allocated to two treatment groups of 25 patients each, receiving either 200 mg pyritinol three times daily, or placebo under double-blind conditions. The treatment period lasted 8 weeks. To be included in the study, patients had to have at least 50% subvigil phases in the 15-min EEG resting recording. We define such behaviour as a neurophysiological disturbance of vigilance. Scores in the Benton test were to be 2 points below the expected value, and/or the NAF score was to be above a standard value attained in an old peoples' home (greater than or equal to 14). We used this clinical pharmacological model for an internal validation of our Vigilance Index (VI). According to our definition, the Vigilance Index should express vigilance in the sense of an optimalization of the neuronal system to enable this system to perform better. The delta F power and the alpha slow-wave index have been considered as vigilance-indicative variables in the EEG. We believe that vigilance can be better expressed by a multidimensional approach, which takes into account all EEG elements that express vigilance, such as the replacement of the occipital basic rhythm (e.g. alpha or beta rhythm) into slow waves, the lowering of the dominant occipital frequency (be it an alpha or beta frequency), the anteriorization of the basic rhythm in the occipital field to the frontal region.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1986

On the effects of pyritinol on functional deficits of patients with organic mental disorders.

In 120 geriatric patients suffering from cerebral functional disorders with a moderate to rather severe degree of chronic brain syndrome, the effects of pyritinol were investigated in a placebo-controlled, randomized double-blind study. Furthermore, we attempted to find some evidence for the validity of a neurophysiological vigilance model which had already been used earlier. In the previous study it had been possible to show a rise in the vigilance level in patients under pyritinol treatment. The investigation began with a two-week single-blind placebo wash-out phase and continued over a 12-week treatment period, with six weeks' treatment in a hospital ward and six weeks' outpatient treatment (or in a geriatric home within a hospital setting). Pyritinol was administered three times daily in coated tablets each containing 200 mg. The course of the trial was controlled using two rating scales (SCAG, BGP), a physician's Global Impression (GI) and two performance tests (SKT, ZVT-G). There were 13 drop-outs, four because of intercurrent diseases, nine because they did not fulfill the inclusion criteria. The data of 107 patients were included in the statistical analysis, 54 on pyritinol and 53 on placebo. No notable adverse drug reactions were observed that were not similarly reported in the placebo group (Table 1). Statistically significant results were found in favor of pyritinol compared with placebo in both the level of clinical symptomatology (Fig. 1) and the performance level (Fig. 4). Particularly impressive was the superiority of pyritinol in the factor "social behavior" of the SCAG. Considering the clinical relevance of the changes it can be concluded that in both groups improvements occurred.(ABSTRACT TRUNCATED AT 250 WORDS)

Affective Symptoms↗
PubMed1982

Interaction of changes in hospital environment and neurotropic co-medication in chronic psychiatric inpatient. A placebo controlled double-blind study.

Chronic psychiatric patients (N = 42) predominantly diagnosed as schizophrenics, who had been hospitalized for the mean of 9 years were treated in a double-blind study with a neurotropic drug (tamitinol dihydrochloride coated tablets of 300 mg t.i.d.) and placebo. Test drugs were administered concomitantly to the existing drug therapy during two treatment periods of 6 weeks each with an interval of two months free of test medication. In the second treatment period patients moved to a new building. It was expected that neurotropic drug effects can be made clearer after the transfer requiring patient's reorientation in a new environment than before the transfer. Assessment of efficacy was made using observer ratings (Psychic and Somatic Findings of the A.M.P. System, WING Behaviour Rating Scale) and patient's self ratings (Adjective Check List. List of Somatic Symptoms) and clinical laboratory parameters. Results show that neurotropic co-medication reduced the "neurological syndrome" and the "psychoorganic syndrome" (A.M.P. System). An amelioration of the "neurological syndrome" was observed at the end of the first and at the end of the second medication phase (p less than or equal to 0.10) whilst the improvement of the "psychoorganic syndrome" was particularly evident as expected after the transfer to the new building (p less than or equal to 0.001) Patients receiving placebo described themselves as more active than patients receiving the test drug. (Adjective Check List: p less than or equal to 0.10). No subjective or objective side effects (List of somatic symptoms and laboratory parameters) were evident due to the test medication which was tolerated by all patients.

