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PubMed1998

Effects of combined treatment with etidronate, nandrolone-decanoate and calcium on bone mineral density in postmenopausal women.

The objective of this retrospective study was to see whether the effect on bone mineral density (BMD) and response to the intermittent cyclic treatment with etidronate (E) + nandrolone-decanoate (ND + calcium (Ca) (group A--combined regimen--400 mg E daily for 2 weeks, followed by 500 mg Ca daily for the next 10 weeks + 50 mg ND once a month i.m., for 3 months in every other E cycle) was of greater benefit than cyclic E + Ca treatment (group B--standard regimen--E + Ca given in the same manner as in group A) or Ca treatment alone (group C--calcium regimen--500 mg Ca daily, continuously for 1 year). Group A comprised 30, group B 27 and group C 26 postmenopausal women with spinal BMD > or = 1 standard deviation below young adult mean (T score < or = -1) without vertebral fractures. BMD was measured by dual energy X-ray absorptiometry in the lumbar spine and femoral neck before (baseline values) and after one year treatment period. A similar, statistically significant increase in BMD was noted at lumbar spine in groups A and B (3.6% and 3.8%, respectively) and at femoral neck in groups A and B (1.7% and 2.5%, respectively). In group C, the bone loss at lumbar spine was prevented but no significant increase was recorded (0.3%) and at femoral neck an insignificant decrease in BMD was recorded (-0.3%). Percentages of change from baseline were significantly higher in groups A and B in respect to those in group C but there were no significant differences between groups A and B either at lumbar spine or at femoral neck. In about 30% of women from groups A and B, spinal BMD increased by more than 4.2% ("real" responders to the given therapy). A femoral BMD increase of more than 5.6% was recorded in about 13% of women from groups A and B. In group C, no such increase was recorded. In conclusion, combined intermittent cyclical regimen of E + ND + Ca has not proven to be superior to the intermittent cyclic regimen of E + Ca.

Anabolic Agents↗
PubMed1976

Very high dose fluphenazine decanoate: a controlled trial in chronic schizophrenia.

In a double-blind trial of six months' duration, a very high dose (VHD) regimen of fluphenazine decanoate (250 mg weekly) was compared with a standard dose (SD) regimen (12.5 mg weekly) in 50 chronic schizophrenic patients. The rating scales used included the Brief Psychiatric Rating Scale and the Wing Ward Behavior Scale. Both treatment groups improved during the trial, but there was no significant difference between them. The VHD regimen, however, exerted better control of the psychosis in that it had fewer patient dropouts and fewer "additional treatments" prescribed. Some of the patients receiving standard doses were probably not receiving adequate antipsychotic drug dosage. No predictors of clinical response could be defined. Extrapyramidal side effects were not significantly higher in the VHD group.

Adolescent↗
PubMed1977

Fluphenazine decanoate, oral fluphenazine, and placebo in treatment of remitted schizophrenics. II. Rating scale data.

This study of patients with remitted chronic schizophrenia in an aftercare clinic was designed to test whether such patients require maintenance antipsychotic medication. A previous report showed that the group receiving active medication, fluphenazine decanoate and oral fluphenazine, had far fewer relapses; but the former group had a high incidence of akinesia. This present report presents rating scale data substantiating these two findings: (1) patients terminated on clinical grounds because of a schizophrenic relapse showed rating scale changes consistent with that diagnosis; and (2) the patients removed due to severe akinesia showed a worsening on items selected a priori to measure akinesia, and when compared to survivors on the same items, showed significant differences--thus confirming our clinical judgments.

Administration, Oral↗
PubMed1987

Low- and conventional-dose maintenance therapy with fluphenazine decanoate. Two-year outcome.

We evaluated the effectiveness and the side effects of what we defined as low (5-mg) and conventional (25-mg) doses of fluphenazine decanoate administered every two weeks in a double-blind comparison. Subjects were 66 patients who fulfilled DSM-III criteria for schizophrenic disorder. Evaluation of the survival with each dose revealed no significant difference at one year, but significantly better survival was seen with the 25-mg dose (64%) than the 5-mg dose (31%) at two years. There was no significant difference in survival when the clinician was permitted to make a dosage adjustment up to 10 mg in the low-dose group and 50 mg in the higher-dose group when the patient demonstrated evidence of a symptomatic exacerbation. Patients assigned to the higher dose appeared to feel more uncomfortable during the early months of the study, as indicated by significantly higher scores on subscales of the Hopkins Symptom Checklist-90R and higher side effect scores for retardation and akathisia. Implications for clinical practice are discussed.

