1995, volume 11, issue 4
Stanisław Pużyński, Janusz Rybakowski, Paweł Gałuszko, Maria Beręsewicz, Elżbieta Bogdanowicz, Dorota Rosłoniec, Maria Chłopocka-Woźniak, Janusz Jakitowicz, Jan Jaracz, Antoni Kalinowski, Iwona Koszewska, Jerzy Landowski, Zbigniew Nowicki, Ewa Pilaczyńska, Łukasz Święcicki, Elżbieta Żelechowska-Ruda
Farmakoterapia w Psychiatrii i Neurologii, 1995, 4, 3-30
The clinical efficacy of sertraline was studied in an open trial in 51 patients with Major Depression, according DSM-III-R criteria (37 female, 14 male), using imipramine as a reference drug. Patients were treated with sertraline (50-150 mg/day) or imipramine (150-250 mg/day). The treatment time was 6 weeks.
43% of patients receiving sertraline and 61% receiving imipramine significantly improved (difference is not significant). 11% of patients in sertraline and 24% of patients in imipramine groups recovered or showed a very good improvement respecting depressive signs and symptoms.
Clinical picture, severity of depression, episode duration, and positive history of antidepressive medication seemed to have no influence to sertraline efficacy, although somatic comorbidity had. There was no observable differences among two drugs in the dynamics of antidepressive action, both showing a similar clinical profile.
In the sertraline group the best effect was observed respecting depressive mood (improvement rate was 51 % in the day 42 vs 56% in the imipramine group), psychomotoric retardation (43% vs 55% respectively), and loos of activity (39% vs 46%).
Tolerability of sertraline was good (there was no adverse events in 57% of patients). Among most often observed adverse events were: sleep problems (26% of patients), and there was a need of appropriate co-medication in all cases, nausea (10%), epigastric troubles (4%), and tremor (4%). The significant psychiatric worsening was observed in three cases (symptoms of depression became most severe, eventually psychotic symptoms and/or tension emerged) leading to drop-out.
Anticholinergic adverse events were the most prominent group of problems in the patients receiving imipramine. Weight loss was often observed in sertraline group vs weight gain in imipramine.
Janusz Heitzman, Katarzyna Wrzesień
Farmakoterapia w Psychiatrii i Neurologii, 1995, 4, 31-41
Maria Radziwon-Zaleska, Halina Matsumoto, Michał Skalski, Paweł Kunicki
Farmakoterapia w Psychiatrii i Neurologii, 1995, 4, 42-53
Therapeutic Drug Monitoring (TDM) should not only mean therapeutic drug measurement in blood and making the decision to which concentration range: therapeutic, subtherapeutic or toxic the result could be included. Monitored pharmacotherapy should mean the method of the optimalization of treatment concerning a particular patient which is realized according to the principles of the accepted model of management. During the process of TOM many factors are analyzed but the most important of them is the clinical status of the patient. Qualitative assessment of the efficacy and adverse side effects severity is provided to ascertain as quickly as possible the appropriate drug dosage.
Realization of TOM goals requires foundation or an interdisciplinary team. TDM service requires skillfulness to make use of various evaluation tools (as clinical as laboratory) and the art of the accurate interpretation.
On the basis of a sample of 15 patients with diagnosis of major depression treated with TCA a model of TDM is proposed.
Farmakoterapia w Psychiatrii i Neurologii, 1995, 4, 54-59
In order to test the changes of REM pattern in depression, 12 bipolar depressive patients were polisomnographicaly examined during amitryptiline treatment. Latency of REM sleep (LR), REM time (RT), REM density (RD), latency of eye movement (LEM) and mean latency of eye movement (M-LEM) were measured under 3 conditions: a) after 2 weeks wash out period (baseline), b) in 7th day of treatment with optimal dose of amitryptiline (125-300 mg/die), c) in 21st day of treatment with optimal dose of amitryptiline.
In comparison with baseline the significant prolongation of RL, LEM 1, M-LEM, decrease of RT and increase of RD in 7th day of treatment, as well as prolongation of LEM 1 and M-LEM in 21st day of amitryptiline treatment were found.
The result suggests that the influence of amitryptiline on REM sleep is complex and incompletely understood. The future researches with selective compounds are necessary.
