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PubMedDate not supplied

Water handling in patients receiving haloperidol decanoate.

OBJECTIVE: To determine whether water handling in patients receiving haloperidol decanoate (HD) was impaired. DESIGN: Prospective, controlled trial of water handling in patients without symptomatic hyponatremia receiving HD. Eligibility for study inclusion required that patients had received HD for at least 4 months, were not taking any medication reported to cause inappropriate antidiuretic hormone secretion or hyponatremia (excluding haloperidol), and would agree to participate in the study. An age- and gender-matched healthy control subject was enrolled for each study patient. Baseline laboratory values were obtained within 48 hours prior to the standard water-loading test to screen for abnormalities in electrolytes, kidney function, and liver function. A 20-mL/kg water-load test was administered to each patient. Urine volume and osmolality were measured every hour for 4 hours. SETTING: A community mental health (CMH) outpatient psychiatric facility for the patients receiving HD and Saint Mary's Health Services for the controls. PARTICIPANTS: Fifteen patients receiving HD from the CMH facility and 15 age- and gender-matched control subjects were enrolled. MAIN OUTCOMES MEASURES: Impaired water handling was defined as a failure to dilute urine to less than 100 mmol/kg or a failure to excrete more than 65% of a water load in 4 hours. RESULTS: Five patients receiving HD were excluded because of protocol refusal or violation. Five of 10 evaluable patients receiving HD had abnormal water handling. Two of these could not lower their urine osmolality to less than 100 mmol/kg, 2 could not excrete more than 65% of the water load, and 1 did not meet either criteria. None of the healthy volunteers had abnormal free water handling. The difference between the study patients and the control subjects was statistically significant (p = 0.0097). CONCLUSIONS: Fifty percent of our study patients receiving HD had abnormal free water handling. This finding, combined with our clinical observations of symptomatic hyponatremia in other patients receiving the drug, suggests the need to investigate the incidence of hyponatremia and to design a useful screening tool to identify patients at risk. In the meantime, clinicians should be aware of the potential for impaired water handling in patients receiving HD.

Adult↗
PubMed1981

Clopenthixol decanoate in schizophrenia.

Clopenthixol decanoate was given to 20 chronic schizophrenic patients for 11 months in doses ranging from 100 mg initially up to 1000 mg 3-weekly subsequently, according to clinical response and the occurrence of adverse effects. A further 3 patients received the depot injections for periods of 6 to 9 months. Improvement in individual symptoms was rated on a 4-point scale. Unwanted effects were recorded on a checklist and routine biochemical and haematological tests were carried out at the beginning and end of the treatment period. There were highly significant improvements in the mean overall symptom score and in the 5 single symptom scores (hallucinations, delusions, depression, aggressive behaviour and non-aggressive behaviour disturbance). The 2 'negative' symptoms of apathy and social withdrawal showed improvement up to 16 weeks but not at 11 months. The incidence of depression was less at the end of the study than at the time fo entry. Three patients stopped the drug after the sixth month because of extrapyramidal symptoms (2) or drowsiness (1). Three others developed severe extra-pyramidal side-effects. Unwanted effects, though recorded in 70% of patients--drowsiness and extrapyramidal symptoms were the commonest--were for the most part trivial, and were fewer and less severe than they were on entry to the study. There was no evidence of toxicity. It was considered that on the basis of this experience the drug was an effective, safe antipsychotic agent, warranting more extensive clinical trial.

Adult↗
PubMed1990

A double-blind comparison of oral amitriptyline and low-dose intramuscular flupenthixol decanoate in depressive illness.

Fifty-seven hospital out-patients with depressive symptoms were studied in a double-blind manner for up to 4 weeks, 30 whilst being treated with intramuscular flupenthixol decanoate (5 to 10 mg/fortnight) and 27 with oral amitriptyline (75 to 150 mg/day). The results of assessment using the Hamilton Rating Scale for Depression, the Leeds Self-Rating Scale for Depression and the Clinical Global Impressions severity scale showed that both therapies were effective in resolving depression in the patients studied. The two treatments were well tolerated and side-effect profiles were similar, dry mouth, faintness/dizziness and drowsiness being the most frequently reported adverse events. Extrapyramidal signs were seen in similar numbers of patients in each treatment group. One patient from each of the two groups was withdrawn from therapy before the end of the study because of adverse events.

Administration, Oral↗
PubMed2004

Effect of Nandrolone Decanoate on serum lipoprotein (a) and its isoforms in hemodialysis patients.