Adult↗
PubMed1975

Effect of nortestosterone decanoate on red cell 2,3 diphosphoglycerate and hematocrit in hemodialysis patients.

The effects of intramuscular 200-mg nortestosterone decanoate (ND) on red cell 2,3 diphosphoglycerate (DPG) concentration and packed cell volumes (PCV) were compared in 9 patients undergoing chronic hemodialysis for renal failure and in 18 control patients undergoing hemodialysis but not receiving ND. Subjects had received the drug 4.3 plus or minus 0.3 (SEM.) months at the time of DPG determinations. DPG was similar in treated patients and in the control subjects: 6.27 plus or minus 0.22 mM/L RBC and 6.16 plus or minus 0.23 mM/L RBC, respectively. The initial PCV was also similar: 21.72% plus or minus 1.36 and 20.13% plus or minus 0.91. Although the mean PCV during treatment was higher for 5 of 9 ND-treated patients (p smaller than 0.01), the final PCV prior to termination of therapy was greater than the initial pretreatment PCV in only 2 of these 5 patients (p greater than 0.05). We conclude that 200 mg ND weekly has no effect on the red cell DPG and a transient unsustained effect in raising the PCV in male chronic hemodialysis patients over a 5-month period of treatment.

Adult↗
PubMed1999

TPD, FTIR, and Molecular Adsorption Studies of Calcium Hydroxyapatite Surface Modified with Hexanoic and Decanoic Acids.

The surface of synthetic calcium hydroxyapatite Ca10(PO4)6 (OH)2 (CaHAP) particles was modified with hexanoic CH3(CH2)4 COOH (HA) and decanoic CH3(CH2)8COOH (DA) acids in hexane and the resulting materials were characterized by various means. XRD pattern, specific surface area, and morphology of the CaHAP particles were essentially not altered by the modification. FTIR and TPD results indicated that HA and DA molecules are hydrogen-bonded to the surface P-OH groups of CaHAP in three adsorption types. The surface of modified particles became hydrophobic. When the modified samples were outgassed at 500 degrees C, HA and DA were removed and the surface P-OH groups were revived. The modified material adsorbed much less H2O and CO2 than the unmodified one. Copyright 1999 Academic Press.

Journal Article↗
PubMed1986

Fluphenazine plasma levels in patients receiving low and conventional doses of fluphenazine decanoate.

Plasma fluphenazine concentrations (FLU) were measured in 45 patients with schizophrenic disorders who participated in a double-blind comparison of 5 and 25 mg fluphenazine decanoate (FD). The rise in plasma level of FLU 24 h after a "test dose" was significantly correlated with steady state FLU concentration at 12 weeks (for 5 mg patients, r = 0.45, P = 0.04; for 25 mg, r = 0.78, P = 0.005). Patients who had low FLU at baseline required nearly 6 months to reach a steady state when they received 25 mg. Patients who received 5 mg and had low FLU at baseline continued to demonstrate relatively low plasma levels for the entire 1st year. Although the mean FLU at 6 months was lower for patients who relapsed during the subsequent 18 months (0.57 ng/ml for relapsers vs 1.01 ng/ml for nonrelapsers), this difference was not statistically significant. When plasma levels from both dosage groups were combined, FLU at 12 weeks correlated significantly with factor scores for akinesia (r = 0.52, P = 0.002) and BPRS cluster scores for retardation (r = 0.52, P = 0.002). These results indicate that the measurement of fluphenazine plasma levels may be useful in determining when patients treated with FD are receiving drug doses which are likely to cause discomforting side effects.

Adult↗
PubMed1987

The sulfoxidation of fluphenazine in schizophrenic patients maintained on fluphenazine decanoate.

