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PubMed1975

Peroral and parenteral administration of long-acting neuroleptics: a double-blind study of penfluridol compared to flupenthixol decanoate in the treatment of schizophrenia.

Fifty-six out of 60 schizophrenic patients completed a double-blind study of two long-acting neuroleptics, penfluridol (peroral) and flupenthixol decanoate (parenteral). Half of the patients were on maintenance therapy of flupenthixol prior to the study, the other half on penfluridol. The actual double-blind study (12 weeks) was commenced after a preliminary period of 4 weeks, the patients in the two main groups being randomly divided into two further groups, one continuing the medication unchanged, the other changing to the alternative drug. It was found possible to make a sudden switch from penfluridol to flupenthixol decanoate and vice versa without any significant change in the condition of the patient. The same dosage (in 70% of the patients from 40 to 80 mg) of penfluridol was used per week as was employed for flupenthixol decanoate per fortnight. Changes in the intensity of the symptoms (total Brief Psychiatric Rating Scale (BPRS) score) were moe pronounced in the preliminary period (during unchanged treatment) than on changed medication in the blind period. Both drugs induced approximately the same degree of akathisia, Parkinsonism and autonomic side effects. The practical consequences of equipotent therapeutical effect of a peroral and parenteral long-acting neuroleptic are briefly discussed.

Administration, Oral↗
PubMed1980

Intramuscular haloperidol decanoate for neuroleptic maintenance therapy. Efficacy, dosage schedule and plasma levels. An open multicenter study.

Thirty-eight hospitalized chronic psychotic patients were injected (i.m.) every 4 weeks with haloperidol decanoate using different dosage schedules which were calculated from the previously prescribed daily oral dose of haloperidol multiplied by a factor of 30, 20 or 10. The 20-fold schedule appeared to be adequate in most of the patients. All patients were well stabilized on their optimal dose schedule and several symptoms improved even further during treatment. No increase of extrapyramidal or other side-effects was reported in any of the patients. Antiparkinson medication could be omitted in 37 patients without problems. There was neither pain nor irritation at the site of injection. Plasma levels of haloperidol reaching a steady state after the second injection of haloperidol decanoate were about two times higher than during the previous oral treatment with haloperidol. No accumulation was observed. Haloperidol decanoate injected every 4 weeks proved to be as safe and therapeutically reliable as orally administered haloperidol.

Adult↗
PubMed1980

Clopenthixol decanoate and perphenazine enanthate in schizophrenic patients. A double-blind Nordic multicentre trial.

The clinical properties of clopenthixol decanoate has been investigated versus perphenazine enanthate in a double-blind clinical multicentre trial including 14 psychiatric hospitals in Finland, Sweden, Norway, and Denmark. Test treatment was initiated in 172 chronic schizophrenic patients and the planned 6 months test period was completed by 57 patients receiving clopenthixol decanoate and 48 receiving perphenazine enanthate. The therapeutic effect was assessed by means of CGI, BPRS, and NOSIE-30 and was found significant with both test drugs. Significant differences in the effect were seen only in "Hostile-suspiciousness" (BPRS) and "Social interest" (NOSIE-30). For these items clopenthixol decanoate was found superior to perphenazine enanthate. The influence of side effects on the patients' functioning was found to be slightly, but not significantly more troublesome in the perphenazine enanthate patients.

Adult↗
PubMed1980

A specific method for assay of drug levels in serum of patients treated with clopenthixol decanoate injections.

A fluorimetric method is presented for the simultaneous and specific assay in serum of clopenthixol decanoate, clopenthixol and a clopenthixol metabolite, deprived of the ethanol group in the side chain. The separation is achieved by extractions and thin layer chromatography and fluorescence brought about by treatment with sulphuric acid. The limit of detection in 3 ml serum samples is about 2 ng/ml for clopenthixol and mtabolite, and somewhat higher for the ester. In addition serum data are presented for patients treated with intramuscular injections of 100-600 mg clopenthixol decanoate in Viscoleo every second week. Relatively stable (mean max./min. ratio about 2; maximum after 3-7 days) clopenthixol levels were recorded through-out the dosage interval. Somewhat lower metabolite levels were found. There was no evidence for the presence of clopenthixol decanoate.

Clopenthixol↗
PubMed1983

Depression-inducing and antidepressive effects of neuroleptics. Experiences with flupenthixol and flupenthixol decanoate.

