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PubMed2000

Zuclopenthixol acetate in psychiatric emergencies: looking for evidence from clinical trials.

BACKGROUND: Case series and reviews have suggested the effectiveness of zuclopenthixol acetate in the acute management of disturbed behaviour caused by serious mental illnesses. This review investigates the trial-based evidence for these suggestions. METHODS: All randomized clinical trials comparing zuclopenthixol acetate to other 'standard' treatments for the acute management of those with serious mental illnesses were identified and, if possible, their results summated. RESULTS: Six trials were identified. All had methodological problems and one did not meet the minimal methodological inclusion criteria. The summary data do not demonstrate that zuclopenthixol acetate is better than 'standard care' for altering behaviour, decreasing the need for supplementary medication, avoiding side-effects, or postponing early discharge against medical advice. One trial, however, presented data that suggested an earlier, more intense level of sedation. CONCLUSIONS: Recommendations of reviews and open studies for the use of zuclopenthixol acetate in preference to 'standard' treatments in the psychiatric emergency are not supported by evidence from randomized controlled trials.

Adolescent↗
PubMed2004

Effects of low-dose risperidone and low-dose zuclopenthixol on cognitive functions in first-episode drug-naive schizophrenic patients.

BACKGROUND: Studies on the effects of antipsychotics on cognitive deficits in schizophrenia mostly suggest a superior effect of atypical over typical compounds, although findings are inconsistent and effect sizes small. Several methodological issues, such as heterogeneous patient samples, incomparable drug doses, effects of prior medication, construct validity, and retest effects on neuropsychological tasks, confound most results and the comparability between studies. Consequently, the conclusion concerning effects of antipsychotics on cognition is still equivocal. OBJECTIVE: The present randomized clinical trial examined the effects on cognition of comparatively low doses of a typical antipsychotic (zuclopenthixol) and an atypical antipsychotic (risperidone) in a homogeneous group of drug-naive first-episode schizophrenic patients in a longitudinal setting. METHODS: First-episode schizophrenic patients who had never previously been exposed to antipsychotic treatment (N=25) were randomly allocated to treatment with flexible doses of zuclopenthixol or risperidone in an open-label design. Cognitive functions were examined both when patients were drug-naive, and after 13 weeks of treatment. A comprehensive neuropsychological battery was used in order to optimize construct validity, and principal components of cognitive functions were extrapolated in order to reduce type I errors. A healthy control group was tested at baseline and after 13 weeks, in order to examine retest effects. The cognitive domains studied were executive functions, selective attention, and reaction time. RESULTS: The patients showed considerable cognitive deficits when drug-naive. There were few differential effects of risperidone and zuclopenthixol on cognitive deficits, except for a differential significance, respectively, tendency towards improved reaction and movement times in the risperidone group, and a lack of such in the zuclopenthixol group. These differences were no longer significant after covarying for extrapyramidal side effects and anticholinergic medication that were more prevalent in the zuclopenthixol group and the increases after medication were comparable with retest effects in controls. CONCLUSION: The study underscores the importance of examining impact of factors, such as clinical improvement, extrapyramidal side effects, anticholinergic medication and retest effects in longitudinal efficacy studies. This study does not support efficacy of either risperidone or zuclopenthixol on cognitive functions in drug-naive schizophrenia patients after 3 months of medication, because neither could be distinguished from retest effects of the healthy control group.

Adult↗
PubMed2001

Dimensionality, responsiveness and standardization of the Bech-Rafaelsen Mania Scale in the ultra-short therapy with antipsychotics in patients with severe manic episodes.

OBJECTIVE: Typical antipsychotics have their indication in the ultra-short (first week) treatment of severe episodes of mania. In this setting the Bech-Rafaelsen Mania Scale (MAS) was psychometrically compared with the Clinical Global Impression scale (CGI) to assess its ability to measure response. METHOD: Ratings on patients with marked to severe mania (n = 80) who participated in the clinical trials to evaluate the ultra-short antimanic effect of zuclopenthixol acetate were assessed. The MAS was analysed for internal validity (total score a sufficient statistic) and for external validity. RESULTS: The MAS was shown to have a high internal validity showing onset of action already after days of treatment. After 6 days of treatment 53% of the patients responded according to the MAS but only 30% according to the CGI. The difference was statistically significant. CONCLUSION: The MAS has been found to be a valid scale to measure early onset of action and response in the ultra-short antimanic treatment with typical antipsychotics.

