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Twenty-nine patients were treated with haloperidol decanoate, the dosage ranging from 100 to 300 mg i.m. once a month, with duration of treatment ranging from 3-7 months. It seems that haloperidol decanoate could be useful in schizo-affective disorder/depressed type and also in manic disorder. The investigators were impressed by the relative lack of side effects.
Ten schizophrenic inpatients were each treated with perphenazine enanthate (PE) and perphenazine decanoate (PD). Following a cross-over study design it was possible to evaluate differences in plasma profiles between the two preparations, and to relate these to encountered side effects. All patients had previously been receiving neuroleptic treatment and had been diagnosed according to DSM-III. The dosage and intervals between injections were on an individual basis. The results indicate that at all dosage levels, the decanoate preparation showed significantly lower peak plasma concentrations of perphenazine. Extrapyramidal side effects and sedation were also less pronounced after the administration of PD. The more even and flat plasma concentrations obtained with PD, may facilitate plasma monitored therapy by using minimum concentration values.
In a 2- to 3-year open study 30 patients were treated with flupenthixol decanoate (depot form). These periodic and cyclic depressive patients had side effects during treatment with lithium salts. In comparison with the depressive and manic phases before the treatment, the prophylactic effect of flupenthixol decanoate on periodic and cyclic forms of depression was similar to the effect of lithium salts.
Patients receiving fluphenazine decanoate who were switched from adjunctive benztropine to imipramine in a double-blind trial experienced marked exacerbations of extrapyramidal side effects. No substantial increase in anticholinergic side effects occurred, however, when imipramine was added to fluphenazine decanoate and benztropine.
OBJECTIVE: This study evaluated the feasibility and impact of gradually reducing relatively high doses of fluphenazine decanoate by one-half for chronically impaired, poor inner-city patients with schizophrenia. METHOD: Forty-three patients currently receiving an average of 23 mg (0.3 mg/kg) of fluphenazine decanoate every 2 weeks were divided alternately into a group to remain at current doses (control group) and a group to undergo stepwise 50% dose reduction over 5 months under double-blind conditions. Clinical status and side effects were assessed quarterly for a year. Relapse was determined clinically and by changes in psychopathology ratings. RESULTS: Eighty-six percent (N = 37) of the patients (control group, N = 17; reduced-dose group, N = 20) completed the study. The groups did not differ at baseline in demographic or clinical variables or neuroleptic dose. In the reduced-dose group, doses were lowered to an average of 11.5 mg every 2 weeks. The two groups did not differ throughout the year in number of relapses, and hospitalization rates fell similarly in both (overall, by about 67%). Clinical measures changed little. Extrapyramidal symptoms worsened in the control group but improved slightly in the reduced-dose group. Tardive dyskinesia worsened in both groups, but less in the reduced-dose group. CONCLUSIONS: Maintenance neuroleptic doses much lower than the conventional ones can be achieved safely in schizophrenic patients by gradual reduction, without clinical worsening and perhaps with fewer extrapyramidal symptoms and less tardive dyskinesia. The two-thirds lower hospitalization rate, with substantial financial savings, apparently was due to nonspecific effects of research intervention.
A trial involving patients receiving fluphenazine decanoate was designed to compare the effects of orphenadrine hydrochloride (Disipal) and its major metabolite, tofenacin hydrochloride (Elamol) on the Parkinsonian side-effects and depression occurring during fluphenazine decanoate therapy. The trial was a double-blind one, with crossover. It was found that both drugs exerted an adequate control on the Parkinsonian side-effects, but there was no significant difference between their effects. Ophenadrine, however, was shown to be significantly superior (p less than 0-05) in the control of the depressive side-effects.
Sixty-eight depressed out-patients were allocated to treatment with either oral amitriptyline (75-225 mg/day) or intramuscular flupenthixol decanoate (10-30 mg every 14 days) in flexible dosage for 12 weeks under double-blind procedures. Various observer- and self-rating scales were applied before and after 2, 4, 8 and 12 weeks of treatment. Twenty-four patients completed the course of amitriptyline and 20 the course of flupenthixol. All variables improved over time, but there were no significant differences between the two drugs. The Newcastle scores pre-treatment were not related to drug response suggesting that both drugs were similarly effective across a wide spectrum of depressive disorders. Patients on amitriptyline tended to complain of dry mouth; those on flupenthixol had a higher incidence of extrapyramidal signs, the majority receiving anti-parkinsonian drugs at some time during the treatment. Flupenthixol decanoate in low dose is a useful anti-depressant, but should be restricted to short courses of treatment, to patients refractory to other treatments, and to patients suspected of poor compliance.