The antidepressive and anxiolytic efficacy of flupenthixol has been investigated in numerous controlled and open trials involving patients with endogenous, reactive as well as senile depressions. When administered at a mean daily single or multiple dose of 1-2 mg, flupenthixol proved to be a very effective and well-tolerated antidepressant. As opposed to some of the currently available antidepressants, flupenthixol has a rapid onset of action which is often displayed within the first 2-3 days following its application. Flupenthixol decanoate has also a pronounced antidepressive and anxiolytic effect which appears to be adequate enough for treating mild to moderately severe syndromes of depression. This depot neuroleptic has been given at a fortnightly dosage ranging between 2.5 and 30 mg. However, if the aspect of efficacy in relation to tolerance has to be taken in to consideration, then 5 mg are apt to be an appropriate dose. Patients with an agitated depression and/or suicide ideation should, however, be excluded from therapy with this drug. Extrapyramidal movement disorders which may appear during treatment are a disadvantage of this medication. Apparently such disorders are rarely encountered if the dose is kept below 10 mg. Other untoward effects are very seldom indeed. A final and conclusive judgement on the possible application of flupenthixol decanoate in the prophylaxis of phases in patients with bipolar and periodical depressions is as yet not feasible. Further clinical trials are necessary before flupenthixol decanoate can be classified as a possible 'depot antidepressant'.

Anxiety Disorders↗
PubMed1982

Catalepsy produced by long-acting neuroleptics, fluphenazine enanthate and fluphenazine decanoate, in mice.

The cataleptic state induced by the depot-type preparations of fluphenazine (FZ) was investigated in mice. Intramuscular injections of FZ-enanthate or FZ-decanoate produced a marked and long-lasting catalepsy, which was antagonized by trihexyphenidyl, biperiden and promethazine but not by l-dopa. These anticataleptic effects disappeared after several hours and catalepsy occurred again. The cataleptic effects of FZ-enanthate and FZ-decanoate were increased by (D-Ala2, MePhe4, Met(0)5-ol)-enkephalin, aminooxyacetic acid and haloperidol. The results indicate that the cataleptic effects of FZ-enanthate and FZ-decanoate correspond with their long duration of antipsychotic effects and that the catalepsy may involve enkephalinergic, GABAergic and cholinergic as well as dopaminergic neuron activity.

Aminooxyacetic Acid↗
PubMed1982

Pharmacokinetics of haloperidol decanoate. A 2-year follow-up.

Plasma haloperidol levels were assayed in 181 chronic schizophrenic inpatients, who were monthly injected intramuscularly with haloperidol decanoate. Steady state levels are reached after the third monthly injection and then remain constant, being associated with a remarkably stable control of the psychotic condition. Between two subsequent injections the haloperidol levels decrease gradually by about half their initial value. The haloperidol plasma levels strongly correlate with the injected doses of the decanoate form. For a single dose of 100 mg haloperidol decanoate monthly the minimal steady state value is about 4 ng/ml.

Chronic Disease↗
PubMed1982

12-month study of haloperidol decanoate in chronic schizophrenic patients.

239 psychotic patients entered a 52-week open study comparing the efficacy and safety of intramuscular haloperidol decanoate, injected once every 4 weeks, with that of their previous maintenance therapy. Haloperidol decanoate, given at a medium monthly dose of 100 mg provided a suitable substitute for oral neuroleptic mono- and polytherapy and intramuscular fluphenazine decanoate. Stabilization or slight improvement was observed for all ten symptoms selected from the BPRS. The drug provoked a low incidence of side-effects allowing reduction of antiparkinsonian medication and there were no significant haematological or biochemical changes.

Adult↗
PubMed1981

Fluphenazine decanoate and tardive dyskinesia: a possible association.

The authors examined the charts of 22 outpatients who had received intramuscular fluphenazine decanoate and oral fluphenazine hydrochloride to assess the incidence of tardive dyskinesia. The severity of tardive dyskinesia was assessed with the Abnormal Involuntary Movement Scale (AIMS). Both the total dose and average daily dose of fluphenazine decanoate correlated significantly with high AIMS scores. There were also significant correlations of AIMS scores with total dose of antiparkinsonian medication and total dose of other neuroleptics. Total dose of antiparkinsonian medication correlated with total dose of fluphenazine decanoate. The authors discuss the clinical and physiological implications of these correlations.

Adult↗
PubMed1989

Fluphenazine decanoate: a clinical problem?

The authors compared the medical records of 20 randomly selected schizophrenic patients who were receiving fluphenazine decanoate with the records of 20 other randomly selected schizophrenic patients who were receiving oral medications only. The fluphenazine decanoate group had a significantly higher mean chlorpromazine equivalent dose (2010 +/- 836) than the oral medication group (373 +/- 384). The two groups did not, however, differ on any of the other variables studied. The findings, in addition to reports in the literature, suggest that the use of fluphenazine decanoate may come at the inadvertent cost of a significantly higher dose of antipsychotic medications in a subgroup of patients.

Antipsychotic Agents↗
PubMed1995

D2 dopamine receptor occupancy during low-dose treatment with haloperidol decanoate.