Aged↗
PubMed2000

Acquired haemophilia in recipients of depot thioxanthenes.

We present two cases in which the occurrence of acquired haemophilia is associated with the use of depot preparations of the thioxanthenes zuclopenthixol and flupenthixol. These drugs have not previously been implicated in the aetiology of acquired haemophilia.

Adult↗
PubMed2000

Akathisia masked by hypokinesia.

Here, we will discuss the concept of subjective akathisia and present a patient case. Our patient was suffering from neuroleptic-induced hypokinesia and akathisia at the same time. The typical motor manifestations of akathisia were masked by hypokinesia, which made the diagnosis difficult. However, the subjective symptoms of akathisia were evident and distressing. Although not observable to bare eye, the pathognomonic pattern of motor activity detected in akathisia was demonstrated by actometric recording. Changing the conventional neuroleptic to an atypical one brought relief to the subjective symptoms of akathisia and hypokinesia, while the motor activity was clearly diminished in actometric recording. Actometric recording may be useful in diagnosing akathisia masked by hypokinesia, but the typical subjective symptoms of akathisia should not be ignored, even when actometry is not available to demonstrate the missing motor component of akathisia. Not only akathisia defined by DSM-IV but also subjective akathisia should be adequately treated to relieve the subjective distress, and to diminish the unfavorable effects on psychotic symptoms, behavior, and drug compliance.

Adult↗
PubMed2004

Chronic antidopaminergic medication might affect amygdala structure in patients with schizophrenia.

BACKGROUND: Recently amygdala enlargement has been reported in patients with schizophrenia like psychosis of epilepsy. The effect of antipsychotic medication on amygdala structure has not been investigated so far. There is theoretical evidence to support the assumption that dopaminergic neurotransmission might affect neuronal plasticity. METHODS: In order to analyze the influence of chronic antidopaminergic medication on amygdala structure we compared amygdala volumes in patients with schizophrenia like psychosis of epilepsy (POE) treated with neuroleptic medication (n = 11) to patients with POE not treated with such medication (n = 15), patients with epilepsy alone (n = 24) and healthy control subjects (n = 20). RESULTS: Analyzing our data with a factorial ANOVA approach, we found a significant effect of the factor medication in that patients treated with antipsychotic medication displayed a "normalization" of the increased amygdala volumes observed in the untreated patient group. CONCLUSION: This observation supports the assumption that antidopaminergic medication might affect the amygdala structure.

Amygdala↗
PubMed1994

Zuclopenthixol decanoate in maintenance treatment of schizophrenic outpatients. Minimum effective dose and corresponding serum levels.

23 schizophrenic outpatients in maintenance treatment with zuclopenthixol decanoate were included in a study aimed at finding the minimum effective dose and corresponding serum concentration of zuclopenthixol. Every three months the dose was gradually reduced until prodromal symptoms appeared, indicative of an incipient relapse. A slightly higher dose was then promptly reinstituted (the minimum effective dose). At each dose level, two blood samples were drawn to determine the serum concentration. This dose reduction principles proved feasible. Only one patient had a clear-cut relapse. The condition of the remaining patients was acceptably maintained by a dose increase. The minimum effective dose of zuclopenthixol was 200 mg/2 weeks (range 60-400), with a serum concentration of 22 nmol/l (7.1-69.7). There was a significant correlation between the administered dose and the corresponding serum level of the drug (r = 0.66, P < 0.01). A trend towards a positive correlation was found between the serum level at the minimum effective dose and the BPRS score (r = 0.42, P < 0.1). No correlation was found between the serum level and the side-effects or length of neuroleptic treatment. It is concluded that routine serum drug monitoring is hardly indicated in the long-term depot-neuroleptic treatment of schizophrenic patients. A strategy aiming at continually seeking the lowest effective dose on the basis of clinical parameters appears more appropriate, especially in case of depot-neuroleptic treatment.

Adult↗
PubMed1989

Clinical and pharmacokinetic evaluation of zuclopenthixol acetate in Viscoleo.

