Volume 8, Issue 4, December 2006

Editoral in Hungarian

Judit Tolna

New formulations of olanzapine in the treatment of acute agitation

György Bartkó

Abstract

Agitation is common in patients with acute schizophrenia or bipolar mania, and when severe can result in aggressive or violent behaviour. Pharmacotherapy for acute psychotic agitation includes the use of antipsychotic and benzodiazepine drugs, either alone or in combination. Although oral treatment is preferred, options in the pharmacotherapy of acute agitation include the parenteral administration of antipsychotics in order to facilitate onset of drug action and quickly alleviate symptoms. Until recently only conventional antipsychotic and benzodiazepine drugs were available as intramuscular injections. Olanzapine has been one of the first atypical antipsychotics available for intramuscular administration. Four randomized placebo and comparator controlled , double-blind clinical trials have demonstrated the efficacy of olanzapine in reducing acute agitation in patients with schizophrenia, bipolar mania and Alzheimer and vascular dementia. Evidence from these clinical trials has shown that IM olanzapine associated with faster onset of action and more favorable profile of adverse events, than monotherapy with IM haloperidol. Current clinical experience and one naturalistic study with intramuscular olanzapine suggest that it is efficacious and can be safely used in “real world” patients with severe agitation. Intramuscular olanzapine have shown ease of transition to same agent oral therapy once the acute agitation has diminished. The orally disintegrating tablet formulation of olanzapine was effective rapidly reducing psychopathology, while improving medication compliance, attitudes and behaviours. This new formulation of olanzapine may offer an alternative strategy in the treatment of acutely ill, noncompliant schizophrenic patients. Evidence suggests that the new formulations of olanzapine should be among the first-line choices in the treatment of agitation in acute psychosis. Keywords: olanzapine, intramuscular, orally disintegrating tablet, agitation, psychosis.

Keywords: olanzapine, intramuscular, orally disintegrating tablet, agitation, psychosis

Maintenance pharmacotherapy of schizophrenia: remission and the effectiveness of long-acting risperidone therapy

Andrea Sárosi

Abstract

Schizophrenia is a severe and devastating psychiatric disorder affecting about 1 percent of the world’s population, is characterized by psychotic episodes, negative symptoms and cognitive deficits. New advances in the understanding of schizophrenia etiology, course, treatment have increased interest in the development of consensus-defined standards for clinical status, improvement, remission and recovery. The introduction of standardized remission criteria may offer significant opportunities for clinical practice and clinical trials. Risperidone is the first atypical antipsychotic available in a long-acting injectable formulation. Clinical studies have demonstrated that long-acting risperidone is effective and well tolerated in patient with schizophrenia. Significant clinical improvement has been reported in patients switched to long-acting risperidone from other antipsychotic agents. Several patient groups (young, first episode, schizoaffective patients) have been shown significant benefit from long-acting risperidone. Special patient groups, including, the insufficient efficacy, the partial compliance, the suffering from side effect may benefit from treatment with long-acting risperidone. This treatment should improve the compliance and achieve remission and functional recovery.

Keywords: schizophrenia, remission, long-acting atypical antipsychotic.

The adverse effects of hallucinogens from intramural perspective

Ede Frecska, Luis E. Luna

Abstract

Very recently, after a long-lasting, worldwide moratorium on research of hallucinogenic agents, a good number of advanced countries have been revising their position, and start to approve testing the physiological and therapeutic effects of hallucinogens in human subjects. The purpose of this article is to review safety information available in the literature on hallucinogen use, and sort out those data from the reported complications of their abuse. Because of prohibitory regulations of the last 35 years, there are difficulties in achieving this kind of evaluation. Our approach has to be broad, and at times retrospective, in contrast to the well-controlled, focused, prospective design of the premarketing trials of legal drugs. The article summarizes the analyses in anticipation of supportive regulatory changes for the use of hallucinogens in well controlled studies and strictly supervised clinical trials. Keywords: adverse effects, ayahuasca, N,N-dimethyltryptamine, hallucinogenic agents, ibogaine, lysergic acid diethylamide, N-methyl-3,4-methylenedioxyamphetamine, psilocybin, therapeutic use.