OBJECTIVE: The aim of this study was to examine the relationships among clinical effects, central D2 dopamine receptor occupancy, and plasma concentrations of haloperidol in eight clinically stabilized schizophrenic outpatients who were responding to treatment with low doses of haloperidol decanoate. METHOD: During a 4-week interval of haloperidol decanoate dosage (dose range = 30-50 mg), the patients' D2 receptor occupancy was determined with positron emission tomography on two occasions. Plasma concentrations of haloperidol were determined with a sensitive high-performance liquid chromatography method. RESULTS: One week after injection of haloperidol decanoate, the mean D2 receptor occupancy was 73% (range = 60%-82%), and the mean plasma concentration of haloperidol was 4.6 nmol/liter (range = 2.9-9.7). After 4 weeks, the mean D2 receptor occupancy had decreased to 52% (range = 20%-74%), and the mean haloperidol concentration to 2.3 nmol/liter (range = 1.0-4.4). CONCLUSIONS: The D2 receptor occupancy 1 week after injection was high and comparable to that previously found in patients responding to acute treatment with classic neuroleptics. Prevention of relapse was maintained despite low D2 receptor occupancy during the latter part of the treatment interval. These observations indicate that continuously high D2 receptor occupancy may not be necessary to prevent schizophrenic relapses. The results emphasize the need for systematic clinical evaluation of intermittent low-dose treatment strategies.

Adult↗
PubMed1999

Comparative effectiveness of fluphenazine decanoate injections every 2 weeks versus every 6 weeks.

OBJECTIVE: Dose reduction strategies for the maintenance treatment of schizophrenia are designed to maintain the benefits of antipsychotic drug therapy while reducing risks. Previous strategies with decanoate preparations have been based on the use of lower doses per injection to achieve dose reduction; these strategies have achieved dose reduction but have resulted in some increase in symptoms. The authors tested a new dose reduction approach: increasing the interval between injections during intramuscular decanoate antipsychotic treatment. METHOD: Fifty outpatients with schizophrenia or schizoaffective disorder were randomly assigned to receive 25 mg of fluphenazine decanoate intramuscularly either every 2 weeks or every 6 weeks for 54 weeks in a double-blind design. RESULTS: The two dose regimens did not differ significantly in relapse, symptom, or side effect measures. The every-6-weeks regimen was associated with a significant reduction in total antipsychotic exposure. CONCLUSIONS: The use of injections every 6 weeks instead of every 2 weeks may increase compliance and improve patients' comfort as well as decrease cumulative antipsychotic exposure, without increasing relapse rates or symptoms.

Adult↗
PubMed2002

A multidose study of haloperidol decanoate in the maintenance treatment of schizophrenia.

OBJECTIVE: Maintenance medication is critical in the prevention of psychotic relapse and rehospitalization among patients with schizophrenia. Given potential adverse effects, identification of the minimum effective dose is clinically important. METHOD: A multicenter, double-blind study was conducted to determine rates of symptomatic exacerbation and adverse effects in 105 outpatients with schizophrenia randomly assigned to four different fixed doses of haloperidol decanoate and treated for 1 year or until relapse. The doses used were 25, 50, 100, and 200 mg given intramuscularly once per month. RESULTS: Rates of symptomatic exacerbation were 15% in the 200-mg group, 23% with 100 mg, 25% with 50 mg, and 60% with 25 mg. No significant differences in outcome were found between the groups treated with 200, 100, and 50 mg. Among the patients who completed the trial with no symptomatic exacerbation, there were no differences between dose groups on measures of psychopathology at the final rating point. CONCLUSIONS: The results of this study suggest that the 200-mg/month dose of haloperidol decanoate is associated with the lowest rate of symptomatic exacerbation (15%) with minimal increased risk of adverse effects or subjective discomfort in comparison to 100 or 50 mg. At the same time, the rates of worsening with 100 mg (23%) and 50 mg (25%) were not significantly greater than that seen with 200 mg. These results provide some guidance as to effective dose ranges of haloperidol decanoate.

Adult↗
PubMedDate not supplied

[Evaluation of effectiveness and tolerance of the long-term treatment with bromoperidol decanoate in psychotic disorders].