The purpose of the present study was to evaluate zuclopenthixol acetate in Viscoleo, a new preparation to be administered once every 3 days, in the early treatment of acute psychotic episodes and acute deterioration of chronic psychosis. 21 cases were included in the study: patients received 1 to 3 injections. Clinical evaluation was made at 24, 48 and 72 hours after each injection, using the Clinical Global Impressions (CGI) and the Brief Psychiatric Rating Scale (BPRS). Results at end-point indicated a marked or moderate therapeutic effect in the 11 cases of acute psychosis. A statistically significant decrease was observed for the total BPRS score as well as for its subscales. Among 8 cases of exacerbation of chronic psychosis, 4 patients showed a moderate therapeutic effect, and minimal or no effect was found in the other 4 subjects. The total BPRS decreased significantly, but to a lesser extent than for acute psychosis. Two patients suffering from mania showed a moderate therapeutic effect according to CGI. 8 cases of acute psychosis and 5 cases of chronic psychosis did not suffer from any neurological side-effects. Plasma concentration measurements suggest that a dose of 50 mg per 3 days may be sufficient for early treatment of most acutely ill psychotic patients.

Adolescent↗
PubMed1987

Zuclopenthixol and perphenazine in patients with acute psychotic states. A double-blind multicentre study.

Fifty-four patients with acute psychotic states were included in a double-blind multicentre study of zuclopenthixol and perphenazine given orally. Fourteen patients had not received test preparations for a minimum of 3 weeks as stated in the protocol, and were excluded. The remaining 40 patients received the test preparations for 3 to 12 weeks, with an average of 49 days for patients receiving zuclopenthixol and 45 days for patients receiving perphenazine. Clinical evaluations were done at baseline and at weeks 1, 2, 4, 6, 8, and 12 including the CGI, a CPRS subscale for schizophrenia, and the UKU Side Effects Rating Scale. The patients received on average 37 mg zuclopenthixol or 30 mg perphenazine daily. Statistically, significant reductions on the CGI, severity of illness, and on the CPRS (total score) were found for both drugs when comparing baseline with later scores. No significant differences between the drugs were found. It was also impossible to demonstrate a difference in clinical profile between the two drugs on the basis of the single items on the CPRS. Although small differences between the two drugs were found, as regards number and type of side effects, it is concluded that the pattern of side effects was almost identical in the two treatment groups.

Clopenthixol↗
PubMed1994

[Drug-induced asterixis].

A 54-year-old woman with acute schizoaffective psychosis was treated with lithium carbonate (1,350 mg daily) and zuclopenthixol. On admission, clozapine was added (250 mg daily). Because extrapyramidal symptoms (rigor, akinesia) developed, she was additionally given biperiden retard (4 mg daily) from the fourth hospital day onwards. Eleven days after admission she began to complain of "unsteadiness" and "tremors" in her arms and she had asterixis (flapping tremor) on holding up her arms. The electromyogram showed electrical pauses of 60-120 ms, typical for asterixis. There were no significant metabolic or organic cerebral changes that could have accounted for the symptoms which presumably had been induced by the drugs even though their dosage was not unusual. The symptoms in fact regressed completely after the clozapine dose had been reduced, at first to 125 mg then to 50 mg. Previous experience has suggested that the risk of asterixis is particularly high when lithium and clozapine are taken together.

Biperiden↗
PubMed2002

Classical and atypical neuroleptics, and bone mineral density, in patients with schizophrenia.

There are some reports that classical neuroleptics may lead to osteoporosis or reduced bone mineral density (BMD). However, there is no adequate information about the effects of atypical neuroleptics on BMD. The aim of this study was to measure BMD in schizophrenic patients taking classical and atypical neuroleptics, compared to healthy controls. Seventy-five patients with schizophrenia (40 taking classical neuroleptics [CN], 35 taking atypical neuroleptics [AN]) and 20 healthy controls (HC) were included in the study. Spine (L1-L4) BMD was measured by dual-energy X-ray absorptiometry. ANOVA showed that BMD was higher in HC than AN and CN. In addition, there was a negative correlation between the duration of neuroleptic treatment and BMD and the duration of the illness. These findings suggest that atypical neuroleptics may be safer than the classical neuroleptics in terms of reduced BMD.

Adult↗
PubMed2001

Psychosis and pregnancy: five cases of severely ill women.