Keywords: adverse effects, ayahuasca, N,N-dimethyltryptamine, hallucinogenic agents, ibogaine, lysergic acid diethylamide, N-methyl-3,4- methylenedioxyamphetamine, psilocybin, therapeutic use

Interaction between pharmacotherapy and psychotherapy – neurophysiologic basis

Tibor Magos

Abstract

Linking of pharmacotherapy and physiotherapy is considered the most effective approach in psychiatry of our days. While pharmacotherapy is mainly based on research of the monoaminergic systems, the focus of psychotherapy is on stress. The distinct neuronal mechanisms targeted by the two therapeutic modalities are in close affiliation with each other. The aim of this current paper is to highlight basic characteristics and conjunctions of these two systems and to pinpoint core interaction between pharmacotherapy and psychotherapy.

Keywords: monoaminergic systems, stress mechanism

Switching patients with schizophrenia to ziprasidone from conventional or other atypical antipsychotics

Gyorgy Bartko, Matyas Trixler, Istvan Bitter, Istvan Degrell, Janos Furedi, Gabor Faludi and the Ziprasidonra Váltást Vizsgáló Munkacsoport

Abstract

OBJECTIVES: The aim of the study was to assess the efficacy, tolerability and safety of ziprasidone in patients with schizophrenia who were already treated with conventional or other atypical antipsychotics that had to be switched due the lack of efficacy or bad tolerance.

METHODS: The study was a 12-week, open label, multicenter, non comparative trial on oral ziprasidone. 106 patients with DSM-IV schizophrenia were switched to ziprasidone from their previous antipsychotic without a washout phase. The study required fixed dosing with ziprasidone. For the first week the patient received 80 mg of study drug daily, followed for 3 weeks 120 mg/day. Subsequently for 8 weeks either 80 mg, or 120 mg, or 160 mg total daily dose could be given at the discretion of the investigator. Baseline and outcome assessment included Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Severity of Illness Subscale (CGI-S) and Global Improvement Subscale (CGI-I), Calgary Depression Scale (CAD), Hamilton Depression Scale (HAMD), Drug Attitude Inventory (DAI), Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) and Barnes Akathisia Rating Scale (BARS). Changes in overall body weight were also evaluated.

RESULTS: After 12 weeks on ziprasidone therapy, significant improvements were observed on all major symptoms measures and subscales. 34 (51,5%) patients (ITT) were rated much or very much improved on CGI-I at week 12. The mean SAS score significantly reduced during the ziprasidone treatment period (p<0.001). In the DAI ziprasidone treatment was also favorable rated. During treatment with ziprasidone for 12 weeks the body weight of the patients was significantly reduced (mean: 1,2 kg, SD=3,79, p=0.002). 58 adverse events occurred in 41 subjects (38.7%), of whom 7 patients (6.6%) encountered 9 severe adverse events. The adverse events were mainly mild and moderate. 15 patients (14.2%) were discontinued from the study due to adverse events. The reason for discontinuation in 4 cases was mainly insufficient clinical response.

CONCLUSION: Switching patients from their previous antipsychotic to ziprasidone without a washout phase was generally well tolerated and was associated with symptoms improvements 12 weeks later. At least 50% of patients who needed to be switched because of unsatisfactory efficacy or poor tolerance were significantly improved on ziprasidone therapy. The favorable safety profile of ziprasidone treatment was consistent with that seen in other clinical trials. Keywords: switching, ziprasidone, schizophrenia.

KEYWORDS: switching, ziprasidone, schizophrenia

Comparison between genes of Alzheimer's disease and brain tissue of others

Peter Gaszner, Laszlo Havas

Abstract

We have examined samples from 14 donors that were prepared from 44 different anatomical regions of the brain. These samples were prepared both as frozen and formalin-fixed, paraffin embedded . There were 310 frozen samples and 367 fixed samples. A total of 265 of the frozen samples were tested for RNA quality. A very high quality was obtained with 122 of these frozen samples (44%). The sample numbers were not large enough to draw conclusions about RNA quality for individual brain regions. Silver staining was performed on some samples and 5 of 7 samples tested from one donor diagnosed with Alzheimer’s like dementia showed evidence of Alzheimer’s disease by this method.

KEYWORDS: Alzheimer’s disease, brain samples, RNA, methods

Akathisia During Olanzapine Treatment

Zoltán Makkos, Andrea Csonka

Abstract

Olanzapine is a safely and comprehensively applicable atypical antipsychotic drug, for the treatment of schizophrenia, and of the mild to sever maniac episode. In our case study we describe the appearance of akathisia next to olanzapine therapy in the case of a 65 years old woman, and an overview of the literature have reference to adverse events of olanzapine.

KEYWORDS: olanzapine, akathisia, schizophrenia