An open study in 20 patients (7 M, 13 F, mean age 40 years) has been performed in order to evaluate the effectiveness and the safety of bromperidol decanoate in the long-term treatment of psychotic disorders. Patients were selected according to DSM-III-R diagnostic criteria (schizophrenia, residual type: 6 patients; disorganized type: 4; paranoid type: 5; undifferentiated type: 2; atypical psychosis: 3) and treated with bromperidol decanoate 150 mg i.m. (single administration) every month for 6 months. The BPRS scores significantly decreased at the end of the therapy with respect to the beginning (-39.5%; p less than 0.01 Friedman analysis between times); this improvement was already significant at the first month control. The results obtained from a clinical global impression, evaluated from the Visual Analogical Scale (VAS), showed that all patients improved at the end of the therapy (p less than 0.01 ANOVA between times). The side effects, mainly extrapyramidal ones, were mild and did not interfere with the therapy; in fact none patient dropped-out from the treatment. Bromperidol decanoate showed to have a good efficacy and safety in the therapy of psychotic disorders, with a stabilizing effect on the depressive mood.

Adult↗
PubMed2001

Interaction between nandrolone decanoate and calcitonin in bone formation markers (osteocalcin and bone specific alkaline phosphatase) and IGF-I in rats.

Bone tissue has been shown to contain numerous cell-to-cell signaling peptides called growth factors. These growth factors are thought to have important regulating effects for bone remodeling, due to their potent effects on bone cell metabolism. Our investigation was intended to assess the effect of nandrolone decanoate and calcitonin treatment on biochemical markers of bone formation (bone alkaline phosphatase - osteocalcin) and insulin-like growth factor-I in rats. We studied 48 adult male rats. The animals were divided into four groups. Group (A) served as control. Animals in Group (B) were injected with 4 mg/kg/day nandrolone decanoate. Animals in Group (C) were injected with 400mU/rat/day calcitonin and Group (D) received combined therapy for seven days. Nandrolone decanoate and calcitonin have a mild but significant effect on insulin-like growth factor-I without affecting osteocalcin levels, while calcitonin alone decreases the BALP levels. The coadministration of two agents caused notable elevation on insulin-like growth factor-I, followed by a significant increase of osteocalcin and bone alkaline phosphatase.

Journal Article↗
PubMed1986

An open clinical trial with the long-acting neuroleptic zuclopenthixol decanoate in the maintenance treatment of schizophrenia.

Nineteen chronic schizophrenics were included in an open trial to evaluate the depot neuroleptic, zuclopenthixol decanoate. The treatment period was 24 weeks and clinical evaluations were carried out every 4 weeks including the CGI, the BPRS (completed at Weeks 0, 4, 8, 16, and 24), the Hamilton Depression Scale (completed at Weeks 0, 12, and 24), and a side-effects check list. Patients received 200 mg zuclopenthixol decanoate intramuscularly at intervals dependent on the severity of the illness. Statistically significant reductions were found for most of the symptoms on the BPRS. The reduction was already seen after 4 weeks of treatment. A clear improvement was also recorded on the Hamilton Depression Scale. The frequency of side-effects was low and decreased during the treatment period. The side-effects recorded were mild and, according to the CGI, they did not interfere with the patients' functioning except in 1 case (Week 24). It is concluded that zuclopenthixol decanoate is an effective and well-tolerated drug in the maintenance treatment of chronic schizophrenia.

Adult↗
PubMed1984

[A new injectable delayed-action neuroleptic with sedative and antipsychotic action: cis-(Z)-clopenthixol decanoate. Clinical trials].

70 psychiatric patients were treated with a depot preparation of cis (Z) clopenthixol decanoate, a new sedative and anti-psychotic neuroleptic. The mean dosage interval was two weeks, an amount of drug from 50 to 1000 mg for each I.M. injection. Significant improvements were obtained on thinking disturbance, hostile-suspiciousness and anxious-depression symptoms groups. Thus, paranoid schizophrenia seems the best indication of cis (Z) clopenthixol decanoate. Side effects (parkinsonism, weight increase) were of low intensity, and no depression was observed. This new long-acting depot neuroleptic may be used not only in hospitalized chronic schizophrenic patients, but also in outpatients as maintenance treatment: excellent results were obtained in such patients with a very low (less than 200 mg) fortnightly dosage. Advantages and indications of cis (Z) clopenthixol decanoate are discussed.

Adult↗
PubMed1981

The effects of nandrolone, testosterone and their decanoate esters on murine lupus.

Treatment of NZB/NZW F1 (B/W) female and castrated male mice with testosterone or 19-nortestosterone (nandrolone), either by implantation in silastic tubing or by subcutaneous injections of their decanoate esters, reduced in a dose-dependent manner symptoms associated with murine lupus (proteinuria, IgG antibodies to DNA) and prolonged survival. These phenomena were observed under both prophylactic (start at 3-4 weeks) and therapeutic treatments (start 27-29 weeks). Nandrolone and its decanoate ester were at least as potent as testosterone and testosterone decanoate. As the unwanted androgenic properties of nandrolone and its ester are significantly less pronounced than those of testosterone and its ester, also in these NZB/NZW mice, the beneficial effect on murine lupus does not seem to be associated with these properties.

Animals↗