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To provide long-term sedation, a horse was given fluphenazine decanoate, a human antipsychotic drug. The horse was progressively agitated and made unusual repetitive motions. Sedation with barbiturates was an effective treatment. This case is not unusual, and the use of fluphenazine by veterinarians in horses as a mild long-acting tranquilizer is not uncommon.
The purpose of our experience was to determine the efficacy of haloperidol decanoate during the treatment of chronic psychotic in-patients. So we included, in an open study, 30 patients hospitalized in the Esquirol and Magnan Departments of the National Hospital of Mental Health "Dr. Braulio A. Moyano". As a result of this study, we have observed that to the already known properties of this drug, it may be added, because of its new depot formulation, the following advantages: a) it replaces effectively the daily intake of neuroleptics; b) it allows the reduction of the dose of oral neuroleptics as well as the number of drugs combination; c) it diminishes the incidence of extrapyramidal symptoms, allowing the reduction of the dose or the interruption of antiparkinsonian drugs; d) it facilitates the nurse's labor; e) it allows the physician to be sure of the fulfillment of his prescription.
Concern about the dose of neuroleptic drugs has become widespread in recent years. This concern largely has been prompted by recognition of the apparent relationship between neuroleptic dose and potential adverse effects, such as tardive dyskinesia and extrapyramidal symptoms. Therefore, it is critical to establish dosing strategies for long-term therapy that emphasize a minimal effective dose. Such a dosing strategy for long-acting injectable neuroleptics, including haloperidol decanoate, is highlighted. A low initial dose of the long-acting drug is recommended, with gradual dosage adjustment over an extended period of time. General guidelines for using oral supplementation are also provided.
A long-term open clinical study was made on nine schizophrenic patients, using injectable bromperidol decanoate in monthly doses. The dosage calculation was made from the haloperidol doses previously received by the patients, adjusted in each particular case, with a mean of 73 mg per application (range, 50 to 200 mg). The patients were seven males and two females with a mean age of 37,7 years, 11,8 years of evolution of the disease and 2,6 previous hospitalizations. The symptoms evaluation was based on the BPRS test, converting the impressions of professionals and patients on the ten symptoms into an arbitrary scale from 0 to 5 for their later statistical evaluation using the least-squares test. All the psychotic symptoms improved gradually and significantly due to the medication. The harmlessness of bromperidol was evaluated through complete blood and urine tests, which, repeated every month, showed no blood, liver, renal, etc. alterations due to the drug. Like all psychopharmacos derived from butyrophenone, bromperidol can cause collateral effects of an extrapyramidal type. These appeared in four of the nine patients, being tremors, sialorrhea and akathysia the most important ones. These were the only collateral effects. Two of the patients were also receiving phenothiazine and the four patients were well controlled by using trihexiphenidyl.
A study was performed to establish the efficacy of haloperidol decanoate used as a drug to replace other neuroleptics, previously applied orally and daily to hospitalized chronic psychotic patients, clinically stabilized. For this study, 30 patients received one injection of this preparation every 4 weeks, during 4 months. After reviewing the results, it is concluded that this drug is very useful in these patients.
In order to evaluate the efficacy and tolerance to Haloperidol Decanoate, 26 patients with different psychotic disorders were included in a six month's clinical study. The dose administered monthly was equivalent to twenty times the oral daily doses of neuroleptics generally used by these patients. In 92% of the cases an improvement higher than a 70% of the clinical symptoms was achieved, if comparing the baseline with final data. In no patient results inferior to those observed with oral neuroleptics were detected. Adverse reactions like parkinsonism or dyskinesia were present in some patients. However their intensity was mild to moderate, over a short period of time only.
Plasma levels of imipramine and desipramine were monitored in a series of 13 patients with postpsychotic depressions who had a fixed dose of imipramine (150 mg/day) added to their clinically adjusted, stable dose of fluphenazine decanoate. Despite the potential for metabolic inhibition of the tricyclic drug by the neuroleptic drug, no relationship was found between the fluphenazine dose and the subsequent plasma concentrations of imipramine and desipramine. However, plasma antidepressant levels after 1 week at a low dose (50 mg/day) identified patients who later generated high plasma antidepressant levels at the full antidepressant dosage. The clinical implications of these observations are discussed.
24 patients have been treated with cis(z)-flupenthixol decanoate for 6-12 months. Intramuscular injections were given about every 3 weeks. Before treatment and on each day of injection the mental state was assessed by BPRS and registration of side effects was performed. Blood samples were taken 7 days after each injection and on the last day of the dosage interval. Neuroleptic activity was determined in serum by RRA and expressed in cis(z)-flupenthixol equivalents. The drug level was significantly correlated to the dose. No clear relationship between drug level and clinical results as well as side effects was found. Less pronounced variations of the drug level between subsequent injections resulted in a positive therapeutic response.
A group of 13 untreated schizophrenic patients was collected over two and a half years. They were prescribed a standard regime of oral haloperidol, and where possible were transferred to haloperidol decanoate depot injections when their clinical condition stabilised. The progress of their symptoms was monitored weekly with a modification of the Present State Examination called the PSE Change Rating Scale. The ratings demonstrated a surprisingly good response to neuroleptic treatment in these chronic patients. Ten out of the 13 reached an arbitrary criterion of improvement with respect to psychotic symptoms, and in six patients these disappeared entirely. The reasons why the patients remained untreated for so long are considered, and include vagrancy, living with high Expressed Emotion relatives, and neglect in the community.