An increasing number of patients with chronic mental disease are now integrated in society. As a consequence, women with severe psychiatric illness may become pregnant and wish to complete the pregnancy and to give birth to a child. The lack of sensation of reality in these patients and their social situation may result in particular problems in their treatment, and it may be necessary to admit them to a psychiatric ward before delivery. In this paper five cases of pregnant women with severe and chronic psychosis are described. These patients had many problems in common. Thus, they were all schizophrenics with very severe psychopathology, had poor understanding of their own situation, and lacked social networks. All the fathers were non-Danish. Coercion was used in all cases. To help women with severe mental illness to go through pregnancy and childbirth requires close collaboration between psychiatric and obstetric staff and social workers, and this should be organized in an institution with experience in the treatment of this type of patient.

Adult↗
PubMed2006

Antipsychotic medication and length of stay at a psychiatric maximum-security unit in Norway (1987-2000).

The aim of this study was to evaluate psychopharmacological treatment and the length of stay (LOS) of patients with schizophrenia in a maximum-security psychiatric unit. Data were collected from the hospital files of 82 consecutively admitted patients with schizophrenia who were both admitted and discharged between the years 1987 and 2000. Psychotropic medication and LOS at the time of discharge were registered. Ninety-five per cent of the patients received antipsychotic medication. Zuclopenthixol was the most frequent medication, given to 43% of the patients. Antipsychotic polypharmacy was found in 20% of the cases. Twenty-seven per cent of the patients were medicated with doses above the recommended therapeutic dose range. During the study period, there was no change in the administration and number of psychotropics, but there was an increase in the dosage of antipsychotics. However, LOS was unchanged during the same time. This supports other findings, which suggest that there is no clinical benefit of higher antipsychotic dosage. It is suggested that an optimized medication practice could yield beneficiary effects, not only for schizophrenic symptoms, but also for violence in schizophrenic patients.

Adult↗
PubMed1999

Long-acting antipsychotic medication, restraint and treatment in the management of acute psychosis.

OBJECTIVE: Zuclopenthixol acetate (ZA) is the first parenteral antipsychotic medication introduced for clinical use in the treatment of aggression and agitation that has a relatively prolonged duration of action. The aim of this paper is to explore a number of important ethical and clinical issues that are raised by the use of this novel therapeutic formulation. METHOD: Relevant literature is explored and several issues are identified from which arguments for and against the use of medication of this type are raised. These issues are considered in general and with the use of a number of stylised clinical scenarios. RESULT: The use of long-acting antipsychotic medication is complicated by its impact upon patient autonomy, by considerations of informed consent and by the need to provide justice to all patients and staff in a psychiatric treatment setting. The use of ZA in the emergency treatment of psychotic patients may only be justified under specific clinical circumstances and its use is not appropriate as routine chemical restraint. CONCLUSIONS: Zuclopenthixol acetate is a novel and potentially useful treatment alternative in the acutely disturbed patient. Institutions in which ZA is used in emergency settings should develop protocols to guide clinicians in its appropriate use and provide monitoring.

Acute Disease↗
PubMed2001

Zuclopenthixol treatment of behavioral disturbances in mentally retarded children and adolescents: an open-label study.

The present open-label study assessed the efficacy of zuclopenthixol, an thioxanthene neuroleptic with combined dopamine receptors (D1/D2) antagonist activity, in the treatment of severe behavioral disturbances in mentally retarded children and adolescents. A sample of 15 (11 males, 4 females) mentally retarded children and adolescents, ages 5-18 years (12.2 +/- 2.3 [mean +/- SD] years), all exhibiting severe behavioral disturbances, was evaluated. The 12-week zuclopenthixol treatment (up to 26 mg/day) was initiated after a week's washout from previous antipsychotic agents. An assessment of the behavioral disturbances was performed using the 14-item Checklist for Behavior Problems Involving Limited or No Social Awareness (CBP-NSA). The Udvalg for kliniske undersøgelser (UKU) Side Effect Rating Scale was used to assess the pharmacologic side effects. Results show a significant reduction in total CBP-NSA scores and in individual items such as hyperactivity, aggressive behavior, and temper tantrums (p < 0.001 for each). It seems that zuclopenthixol monotherapy is effective and well tolerated in the treatment of severe behavioral disturbances in mentally retarded children and adolescents. Double-blind, placebo-controlled studies are needed before definitive conclusions can be drawn regarding the efficacy and safety of zuclopenthixol for this population.

Adolescent↗