Michał Skalski, Waldemar Szelenherger, Maria Radziwon-Zaleska, Halina Matsumoto
Farmakoterapia w Psychiatrii i Neurologii, 1995, 4, 60-69
Drugs, which change human behavior, modify neurons' metabolism and bioelectric activity. This was the first notion that led to developing of pharmaco-eeg. Main objects of this method are: description of changes caused by various drugs, objective classification of psychotropic medications, foreseeing possible effect of new drugs on CNS and helping in therapy. Parietal and occipital leads are most frequently used in pharmaco-eeg studies.
Fifteen patients -10 female, 5 male (mean age 52 years, 27-78 years), all meeting DSM-III-R criteria of major depression were included into this study. For one week before the study patients did not receive any antidepressive drugs. EEG recordings were made seven times during the study: before medication, 3 and 24 hours after the first dose and after 2, 4, 6, 8 weeks of therapy. Bach patient was evaluated clinically according to the following scales: Hamilton Depression Rating Scale (HDRS), Hamilton Anxiety Rating Scale (HARS), Global Impression Scale (GIS) and authors' own Side Effects Scale (SE). Blood levels of TCA's and theirs metabolites were measured by means of FPIA method IDx Abott. In part of the patients hydroxylation phenotype was established before the study, using debrysoquine as a model drug. EEG was recorded from P3-01 and P4-02 for about ten minutes. Artifacts were eliminated visually. Relative Power spectra were obtained by Fast Fourier Transform (FFT) and were calculated for EEG bands. Final profiles were calculated as changes between relative power for each EEG rhythm in each recording in comparison with recording made prior to the study.
Following results were found: significant relationship between therapeutic blood level of TCA and antidepressive EEG profile (chi 2 = 15.8, p=0.00007); significant correlation between an increase in beta 2 power and therapeutic blood level of TCA (for P4-02: Pearson r = 0.43, p < 0.001; for P3-01: Pearson r = 0.38, p <0.001); significant correlation between beta 2 power and TCA's blood level (for P4-02: Pearson r = 0.33, p < 0.01; for P3-01: Pearson r = 0.42, p < 0.00l); antidepressive profile of EEG correlated significantly negatively with scores in clinical scales; scores in HDRS and GIS scales correlated negatively with power spectra in beta 2 band in P4-02 (HDRS Pearson r = 0.31, p < 0.0l; GIS r = 0.31, p < 0.01). There was no significant correlation between beta 2 power and HARS and SE scores. Analysis of individual cases revealed that 2 patients, which did not improve during treatment, despite therapeutic blood levels of TCA, did not show antidepressive profile of EEG.
Pharmaco-eeg is helpful in answering the question if the dose is relevant, and the drug is being well absorbed and metabolised and if it has any influence on the CNS. Results from patients are not as unequivocal as data from a healthy population. This may be due to more pronounced group heterogeneity, commonly occurring polypragmatic drug use and adaptation to pharmaceutic agents. Despite such restrains pharmaco-eeg is the most sensitive physiological method of evaluating course and efficacy of psychotropic medication. Our results let us hope that in the near future it may be a very helpful method in forecasting individual clinical outcome.
Wiktor Dróżdż, Paweł Przybyłowski, Marcin Ziółkowski, Janusz Rybakowski
Farmakoterapia w Psychiatrii i Neurologii, 1995, 4, 70-76
The aim of this preliminary study was comparison of quantitative EEG pattern of schizophrenic patients treated with neuroleptic drugs with that of matched healthy control subjects. Gender differences of quantitative EEG patterns were found both in schizophrenic patients and healthy subjects. The di1Terences of EEG pattern between schizophrenic patients and control subjects were evidenced mainly in frontal areas. The influence of type of neuroleptic on EEG spectral analysis results in schizophrenic patients was confirmed. The increasing of interhemispheric asymmetries of brain electric activity was observed in male and female schizophrenic patients and in male healthy subjects.
Hubert Kowalczys, Szymon Niemcewicz, Jacek Drojewski, Wojciech Androsiuk
Farmakoterapia w Psychiatrii i Neurologii, 1995, 4, 77-82
In this paper preliminary, results of high doses intravenous Piracetam in the treatment of dementia and actigraphic monitoring are discussed. During course of i.v. Piracetam (12 g daily) and following period of 4.8 g Piracetam p.o. no side effects were observed. Patients showed improvement in c1inical scales (Information-Memory-Concentration Test, Mini-Mental State Examination). Actigraphic results showed increased motor activity after treatment, equally distributed for both day and night.