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E Klieser

Publications and source records attributed to E Klieser.

51 records · Page 3Linked to original sources

Antipsychotic efficacy of the dopaminergic autoreceptor agonist EMD 49980 (Roxindol). Results of an open clinical study.

EMD 49980 is a dopamine agonist with selective affinity to dopamine autoreceptors. Following pharmacological findings in animal studies, it was postulated that a hyperactivity of dopaminergic neurons, which is possibly present in acute schizophrenia, may be reduced by autoreceptor stimulation. To investigate the antipsychotic efficacy of EMD 49980, 20 acutely ill schizophrenics (ICD No. 295.3) were treated over four weeks with dosage increasing up to 3 mg or 9 mg. According to previously defined criteria four patients were clear responders, but clinically none of them revealed a full remission. Ten patients were nonresponders, and three of these patients were drop-outs because of marked deterioration of schizophrenic symptoms. The explorative analysis of BPRS subscales shows a statistically significant reduction of anxiety/depression and anergia, but no clear influence on the subscales THOT, HOST, and ACTV, which are the more specific scales for acute schizophrenia. EMD 49980 was subjectively well tolerated and there was no case of drug-induced extrapyramidal side-effects. In view of the only moderate antipsychotic efficacy in acute schizophrenia and the fact that antidepressant and anxiolytic effects were also observed, a clinical investigation of EMD 49980 in affective disorders and in schizophrenia with depression or anergia should be performed.

Acute Disease↗

Double-blind study of the therapeutic efficacy and tolerability of amitriptylinoxide in comparison with amitriptyline.

In a double-blind trial, 32 patients with endogenous or neurotic depression requiring drug treatment in hospital were randomly allocated to a four-week treatment with amitriptylinoxide or amitriptyline. The initial dosage was, in most cases, 60 mg b.i.d. for both drugs. During the first week of treatment, the dose was increased to a maximum of 300 mg/day with amitriptylinoxide and to 240 mg/day with amitriptyline, depending on tolerability and clinical impression. This dose was then maintained, if possible, throughout the following three weeks. During this period the mean dose of amitriptylinoxide was 167 +/- 8 mg/day, that of amitriptyline 166 +/- 8 mg/day. Seven of the 32 patients (three in the amitriptylinoxide and four in the amitriptyline group) discontinued the trial. Therapeutic efficacy was assessed by means of the AMDP system (scale 4), HAMD total scale, 4 HAMD subscales, and DSI and Bf-S scales. Tolerability was assessed using the AMDP system (scale 5) and a list of side-effects often associated with antidepressive drug treatment. With regard to therapeutic efficacy, no differences were noted between the two drugs except on the DSI scale. In contrast, there was a significant difference in tolerability--both in terms of the vegetative syndrome (AMDP) and the sum of side-effects--in favour of amitriptylinoxide.

Adult↗

Cognitive disturbances in neuroleptic therapy.

Eighteen patients (7 men, 11 women) from one of the centres taking part in a multicentre comparative study of remoxipride and haloperidol in the treatment of acute schizophrenia were investigated separately to study the effect of the two neuroleptic drugs on cognitive abilities. The tests of cognitive ability that were used are standard in West Germany. The results of this study indicate that there could be differences between remoxipride and haloperidol regarding their effects on cognitive abilities--the patients who had been treated for four weeks with remoxipride showed a greater "mental fitness".

Adult↗

A double-blind multicentre study comparing remoxipride, two and three times daily, with haloperidol in schizophrenia.

A double-blind multicentre study comparing the efficacy and safety of remoxipride in relation to haloperidol was conducted in 160 inpatients with schizophrenic illness diagnosed according to DSM-III. The study period was 4 weeks. The mean daily dose of remoxipride (whether given twice or three times daily) during the last week of treatment was 395 mg; the corresponding dose of haloperidol was 17 mg per day. No significant difference in therapeutic efficacy was found; Brief Psychiatric Rating Scale (BPRS) median total scores dropped from 41 to 20 (remoxipride twice daily, n = 51), 43 to 20 (remoxipride three times daily, n = 44) 40 to 19 (haloperidol three times daily, n = 48) at last valid rating. According to Clinical Global Impression (CGI) 68% in the remoxipride twice daily, 58% in the three times daily and 60% in the haloperidol group were very much or much improved. Treatment-emergent extrapyramidal checklist symptoms (hypokinesia, rigidity and tremor) were statistically significantly more frequent and more severe during haloperidol than during remoxipride treatment despite a statistically significantly higher concurrent use of anticholinergic drugs in the haloperidol group. Haloperidol treated patients reported more tiredness and drowsiness than remoxipride treated patients. Also, haloperidol treated patients had a significantly higher frequency of extrapyramidal symptoms on 8 out of 10 items of the Simpson and Angus scale.