It can be said that a single hormone therapy with testosterone decanoate, drostanolone, and testosterone gave similar rates of objective responses in metastatic breast cancer. The presented randomized study has been done to prove whether an additional chemotherapy to hormone applications would further improve therapeutic results. During an observation period of 10 to 16 weeks testosterone decanoate and testolactone in combination with cyclophosphamide have more benefitial effects on the patients than drostanolone plus cyclophosphamide. The combination therapy augmented the rate of objective responses from 22-25 percent to 46-55 percent.
Observations with slow-release neuroleptics used in the treatment of inpatients of a psychiatric ward of a general hospital have been discussed. The comparative examinations were performed within a period of two and a half years in a total of 48 patients who were ranged into two groups at random. One group received Piportil, the other Haloperidol decanoate therapy. It has to be emphasized that Haloperidol is available also in its tablet form and as short-acting injection, and is readily accessible (contrary to other products), so it is a good basis for assessing the expectable effectivity of and tolerance to depot products. When comparing the two drugs, in the course of Piportil administration neuroleptic depression developed more frequently, in one case delirium occurred which unwanted effects did not develop in the course of the administration of Haloperidol decanoate. According to our observations on a low number of cases relapse also occurred more frequently in the Piportil-treated cases. Pathological change was not observed in the results of routine laboratory examinations in the course of the administration of any of the drugs. The advantages of the use of depot products have been discussed in detail from both the physician's and the patient's aspect. Due to their beneficial antipsychotic action schizophrenic clinical conditions and especially paranoid conditions constitute the major indication field of these drugs. The use of depot products in the treatment of patients refusing therapy means a dramatic change.
The efficacy of the use of moditen-depo and haloperidol decanoate as preventive anti-recurrence+ therapy was studied and compared in 2 groups of patients suffering from attack-like schizophrenia with frequent exacerbations. The cost-use analysis made it possible to establish their higher efficacy as compared to the routine maintenance therapy. Proceeding from the clinical, economic and socioeconomic indicators the use of haloperidol decanoate turned out more effective than the use of moditen-depo.
A significant number of chronic psychotic patients are readmitted to state mental hospitals each year due in large part to their inability or unwillingness to continue taking antipsychotic medication on a voluntary basis. This paper describes an ex post facto study comparing the effectiveness of fluphenazine decanoate, a long acting antipsychotic medication, with a variety of oral antipsychotics in reducing the number of readmissions of two groups of chronic psychotic patients to a state operated mental health facility. The results demonstrated that a group of 61 patients receiving fluphenazine decanoate had signigicantly fewer readmissions during the one year study period than did a comparison group on oral antipsychotics. The findings indicate that long acting antipsychotic medication, as part of an intensive outpatient treatment program, strongly militates against the tendency of chronic psychotic patients to discontinue treatment.
This paper reports a randomized, controlled, partially-blinded, flexible dose, parallel group, comparative study of the efficacy and tolerance of pipothiazine palmitate and fluphenazine decanoate in patients in remission from Schizophrenia over a 28 week period. The results show that pipothiazine palmitate is at least as efficacious and well-tolerated as fluphenazine decanoate in preventing relapses from maintained Schizophrenia.
An open clinical trial with Haloperidol Decanoate was carried out in order to determine its therapeutic efficacy, side effects, and tolerance. The sample population was a 30 male-and-female-psychotic-patient group (15 in-patients and 15 out-patients treated at a private psychiatric institution). A marked stabilizing effect with no relapses was observed. Therefore, it can safely be said that Haloperidol Decanoate helped in controling these patients satisfactorily, and getting a positive social reintegration.
We discontinued fluphenazine decanoate using a double-blind, crossover random order design, in 12 recent onset clinically stable schizophrenics who had been given fluphenazine decanoate 12.5 mg intramuscularly every 2 weeks for at least 1 year prior to drug withdrawal. Each condition (drug or placebo) lasted 12 weeks. Using a radioimmunoassay verified by comparison to a gas chromatographic-mass spectrometric method, plasma fluphenazine levels were measured every 2 weeks during drug continuation and drug withdrawal conditions. No patient relapsed over the 24-week period of the study. Mean fluphenazine levels between drug continuation and withdrawal conditions showed a progressively larger difference over time, although significant differences were not seen until week 8. By week 12 after drug withdrawal, 33% of subjects still showed notable plasma fluphenazine levels. On the basis of our preliminary findings, we suggest that 2-week intervals between injections may be too short and that wider intervals may achieve similar clinical results.