Highly sensitive radioimmunoassays were applied to study the sulfoxidation of fluphenazine in 30 schizophrenic patients maintained on either 5 mg or 25 mg fluphenazine decanoate by intramuscular injection every 14 days over a period of 6 months. The presence of the sulfoxide metabolite was detected in all but one of the patients, such that 97% of the 340 plasma samples analysed contained the metabolite. Interpatient variations in plasma levels of fluphenazine, fluphenazine sulfoxide, and in drug to metabolite plasma level ratios were several fold higher than the corresponding intrapatient variations at both dosages. There were statistically significant tendencies for mean plasma fluphenazine levels to rise and mean plasma sulfoxide levels to fall over the 6-month period of study among patients on the high dose, consistent with our previously reported observation that it takes 3-6 months to establish a steady state of fluphenazine with this dosage regimen. By contrast, there were no statistically significant changes in mean plasma levels of either fluphenazine or its sulfoxide in patients on the low dose. Nevertheless, there was a significant rise in fluphenazine to fluphenazine sulfoxide mean plasma level ratios in both dosage groups. It is difficult to assess the significance of the changes in the drug to metabolite ratios with time, since there are no kinetic data on the phase II metabolism (conjugation) of fluphenazine or fluphenazine sulfoxide. This study shows that sulfoxidation is an important major pathway in the metabolism of intramuscularly-administered fluphenazine, and implies that metabolic sites other than gut wall are also involved in the process.

Fluphenazine↗
PubMed1985

Plasma levels of fluphenazine during fluphenazine decanoate treatment in schizophrenia.

The authors measured plasma fluphenazine levels in 20 schizophrenic patients receiving 25 or 50 mg fluphenazine decanoate (FPZ-D) by IM injection every 2 weeks. The plasma levels were determined by a sensitive gas-liquid chromatographic (GLC) assay with a nitrogen detector device developed in their laboratory. Using this chemical assay method, they replicated the finding of a sharp initial plasma peak within 24 h after the injection followed by a low but rather stable plasma level as previously reported by nonchemical assay methods. The interval plasma levels (averages of day 4-10 after injection) ranged from 0.17-0.61 ng/ml in 10 patients who received 25 mg; and 0.20-0.93 ng/ml in 7 patients who received 50 mg FPZ-D every 2 weeks. This four-fold variation in plasma levels during FPZ-D injection was smaller than previously reported levels achieved with oral antipsychotic drug treatment. Based on the study of plasma levels achieved with FPZ-D injection and oral FPZ-H (fluphenazine HC1) in 6 patients, the dosage requirement of FPZ-D appeared to be difficult to predict from the oral dosage of FPZ-H in the same patient. Two weeks past injection, fluphenazine was undetectable in approximately half the samples with the GLC method. Thus, radioimmunoassay or radioreceptor assay, which also measures metabolites, might be more suitable for the study of plasma levels in patients receiving FPZ-D injection.

Adolescent↗
PubMed1983

Steady-state serum concentrations after cis (Z)-flupentixol decanoate in viscoleo.

Serum concentrations of cis(Z)-flupentixol have been measured in patients on cis(Z)-flupentixol decanoate injections during successive dosage intervals of 2-4 weeks. The calculation of the fluctuation of the serum concentration in the dosage interval indicates that each individual patient should have his own dosage interval. For the 2-week group a significant correlation was found between weekly dose and preinjection concentration (r = 0.79) although an interindividual variability of X 4 was found. For this group the relative within-patient variation in the pre-injections concentration was calculated to be 9.6%, showing that a constant dosage regimen in the individual patient leads to an almost constant drug load.

Adult↗
PubMed1985

Zuclopenthixol decanoate in schizophrenia: serum levels and clinical state.

Serum concentrations of zuclopenthixol were determined in a group of 20 patients treated with a depot preparation, zuclopenthixol decanoate in Viscoleo. Clinical assessments according to a Clinical Global Impression (CGI) scale, Comprehensive Psychological Rating Scale (CPRS), 16-item subscale for schizophrenia, and the UKU side effect scale were performed on 3 consecutive days of injection. The serum concentrations showed a limited individual variation and a high and significant correlation between dose and serum concentration. One patient had a particularly high serum concentration of zuclopenthixol. This patient also had an elevated concentration of the N-dealkyl metabolite, but a low concentration of the sulphoxide. For serum concentrations versus clinical state and side effects some significant correlations were found. All correlations were positive, which means that the higher the serum concentration the poorer the clinical state of the patient. We think that this probably reflects a common clinical pattern of increasing the dose, when the antipsychotic response is unsatisfactory. The study also showed that for moderately ill patients, who were given the optimum dose of drug, the subgroup of patients not experiencing side effects had significantly lower serum concentrations than the subgroup with side effects.