Acute Disease↗

A double-blind multicentre study comparing remoxipride, controlled release formulation, with haloperidol in schizophrenia.

A double-blind multicentre study was undertaken to compare the efficacy and safety of remoxipride in a controlled release (CR) formulation given once daily with haloperidol twice daily in patients with schizophrenic illness. In total, 114 patients were included. All were diagnosed as schizophrenic or schizophreniform according to DSM-III. Their mean daily dose of remoxipride CR during the last week of treatment was 385 mg. In the haloperidol group the corresponding dose was 17 mg per day. The intended study period was 4 weeks with at least a one-day washout. No significant differences were found between treatments regarding efficacy variables. The median total Brief Psychiatric Rating Scale (BPRS) score was 40 in the remoxipride CR group at start of treatment and 21 at last valid rating. For the haloperidol group the corresponding figures were 40 and 22. Treatment-emergent extrapyramidal symptoms (Simpson and Angus rating) occurred statistically significantly more frequently and were more severe during haloperidol than during remoxipride CR treatment despite a statistically significantly higher concurrent use of anticholinergic drugs in the haloperidol group.

Acute Disease↗

The efficacy of Cavain in patients suffering from anxiety.

The therapeutical efficacy of Cavain should be proved in the treatment of patients suffering from abnormal anxiety, psychosomatic complaints and psychoreactive disorder. Thus two randomized groups of patients (26 each) were treated in double-blind technique with either 2 x 200 mg daily Cavain or placebo for a period of 28 days. Prior to the beginning of the investigations and within 14 days intervals the Hamilton Anxiety Scale (HAMA) and the Adjective Check List (Janke and Debus) were applied. The global therapeutical improvement and compatibility were documented after 14 and 28 days. A significant superiority of Cavain in comparison to placebo could be found. Cavain acted anxiolytically and promotive on the subjective vitality-related performance. Therapeutical conclusions are discussed.

Adult↗

Experimental examination of trazodone.

To establish the differential indication of trazodone and to find the predictors of its efficacy, we conducted a study in which 45 patients with major depressive disorder and 75 patients with acute schizophrenia were randomly assigned under double-blind conditions to either 400 mg trazodone daily, 150 mg amitriptyline daily, 20 mg haloperidol daily, or placebo daily. At the beginning of the investigations, numerous variables (basic data, MMPI, AMDP, HAM-A, HAM-D) were documented and evaluated on days 3, 7, 14, and 21. In our study, trazodone proved to be as effective an antidepressant drug as amitriptyline. In group comparison, no antipsychotic action of trazodone in schizophrenic patients could be proved. Yet the trazodone treatment was clearly of less risk than the amitriptyline treatment. Under trazodone, provocation of schizophrenic symptoms, which occurred numerously under amitriptyline, was found only in one patient out of 17 schizophrenics. Related to anamnesis and characteristics of the schizophrenic patient, a predictor-variable concerning the antipsychotic effect was not found. It can be assured, however, that patients with depressive symptoms (regarding the entity classification) respond to trazodone. After only 7 days of trazodone treatment, a relatively reliable decision can be established as to whether a therapeutical success can be expected if treatment is continued.

Adult↗

Experimental comparison between the effect of standardized trazodone-amitriptyline and placebo treatment in vitalized depressive patients.

We are performing a double-blind trial with inward psychiatric patients. The indication for our psychotropic or psychotherapeutic intervention is mainly severe depression (= major depressive disorders DSM III). For a 3-week trial course trazodone (400 mg daily), amitriptyline (150 mg/die) or placebo capsules were given at random. All patients received the same type of cognitive behaviour therapy. The test battery consists of CGI, BPRS, HAMD, HAMA and AMDP; adverse drug reactions are documented as "free reports" (= freier Nebenwirkungsbericht). The interim results (until March 1987) will be presented. Our investigation indicates that it is probable that the trazodone treatment we used is equivalent to corresponding amitriptyline treatment.

Adult↗

Study to establish the indication for the selective S2 antagonist ritanserin.