Seventy-three chronic schizophrenic outpatients were studied for 1 year to determine if neuroleptic drug levels could be useful in preventing relapse. All patients received fluphenazine decanoate i.m., and serum level of neuroleptic was determined by radioreceptorassay. Clinical improvement was measured using the Global Assessment Scale. Results indicate that serum neuroleptic drug levels may be useful in the outpatient management of chronic schizophrenics.
In an open, prospective 12 month study of perphenazine decanoate (PD), 42 psychotic patients diagnosed according to DSM-III were treated with a fixed depot interval and an individual dose, guided by gas chromatographic perphenazine plasma concentration monitoring combined with clinical evaluation. Degree of illness was rated using a social-psychiatric CGI-scale and extrapyramidal side effects were evaluated by means of a modified Simpson and Angus rating scale. After six months of treatment, a statistically significant improvement was found (p less than 0.001). During the last six months a further slight reduction in mean CGI-scores was observed. Mild to moderate extrapyramidal side effects occurred in 9 patients (21%) principally during the initial phase of therapy. No other side effects or changes in blood chemistry were found during the study. Plasma concentrations of perphenazine increased during the initial 3 months and stabilized hereafter. There were however, large intra- and inter-individual variations in the perphenazine plasma concentration/dose ratio. In addition, it was observed that plasma concentrations of perphenazine were significantly higher in patients who had been treated with neuroleptics for more than 10 years compared to those who had been treated 5 years or less. This observation indicates gradual development of tolerance to neuroleptic treatment. This study demonstrates that PD is a safe and effective remedy for maintenance therapy in psychotic patients.
In order to investigate the feasibility of administering perphenazine decanoate (PD) at three week intervals the 42 patients participating in the previously reported open, prospective 12 month study were, after six months, treated according to the following scheme: 21 patients continued to receive injections every two weeks (group I), whereas in the remaining 21 patients the intervals between injections were extended to 3 weeks (group II). Both groups continued to respond equally well to therapy. Moreover it was observed that the mean daily dose of perphenazine was significantly reduced when using 3 weeks intervals. This study demonstrates that PD administered every 3 weeks is a safe and effective remedy for maintenance therapy in psychotic patients.
Penfluridol, a diphenylbutylpiperidene derivative, is a new long acting neuroleptic, administered orally, once weekly. It is marketed in several European countries and has been used successfully in the treatment of various acute psychoses, for severely ill chronic schizophrenic patients, and as maintenance therapy for chronic schizophrenic patients. The present study was designed to compare, in a double-blind fashion, the efficacy of penfluridol and fluphenazine decanoate in the maintenance therapy of schizophrenic outpatients.
The role of the "heat stroke" is discussed on account of an observation of hyperthermia (42 degrees C or 107.6 Farenheit) that occured with a patient under fluphenazine decanoate, during the summer 1976 heat wave. Contrary to the American descriptions of heat strokes, the patient kept his perspiring ability. Moreover, there was no hypertonic extrapyramidal syndrome, but hypotonia instead. It is to be noted that the preliminary treatment by the corresponding standard neuroleptic (fluphenazine chlorhydrate) did not prevent that hyperthermia whose evolution was rapidly favorable.
Haloperidol decanoate injected every 4 weeks is a very important basic therapy for the treatment of chronic psychiatric patients. The results of this investigation compared to a long-term treatment with neuroleptic polytherapy showed a superior action of HDD monotherapy in chronic schizophrenia. The dosage schema can be adapted individually whenever necessary. Antiparkinson medication could be reduced and sometimes omitted.
A study was carried out in 68 chronic schizophrenic out-patients to assess the therapeutic effectiveness and tolerance of long-term maintenance treatment with a depot preparation of clopenthixol decanoate. Patients received 200 mg to 600 mg doses by intramuscular injection every 2 to 3 weeks for a mean treatment period of 20.3 months. Clinical symptomatology was assessed at regular intervals using the Brief Psychiatric Rating Scale (BPRS) and any adverse effects were recorded against a standard check-list. The results showed that there was a significant reduction in total and factor composition BPRS scores after treatment in all patients, the improvement becoming generally evident by the sixth month of treatment. Few autonomic and neurological side-effects were reported.
The recently synthesized depot neuroleptic haloperidol decanoate (HD) has been mainly used in the treatment of chronic schizophrenia. In this trial 23 outpatients, 11 male and 12 female, suffering from schizophreniform disorders, according to the DSM III, were treated with 50 mg to 250 mg of HD, every 4 weeks for 12 months. At the end of the trial, the mean dosage of HD administered and BPRS (Brief Psychiatric Rating Scale) mean scores were significantly lower than the initial ones (70.8 mg VS 108 mg, and 21.5 VS 45.7 respectively). In 10 male patients, plasma levels of haloperidol and PRL were evaluated during the first four weeks of treatment. A positive correlation between haloperidol levels and clinical improvement and a significant increase in PRL levels in correspondence with haloperidol plasma peaks, but not with clinical improvement, were observed. These data indicate a dissociation between the effect of haloperidol after HD injection on the limbic dopaminergic system and the effect at the level of the tubero-infundibular system.
In a double-blind placebo substitution study, 27 chronic schizophrenic patients successfully treated for more than 2 years with fluphenazine decanoate were withdrawn from the drug. These patients showed a significantly higher relapse rate than the matched control group of 26 patients who continued to receive fluphenazine (56% versus 19%, p less than .001). This high rate of relapse is viewed as indicating the need for continued medication in most chronic schizophrenic patients.