Adult↗
PubMed1982

Serum concentrations of cis(Z)-flupentixol and prolactin in chronic schizophrenic patients treated with flupentixol and cis(Z)-flupentixol decanoate.

Nine chronic schizophrenic patients selected from three hospital departments were treated with flupentixol (orally and IV) and cis(Z)-flupentixol decanoate in Viscoleo (IM) in a three-phase pharmacokinetic study. Oral administration (single and repeated dosage) showed a relatively slow absorption with maximum serum concentration around 4 h after administration. Intravenous injection indicated multicompartment kinetics for cis(Z)-flupentixol. The biological half-lives calculated after the different doses were the same, indicating that the pharmacokinetics of cis(Z)-flupentixol does not differ between single and repeated administration and does not change when moderately higher doses are given. The bioavailability of orally administered cis(Z)-flupentixol was calculated to be about 40% with IV injection as reference. After IM administration maximum serum concentration was seen between 4 and 10 days in most patients. Calculation of a disappearance half-life gave very variable results, indicating that the release of the drug from the oil depot is not a monoexponential process. The intramuscular depot had a much lower bioavailability than IV injection, which means that steady state has not been obtained after 8 weeks of depot treatment. Serum prolactin concentrations were elevated during neuroleptic treatment, but no correlation was found between prolactin concentrations and the serum concentrations of cis(Z)-flupentixol. A correlation between the changes in clinical ratings and concentrations of cis(Z)-flupentixol or prolactin was not found.

Administration, Oral↗
PubMed1983

Serum concentrations of the isomers of clopenthixol and a metabolite in patients given cis(Z)-clopenthixol decanoate in viscoleo.

Cis(Z)-clopenthixol decanoate in Viscoleo (Sordinol Depot, Cisordinol Depot, Clopixol Inj.) was given intramuscularly to nine schizophrenic patients with dosage intervals of 1 or 2 weeks. Serum concentrations of the two geometric isomers of clopenthixol and its N-dealkyl metabolite were recorded in two successive dosage intervals. Significant correlations were found for dose vs area under the serum concentration curve and vs serum concentrations measured on individual days. The last mentioned concentrations are good measures of the area under the serum concentration curve, which expresses the drug load of the patient. The serum concentration curves in two successive dosage intervals were very similar. Maximum serum concentration was seen 5-7 days after injection and the mean maximum/minimum fluctuation was 1.6 with the 2-week dosage interval. The finding of very low amounts of the trans(E)-isomers of clopenthixol and the N-dealkyl-metabolite shows that isomerization of the cis(Z)-compounds into the corresponding trans(E)-isomers does not take place within the organism.

Adult↗
PubMed1995

Persistent catalepsy associated with severe dyskinesias in rats treated with chronic injections of haloperidol decanoate.

Patients who develop persistent parkinsonism while on chronic neuroleptic therapy may be predisposed towards the development of tardive dyskinesia (TD). We investigated this issue in an animal model of TD by examining the association between catalepsy and the syndrome of neuroleptic-induced vacuous chewing movements (VCMs). VCMs were measured every 3 weeks for 33 weeks while rats received injections of haloperidol decanoate. Catalepsy was measured after the second through the seventh injections of the depot neuroleptic. There were no correlations between the severity of catalepsy scores after the second or third injections of haloperidol and the severity of the overall VCM syndrome. However, the severity of the catalepsy score following the third through seventh injections of haloperidol strongly correlated with the concurrent number of VCMs. Persistent high catalepsy scores across the six catalepsy rating sessions were strongly associated with the development of persistent severe VCMs. These findings suggest that, to the extent that persistent parkinsonian signs in humans are associated with a propensity towards the development of TD, the VCM syndrome in rats is at least a partially faithful animal model of this relationship.