Adult↗
PubMed1993

Comparison of pyritinol and auranofin in the treatment of rheumatoid arthritis. The European Multicentre Study Group.

The efficacy and tolerability of pyritinol (PY) and auranofin (AU) were compared in a multicentre double-blind study. Patients with RA received 600 mg/day PY or 6 mg/day AU for 1 year. Response was rated by a defined improvement in at least four of the following: Ritchie index, joint swelling index, rating scales for pain and general well-being, functional index, morning stiffness, ESR. Of the 139 fully evaluable PY patients 61 (44%) dropped out due to adverse events or response failure compared with 44 (31%) of the 142 AU patients. In patients treated for 1 year efficacy parameters improved more in the PY than in the AU group, with significant differences for the general well-being (P = 0.022), ESR (P = 0.029) and haemoglobin (P = 0.0042). The response rate for PY (61/78 patients, 78%) was significantly superior to AU (58/98 patients, 59% P = 0.009). An intention-to-treat analysis corroborated this result (P = 0.030). Adverse events (AE) occurred in 64% of PY patients and in 58% of AU patients: main AE were mucocutaneous symptoms (PY 36%, AU 23%) and gastrointestinal complaints (PY 30% AU 37%). Single cases of proteinuria, hepatic and haematological abnormalities were noted in both groups.

Adult↗
PubMed1993

Activation PET as an instrument to determine therapeutic efficacy in Alzheimer's disease.

Forty patients with probable Alzheimer's disease (AD) were selected from a pool of 80 patients and assigned to 4 groups. Each received either social support, cognitive training only, or cognitive training in combination with pyritinol or phosphatidylserine. Treatment duration was 6 months. Before and after treatment the patients underwent neuropsychological testing as well as measurement of the regional cerebral metabolic rate for glucose using positron emission tomography (PET) and 2[18F]-fluoro-2-deoxy-D-glucose (FDG). Before treatment, the groups were comparable in respect to resting and activated glucose pattern achieved by a visual recognition task. They did not differ in scores of a neuropsychological test battery. After the treatment period the group with cognitive training + phosphatidylserine showed a significant glucose enhancement during the stimulation tasks in various brain regions, and an improvement in cognitive functioning compared to the other groups. The group with cognitive training + pyritinol had better stimulation effect as that of the social support group indicating that a combination of cognitive training + pharmacological intervention was superior than that of cognitive training alone.

Alzheimer Disease↗
PubMedDate not supplied

Long-term effects of phosphatidylserine, pyritinol, and cognitive training in Alzheimer's disease. A neuropsychological, EEG, and PET investigation.

70 patients with probable Alzheimer's disease were randomly allocated to four groups: 17 patients received only social support, 18 cognitive training twice a week, in 17 cognitive training was combined with pyritinol 2 x 600 mg/day and in 18 cognitive training was combined with phosphatidylserine 2 x 200 mg/day. Treatment duration was 6 months. Before and after treatment, the patients underwent neuropsychological testing as well as measurement of the regional cerebral metabolic rate for glucose using positron emission tomography and 18F-2-fluoro-2-deoxy-D-glucose. Before treatment the groups were comparable in respect to resting and activated glucose pattern achieved by a visual recognition task. Electrophysiological changes were assessed as EEG power, globally and in 4 frequency bands. This 6-month study in four groups of patients with Alzheimer's disease indicated that phosphatidylserine treatment has an effect on different measures of brain function. Since neuropsychological improvements were best documented after 8 and 16 weeks and faded towards the end of the treatment period, it must be concluded that this symptomatic therapy is mainly of short-term benefit and was overcome by the progressive pathological changes at the end of the treatment period.