Malnutrition, anemia and increased atherosclerosis are the main causes of mortality in hemodialysis patients. Therapies designed to improve the disorders might therefore be expected to improve outcome. The effects of Nandrolone Decanoate (ND), in 64 stable hemodialysis patients, were studied with respect to the following parameters: nutritional status, hematological indexes, lipid profiles including serum levels of lipoprotein(a) [Lp(a)] in terms of differences in apolipoprotein(a) [apo(a)]. The patients were treated with ND at dose of 100 mg/I.M./week for 4 months. After 2 and 4 months of treatment the elevations in the serum levels of albumin (p < 0.0001), creatinine (p < 0.009), hemoglobin (p < 0.03), hematocrit (p < 0.03), cholesterol (p = 0.007) and triglyceride (p < 0.04) were noticed. Marked decrease in the concentration of high-density lipoprotein cholesterol (p = 0.007) and Lp(a) (p < 0.0001) were also found. These effects after 2 months of treatment withdrawal were relatively constant. By dividing patients according to the baseline Lp(a) levels and molecular weight of apo(a) isoform, it was noticed that the decrease in serum Lp(a) was significant in patients with high Lp(a) (> 30 mg/dl) than those of with low Lp(a) (< 30 mg/dl), irrespective of apo(a) molecular weight. It may be suggested that, ND has beneficial effect on nutritional status and treatment of anemia in hemodialysis patients. In spite the adverse effect of ND on lipid profile, it decreases Lp(a) mostly in patients with high serum Lp(a) preferently by the effect on apo(a) gene transcriptional activity.

Journal Article↗
PubMed1979

High dose flupenthixol decanoate in chronic schizophrenia.

In a double-blind trial, female 'drug-resistant' chronic schizophrenic in-patients were given high dose or standard dose flupenthixol decanoate for 13 weeks. Plasma flupenthixol levels showed a five-fold interindividual variation, but were consistently higher with the high dose. Analysis of final scores showed no statistically significant differences between groups with regards to mental state, ward behaviour and extrapyramidal side-effects. When compared with pre-trial scores, the extrapyramidal side-effects worsened significantly in the high dose patients and social withdrawal decreased in the standard dose patients. The mental state of a sub-group of patients, possibly drug resistant for pharmacokinetic reasons, improved significantly on the high dose over the 13 weeks.

Adult↗
PubMed1980

Intermittent pimozide versus fluphenazine decanoate as maintenance therapy in chronic schizophrenia.

In a double-blind trial, 34 male chronic schizophrenic day-patients or in-patients in a hostel ward continued on fluphenazine decanoate given mostly once fortnightly or were switched to pimozide, given on four days each week. Over nine months relapse rates were similar for both groups, and while fewer patients on pimozide were prescribed antiparkinsonian drugs one quarter developed buccolingual masticatory dyskinesia. Plasma pimozide levels suggested satisfactory drug compliance. Average plasma prolactin levels were within the normal rage for untreated men in one quarter of non-relapsing patients on pimozide and three quarters on fluphenazine.

Chronic Disease↗
PubMed1982

Once weekly pimozide versus fluphenazine decanoate as maintenance therapy in chronic schizophrenia.

In a double blind trial, 28 male chronic schizophrenic in-patients received either pimozide, given once weekly, or fluphenazine decanoate, given mostly once fortnightly. There was no difference in relapse rates over nine months. However, three-quarters of the patients on pimozide who completed the trial developed at least mild tardive dyskinesia. All patients on pimozide lost weight, the average loss being 5.4 kg (12 lbs). Plasma pimozide levels suggested satisfactory drug compliance. Plasma prolactin levels confirmed that in the pimozide group there was fluctuating dopamine receptor antagonism, while in the fluphenazine group average plasma prolactin levels throughout most of the interval between injections were at the upper limit of normal.

Adult↗
PubMed1986

Pharmacokinetics and therapeutic efficacy of haloperidol decanoate after loading dose administration.

For this open study, we selected 21 chronic psychotic female in-patients (16 of them schizophrenics) who were being maintained on oral neuroleptics. After a wash-out period, they were treated by intramuscular depot injections of haloperidol decanoate, once a month for four months. The dose was calculated from the previous oral dosage, and the amount of the first injection was double that of the three following injections. Relatively stable plasma levels of haloperidol were achieved with the first injection, and corresponded to those observed with oral medication. A very significant correlation was found between plasma level and the dose administered, but not between plasma level and therapeutic effect. The clinical condition of about two-thirds of the patients remained unchanged or improved, compared with the period of oral treatment. During the first two months of treatment, there was more rigidity and tremor, but from the third month, the extrapyramidal symptoms were less pronounced than during the period of oral neuroleptics.

Adult↗
PubMed1988

Plasma levels of fluphenazine decanoate. Effects of site of injection, massage and muscle activity.

Depot neuroleptics are now commonly used for maintenance therapy of schizophrenia. Their physicochemical composition makes them ideal for such use because they are long-acting and show stable blood levels for prolonged periods. Their absorption from the site of injection may, however, be affected by local muscle factors. This paper describes three such factors in relation to fluphenazine decanoate: varying the site of injection; massage of the injection site; and effects of muscular exercise. Our results suggest that fluphenazine pharmacokinetics are not significantly affected by any of these factors.