Urinary, fecal and biliary excretion, together with enterohepatic circulation, of radioactivity were studied after intravenous (50 mg eq/kg) and intramuscular (5 and 50 mg eq/kg) administration of [14C]-haloperidol decanoate in rats. The composition of urinary and biliary metabolites was also examined. The rate of excretion after intravenous administration lowered rapidly with the half-life of about 1.5 days and about 95% of dose was excreted in excreta within 10 days. Shortly after intramuscular administration, the rate of excretion lowered rapidly but then more gradually later (half-lives after administration of 5 and 50 mg eq/kg were 16.4 and 11.2 days, respectively). About 90% of dose was excreted within 42 days after intramuscular administration. About 1.6% of dose/day was excreted in the bile during 15-17 days after intramuscular administration, of which about 30% was reabsorbed within 24 h (enterohepatic circulation). The major urinary metabolite was p-fluorophenylaceturic acid and the biliary metabolite, glucuronide and sulfate of haloperidol. No unchanged decanoate was detected in the excreta.
In a six-week randomized, double-blind study the efficacy and side effects of perphenazine decanoate (PD) and perphenazine enanthate (PE) were evaluated and compared in 26 and 24 acute psychotic patients respectively. Of either formulation 100 mg were administered intramuscularly every two weeks. Maximum and minimum plasma concentrations of perphenazine were measured for each injection period using gas liquid chromatography. There was no statistically significant difference between PD and PE in terms of overall antipsychotic efficacy, assessed by means of the Brief Psychiatric Rating Scale (BPRS). However, when an 'Amelioration Score' (AMS) of at least 50% of the totally obtainable scores was defined as individual response criterion it was revealed that the PD group only one patient (4%) did not meet this criterion, compared with six patients (25%) in the PE group. Extrapyramidal side effects were significantly more pronounced in the PE-treated patients, who also required significantly higher amounts of antiparkinson medication. The mean maximum concentration of perphenazine in plasma was 5.0 nmol/l in the PD, and 10.6 nmol/l in the PE-treated patients. The ratio of the mean maximum to the mean minimum concentration was 1.41 and 4.02 in the decanoate and enanthate groups respectively. In the patients treated with PD there were signs of accumulation indicating the possibility of prolonging dosage intervals. The present study yielded further support to previous findings demonstrating that intramuscular administration of PD dissolved in sesame oil, in contrast to PE, results in even and flat plasma perphenazine concentration curves, which not only provides a stable antipsychotic effect but also most likely carry the responsibility for the low incidence of extrapyramidal side effects observed.
Serum neuroleptic levels were measured by radioreceptor assay in 24 schizophrenic patients maintained on fluphenazine decanoate. Clinical state was assessed at the time of neuroleptic level measurement and during the subsequent 6 months. Patients with persistent psychotic symptoms were on higher doses of fluphenazine decanoate than those in remission and had higher neuroleptic levels. Patients who relapsed during the 6 months after neuroleptic levels were measured did not differ in dose from those who stayed in remission but tended to have lower serum neuroleptic levels. These observations suggest that persistent psychotic symptoms in neuroleptic-maintained patients cannot be accounted for solely by inadequate treatment. Furthermore, in remitted patients serum neuroleptic levels may be a determinant of outcome.
Cholesteryl decanoate (C37H64O2) is monoclinic, space group P2I, with cell dimensions a = 12.931 (6), b = 9.066 (2), c = 30.22 (1) A, beta = 91.14 (4) degrees, and Z = 4. The atomic coordinates from cholesteryl laurate were used in an initial trial structure which was refined by block diagonal least-squares methods with 1846 observed X-ray reflections (R = 0.129). Molecules A and B have almost fully extended conformations, except at the ester bonds and towards the end of the decanoate B chain. The molecules are arranged in antiparallel array forming monolayers of thickness d001 = 30.22 A, with the molecular long axis making an angle of about 67 degrees with the layer interface. The crystal structure is very similar to that of cholesteryl nonanoate and cholesteryl laurate.