In our open study, ritanserin was shown to be an antidepressant low in side effects with a rapid onset of action. In contrast to the results reported by Ceulemanns, patients suffering from melancholia could also be treated with ritanserin. Similar to amitriptyline, ritanserin is able to provoke psychotic symptoms in schizophrenic patients despite the absence of an anticholinergic action. Ritanserin appears to improve mood and subjective well-being of depressive schizophrenic patients as supplementary therapy to a highly potent neuroleptic. This is consistent with the experience of Gelders. The relevance of the results described is restricted by the fact that the patients received an above-average intensive medical care besides the pharmacotherapy. In addition, the expectations of the patients with regard to ritanserin were extremely high and they expected an above-average effect of the ritanserin treatment.

Adult↗

Experimental comparison of the effectivity of individually adapted and standardized dosages of haloperidol.

Experimental tests of whether an individual neuroleptic treatment for compensation of acute schizophrenic disorders is more effective and has fewer side effects than a standard therapy were performed under double-blind conditions. For this purpose, a group of 16 patients was treated with 10 mg haloperidol/day for the duration of 14 days, and another group of 16 patients was treated with 20 mg haloperidol/day for the same period. 16 patients of a third group were treated for 14 days with an individual haloperidol dose adapted to the psychopathological findings. Patients were randomly allocated to the treatment groups. The medication was laid down in accordance with the randomization plan without informing the ward staff and raters by a leading physician of the hospital who was not involved in the data collection in the investigation. The psychological findings were registered by means of the BPRS and the global appraisal by the doctor (CGI) on days 0, 7 and 14. Extrapyramidal side effects were registered by means of the Simpson scale on days 0, 7 and 14. A superiority of the individually adapted treatment over standardized treatment could be demonstrated neither for the therapeutic target parameters nor for the side effect variables. On the contrary, a tendency to superiority in the groups treated with fixed doses was found. The results are discussed in terms of their significance for treatment practice.

Acute Disease↗

Comparing the effects of pimozide and placebo in a single case experiment.

A single case experiment as suggested by Edgington (1980) was carried out to answer the difficult question whether the continuation of treatment with neuroleptics was appropriate for a patient who still suffered from paranoia after inpatient treatment and continuous two-year administration of neuroleptics thereafter. A 24-weeks' experiment was arranged with the patient which was carried out under double-blind conditions. The experiment was planned in a way that it could be analysed with the help of a randomisation test. Physician's and patient's global ratings concerning the patient's condition and drug side effects were assessed weekly. In addition, psychopathological symptoms were measured by the Simpson-scale. Every week, the patient described her emotional state with the help of the Adjective Check List by Janke. Following the results of the experiment, medication was discontinued. This resulted in a distinct reduction of her complaints during a follow-up period of now 2 years. Although conducting single case experiments seems to be desirable for adequate problems, there are only few possibilities for practical application because of difficulties with planning and execution.

Female↗

Single case experiments in psychopharmacological trials.

Single case experiments have been used to make pharmacotherapeutic decision making more objective. 4 single case experiments are presented. In the case of 3 patients the question was whether flunitrazepam (Rohypnol) should be administered. In the 4th patient the issue was whether self-administration of Limbitrol (amitriptyline + chlordiazepoxide) should be terminated. Planning and analysis of these experiments was carried out by the randomization test.

Adult↗

Improved autonomic neurocardial balance in short-term abstinent alcoholics treated with acamprosate.

Standardized investigations on resting heart rate variability (HRV) should provide more information on acamprosate's human pharmacodynamic properties because acamprosate interacts with several neurotransmitter systems which are also involved in maintaining autonomic neurocardiac balance. We performed HRV measurements prospectively in 69 healthy controls and 19 chronic alcoholics to prove the hypotheses that: (1) compared to healthy controls, chronic alcoholics show disturbances in neurocardiac vagal function; and (2) in alcoholics, acamprosate treatment (6-8 days) should further decrease parasympathetic activity if acamprosate interacts with central gamma-aminobutyric acidA receptors in vivo. Cardiovagal dysfunction was initially present in 21% of the alcoholics. After treatment. however, their neurocardiac sympathetic-parasympathetic balance improved significantly.

Acamprosate↗

Sensitivity of carbohydrate-deficient transferrin (CDT) in relation to age and duration of abstinence.

Carbohydrate-deficient transferrin (CDT) serum concentrations were prospectively determined in 162 subjects (alcoholics n=62, controls n=100) using three different methods of detection (IEF, CDTect, Axis%CDT). Repeated testing in alcoholics after 3 and 5 days of abstinence demonstrated a significantly higher sensitivity of CDT in patients above 40 years of age compared to younger patients.

Adult↗