Animals↗
PubMed1990

Increases in rat striatal preproenkephalin mRNA levels following chronic treatment with the depot neuroleptic, haloperidol decanoate.

Studies of the effects of chronic neuroleptic drug treatment have consistently demonstrated enhanced transcription and translation of the preproenkephalin gene in the rat striatum. However, all of these studies have used daily ip drug treatments and none have evaluated the effects of chronic depot neuroleptics. With these drug treatments, dopamine receptor blockade undergoes less variability as a result of sustained steady-state blood levels of the neuroleptic. Therefore, as a result of the increasing utilization of depot neuroleptics therapeutically, we examined the effects of haloperidol decanoate on striatal preproenkephalin mRNA levels. As with daily ip drug injections, the depot preparation was found to increase the levels of this mRNA to an apparent new steady-state level twice that of controls, by 3 days and sustaining this steady-state for the 14 day observation period. These data indicate that both continuous and fluctuating patterns of dopamine receptor blockade result in activation of the preproenkephalin gene.

Animals↗
PubMed1982

Effects of fluphenazine decanoate (a long-acting phenothiazine) on serum prolactin and amphetamine-induced behavioural changes.

A single injection of fluphenazine decanoate (FD) antagonized effects of acute d-amphetamine (2.5 mg/kg) for a variable period of time (4 to 28 days), depending upon the dosage of the neuroleptic used (2.5 or 5.0 mg/kg) and the behavioural parameter(s) monitored. Locomotion and rearing were antagonized for a longer duration than was sniffing. Normal locomotor response to amphetamine was attained 12 and 28 days following the administration of 2.5 and 5.0 mg/kg FD, respectively. However, the 2.5 mg/kg FD group displayed significantly more locomotor activity on days 20 and 24 post-treatment. A similar supersensitive response was not demonstrable with the higher dose of FD (5.0 mg/kg), or with the other behavioural measures. The prompt and pronounced elevation of serum prolactin returned to within the normal range by days 4 and 14, following administration of 2.5 and 5.0 mg/kg FD, respectively. These results indicate that the behavioural paradigm is more sensitive in monitoring the effects of FD and could serve as a useful model in investigating the dose- and time-related effects of other long-acting neuroleptics.

Amphetamine↗
PubMed1987

Fluphenazine decanoate in acute and maintenance therapy of schizophrenia.

1. The knowledge of the pharmacokinetic profile of fluphenazine decanoate (FPZ-D) suggested it was suitable for treatment of schizophrenic patients not just during the maintenance phase of the disease but also during acute relapses. 2. 27 acute schizophrenic in-patients (diagnosed according to the DSM III) were treated with FPZ-D, 25 mg i.m. with repeated administrations (after 2, 4, 30 days). 3. FPZ-D proved effective in all cases, already after the second day and particularly on Brief Psychiatric Rating Scale items such as delusion, hallucinations, hostility. 4. Extrapyramidal side-effects, appeared in about 40% of the patients. 5. The use of the drug both in the acute phase and maintenance schizophrenia therapy is envisaged, overcoming the problems deriving from the rejection by patients of any therapeutic tool and consequently the therapeutic "milieu".

Acute Disease↗
PubMed1990

Haloperidol decanoate in chronic schizophrenia: a study of 12 months with plasma levels.

1. Clinical activity, extrapyramidal side-effects were evaluated in 22 schizophrenic out patients diagnosed according to DSM III and treated with haloperidol decanoate (50-300 mg i.m. monthly dose) for 12 months. 2. BPRS total scores did not show significant fluctuations showing a clinical stability of the patient population. 3. Patients with a duration of illness greater than 10 yrs (Group 2) showed significant (p less than 0.01) higher EPSE total scores compared to those with a duration of illness less than 10 yrs (Group 1). 4. A positive correlation was found between the administered dose and haloperidol plasma levels. 5. Patients from Group 2 reached the steady-state more slowly and showed a lower total L/D ratio compared to those from Group 1. 6. The pharmacokinetic approach seems desirable in order to adjust the dose and avoid schizophrenic relapses.

Adult↗