Aged↗
PubMed1983

Treatment of the organic brain syndrome in the elderly. A double-blind comparison on the effects of a neurotropic drug and placebo.

100 inpatients of both sexes, most of them older than 65 years and suffering from symptoms of the organic brain syndrome (OBS), primarily associated with aging were included in a 6-week double-blind study. Patients were randomly assigned to two treatment groups of 50 patients each and received either a neurotropic drug (3 X 200 mg EMD 21657) or placebo coated tablets of identical appearance. Patients were evaluated at the beginning of the study and after 6 weeks of treatment using a physician's symptom rating, the Nurses' Observation Scale for Inpatient Evaluation ( NOSIE ), EEG, and a psychometric test battery to assess level of mental and memory functioning ( Rey test, Benton visual retention test, block design test by Kohs ). At the final assessment global response and overall tolerance were rated by the physician. The therapeutic effects of EMD 21657 were shown to be statistically significant compared to placebo in global response (p less than or equal to 0.05), in the factor 'cognitive disturbances' (p less than or equal to 0.05 doctor's symptom rating) and in the negative factors of the NOSIE (p less than or equal to 0.05). In the other parameters of the scales, the EEG and the mental ability tests no statistically significant changes could be demonstrated in the two groups after 6 weeks of treatment. The drugs were well tolerated. EMD 21657 treatment was interrupted because of side effects (increased aggressiveness, rash) in 2 cases.

Aged↗
PubMed1992

Therapeutic efficacy of pyritinol in patients with senile dementia of the Alzheimer type (SDAT) and multi-infarct dementia (MID).

This trial was performed to investigate the efficacy of pyritinol in the treatment of senile dementia. Initially, a total of 183 inpatients were screened for eligibility. Of 164 patients who met the inclusion criteria, 156 completed the trial. Allocation of the patients to the Senile Dementia of the Alzheimer Type group or the Multi-Infarct Dementia group was based on the Hachinski Ischemic Score, computed tomography scans and electroencephalographic (EEG) findings. In a 12-week double-blind treatment phase either 200 mg pyritinol dihydrochloride-monohydrate or placebo was given 3 times daily. Confirmatory statistics included item 2 of the Clinical Global Impression, the total score of the Short Cognitive Performance Test (Syndrom Kurz Test) and the factor 'cognitive disturbances' of the Sandoz Clinical Assessment Geriatric scale. In addition, data on tolerance, of EEG brain mapping and of a responder analysis were evaluated based on descriptive statistics. The therapeutic efficacy of pyritinol was clearly demonstrated by confirmatory analysis as the drug was statistically significantly superior to placebo in all 3 target variables. The clinical relevance of the outcome was underlined by the analysis of the descriptive variables and by the convergence found at the different observation levels. The EEG mapping demonstrated significant differences between placebo and pyritinol, with the latter decreasing slow and increasing fast alpha and beta activity, which reflects improvement of vigilance. Based on the results of this trial, it can be accepted that the therapeutic effect of pyritinol is superior to placebo in patients with mild to moderate dementia of both degenerative and vascular etiology.

Aged↗
PubMedDate not supplied

Psychopharmacological effects of pyritinol in normal volunteers.

Twelve healthy male volunteers received pyritinol 600 or 1,200 mg or placebo for 3 days according to a randomised, double-blind crossover design. On the 1st and 3rd days of each of the three treatment periods subjects completed a battery of psychological tests including Critical Flicker Fusion (CFFT), Choice Reaction Time (CRT), tests of memory and subjective drug effects at 1, 2, 4 and 6 h after dosing. Significant improvements in CFFT and CRT were found after pyritinol. There were no significant differences on the other tests, however, the observed enhancement in performance could be attributed to the effect of the drug.

Adult↗