E. Klieser

Randomized, double-blind, controlled trial of risperidone Versus clozapine in patients with chronic schizophrenia

&NA; This study compares the antipsychotic efficacy and the tolerability of risperidone and clozapine in patients with schizophrenia. Patients were randomized to double‐blind treatment with risperidone, 4 mg (N = 20), risperidone, 8 mg (N = 19), or clozapine, 400 mg (N = 20), daily for 28 days. Efficacy was assessed by improvement of psychotic symptoms, measured on the Brief Psychiatric Rating Scale, and Clinical Global Impression. The tolerability was assessed by the Simpson and Angus scale for extrapyramidal side effects (EPS), the Association for Methodology and Documentation in Psychiatry (AMDP) scale for somatic side effects, spontaneous reports of adverse events, clinical laboratory assessments, and vital signs. All treatments reduced psychotic symptoms. The global tolerability was significantly better in the risperidone than in the clozapine‐treated patients (p < 0.01). There were no differences between treatments on the AMDP scale. The most frequent spontaneously reported adverse effects were dizziness, fatigue, accommodation disturbance, and EPS in all treatment groups and increased salivation, mainly in the clozapine‐treated patients. Although there were no changes in vital signs during risperidone treatment, clozapine was associated with a mean reduction in heart rate of 10 beats/ minute. Risperidone tolerability at endpoint was classified as “very good” by 60 and 47% of patients treated with risperidone, 4 and 8 mg daily, respectively; the corresponding figure in clozapinetreated patients was 30%. The results suggest that risperidone is at least as effective as an antipsychotic as clozapine, providing a valuable new approach for the treatment of schizophrenia.

Risperidone versus clozapine in the treatment of schizophrenic patients with acute symptoms: A double blind, randomized trial

1. In order to verify the hypothesis that risperidone is a useful therapeutic alternative to clozapine the authors carried out a randomized double blind trial in 59 patients with paranoid hallucinatory psychoses. 2. In a treatment lasting 28 days three groups of patients received either 4 mg risperidone (N = 20), 8 mg risperidone (N = 19), or 400 mg clozapine (N = 20) daily. 3. The tolerance of 4 mg risperidone was globally assessed as being better than that of 400 mg clozapine. Drop-outs under clozapine were mostly caused by side effects, whereas under risperidone they tended to occur for therapeutic inefficacy. 4. The antipsychotic effect was highly significant and clinically relevant under both risperidone and clozapine.

Side effects of low dose neuroleptics and their impact on clinical outcome in generalized anxiety disorder

1. The present study was designed to determine the impact of neuroleptic side effects on clinical outcome in generalized anxiety disorder. 2. 205 outpatients entered the study. In an open label design fluspirilene 1.5 mg per week was administered for a period of 6 weeks. 3. Consistent with previous studies fluspirilene demonstrated again anxiolytic properties and was in general tolerated well. 4. However, in responders significantly less side effects were observed than in nonresponders. The interaction between tolerability and clinical outcome is the main finding of the present study. 5. In conclusion, the data suggest, that neuroleptic treatment of generalized anxiety disorder should be guided by paying more attention to potential side effects. If under neuroleptic treatment of generalized anxiety disorders side effects are observed, pharmacotherapy should be discontinued, because this fact predicts an unfavourable clinical outcome.

Test therapy in the treatment of generalized anxiety disorders with low dose fluspirilene

1. The present double-blind study was designed to determine under three different conditions (0.5 mg, 1.0 mg, 1.5 mg per week) whether response or non-response within a two-week test-therapy predicts clinical outcome after 6 weeks of fluspirilene treatment in generalized anxiety disorders. 2. 106 outpatients entered the study. The period of observation was 6 weeks. 3. Confirming previous reports of their study group the authors found a significant reduction of anxiety in all treatment groups. However, this effect was mainly observed with the highest dose administered. The main finding of the study is that there is a significant correlation between initial response after 2 weeks of test therapy and therapeutic success after 6 weeks in fluspirilene treatment of generalized anxiety disorders. 4. Decreases in somatic anxiety, psychic anxiety and Hamilton-total-score within the first 2 weeks correlate with the baseline-to-week 6 decreases of the corresponding item and with the global clinical assessment of efficacy after 6 weeks. 5. By means of test therapy patients with an unfavourable outcome are identified and, if medication is discontinued, are prevented from an ineffective longterm treatment.

Ärztliche und psychiatrische Weiterbildung als Mittel und Aufgabe der Qualitätssicherung

Therapeutisch erfolgreiche, wissenschaftlich begrundete, rechtlich zulassige und praktikable arztliche Tatigkeit setzt eine auf dem Ausbildungsstand grundende, zielorientierte Weiterbildung voraus. Eine entsprechende Weiterbildung kann hinsichtlich des erzielten Niveaus umso effizienter sein, je praxisrelevanter die vorangehende Ausbildung im Medizinstudium war.

Die Wirksamkeit von Fluspirilen bei unterschiedlichen Injektionsintervallen und kognitive Begleitwirkungen

In einer experimentellen Studie sollte die Wirksamkeit von Fluspirilen bei unterschiedlichen Injektionsintervallen untersucht werden, inwieweit nach einer 6wochigen Behandlung (1) eine weitere Befundbesserung zu erreichen ist und (2) unter welchen therapeutischen Bedingungen sich ein nach 6 Wochen erreichter Behandlungserfolg aufrecht erhalten last. Zusatzlich interessierte die Frage nach den kognitiven Begleitwirkungen einer solchen medikamentosen Behandlung.

Zur Wirksamkeit von Roxindol bei gehemmt depressiven Patienten

EMD 49980 (Roxindol) stammt aus der Gruppe der Indolalkylamine und wirkt selektiv agonistisch auf dopaminerge Autorezeptoren. Neuere Untersuchungsergebnisse deuten darauf hin, das Roxindol neben seinem Dopamin-D2-Autorezeptor-Agonismus zudem uber eine potente Wirksamkeit auf das serotonerge System verfugt.

Experimenteller Wirkungs- und Verträglichkeitsvergleich von Zotepin und Haloperidol bei akuter Schizophrenie

Das serotonin-antagonistische Neuroleptikum Zotepin wird wegen seiner ihm nachgesagten guten Vertraglichkeit zunehmend haufig angewandt, erstaunlicherweise wurde es aber bisher nur in wenigen Studien unter strikten experimentellen Bedingungen gepruft. In der hier vorliegenden Studie sollten die mit variablen Dosierungen verbundenen methodischen Probleme vermieden werden. Es wurden fixe Dosen von Zotepin und Haloperidol bei akut schizophrenen Patienten doppelblind verglichen, um das Nutzen-Risiko-Verhaltnis abzuschatzen.

31wöchiges, doppelblindes Einzelfallexperiment bei generalisierter Angststörung

Das Dilemma der Psychopharmakotherapie generalisierter Angststorungen besteht darin, das einerseits eine Reihe von Psychopharmaka zur Verfugung stehen, deren angstlosende Wirkung in Gruppenexperimenten gezeigt werden konnte [1], andererseits aber ein Mangel besteht an Pradiktoren des unter einer bestimmten Wirksubstanz zu erwartenden Behandlungserfolges im Einzelfall. Einen wichtigen Fortschritt in der Pradiktorenforschung markierte die Entwicklung des Probetherapie-Modells. Danach erlaubt die initiale Reaktion wahrend der ersten Therapiewoche eine Voraussage uber den Verlauf einer langerfristigen Behandlung.