Adolescent↗
PubMed2005

A multicenter phase IIb study of a novel combination of intramuscular androgen (testosterone decanoate) and oral progestogen (etonogestrel) for male hormonal contraception.

The effect of a novel combination of oral etonogestrel (ENG) and im testosterone decanoate (TD) on suppression of gonadotropins and spermatogenesis as a potential lead for male contraception was investigated. Healthy male volunteers were randomized into two groups receiving 300 microg ENG daily and 400 mg TD every 4 (n = 55) or 6 (n = 57) wk for 48 wk. At wk 48, all men except one in the 6-wk group suppressed sperm concentration to less than 1 million/ml. Faster suppression occurred in the 4-wk group. Gonadotropins were suppressed in both groups and most consistently in the 4-wk group. During treatment, trough testosterone levels increased into the normal range in the 4-wk group but remained just below normal in the 6-wk group. All peak levels were within the normal range. After treatment cessation, recovery of sperm counts and gonadotropins to normal levels occurred in both groups. Minor effects on weight and cholesterol were noted. Fourteen subjects withdrew because of an adverse event with those possibly related to the study medication reported more frequently in the 6-wk group (nine vs. one). In conclusion, the combination of 300 microg ENG with 400 mg TD every 4 wk was superior in terms of efficacy, hormone profiles, and safety. This represents a promising approach to male hormonal contraception.

Administration, Oral↗
PubMed1989

Behavioral and electroencephalographic effects of a depot type neuroleptic fluphenazine decanoate, in rats.

The behavioral and electroencephalographic (EEG) effects of intramuscular fluphenazine decanoate (Fl-D) were investigated in rats and compared with those of fluphenazine enanthate (Fl-E) and fluphenazine HCl (Fl-HCl). It was clearly observed that 1) these two depot type neuroleptics reduced open-field activity, 2) antagonized methamphetamine-induced hyperactivity, 3) inhibited the conditioned avoidance response, and 4) produced catalepsy, for a substantially long period of time (4-35 d). Although both Fl-D and Fl-E significantly inhibited muricide in olfactory bulbectomized rats and impaired rotarod performance, these effects were relatively weak in potency and short-lasting (4 h-2 d). The EEG was changed to a drowsy pattern which consisted of high voltage slow waves following the injection of Fl-D and Fl-E. Fl-D significantly inhibited the EEG arousal response to auditory stimulation, but Fl-E did not. However, neither Fl-D nor Fl-E inhibited the EEG arousal response to electrical stimulation of the midbrain reticular formation and posterior hypothalamus. These results indicate that Fl-D has the same spectrum of pharmacological activity as Fl-E, except for its longer duration of action in antagonizing methamphetamine as well as in inhibiting the EEG arousal response to auditory stimulation.

Acoustic Stimulation↗
PubMed1979

Work capacity, contractile protein and quantitative electromyogram (EMG) changes following exercise or nandrolone decanoate treatment in experimentally induced muscle disuse atrophy in rats.

Anabolic steroid administration and planned exercise have been the two main methods applied to improve the function and morphology of atrophied muscle tissue. The effects of these two factors-specifically nandrolone decanoate administration and exercise by swimming on muscle weight, EMG activity, work capacity and on contractile protein content of rat gastrocnemius muscle, following experimentally induced atrophy by immobilization, were investigated. The results appear to support the conclusion that although both types of treatment obtain significant positive results exercise acts more effectively than the anabolic steroid in this respect.

Actomyosin↗
PubMed1975

Response of uremic patients to nandrolone decanoate.

The effect of anabolic steroid therapy on anemia in 13 women with and without kidneys undergoing chronic hemodialysis for renal failure was investigated. All but one of the six patients with kidneys demonstrated a noticeable increase in hematocrit level (6.4% to 14.6%). Of the anephric women, four of the seven also showed hematocrit level elevations, but these were less remarkable (3.1% to 6.4%). A majority of patients demonstrated increments in weight and serum creatinine measurements but no definitive alteration in serum blood urea nitrogen levels. The androgenic effects of nandrolone decanoate were minimal and well tolerated. We conclude that anabolic steroid therapy is effective in ameliorating the anemia of women undergoing hemodialysis, if given in a dose that produces minimal and tolerable untoward effects.

Adult↗
PubMed1992

Haloperidol decanoate pharmacokinetics in red blood cells and plasma.

Red blood cell (RBC) and plasma concentrations of haloperidol (H) and reduced haloperidol (RH) were determined in nine patients (five men, four women) who had been receiving monthly injections of haloperidol decanoate (HD) for at least 3 months. A very sensitive high performance liquid chromatography method was used to measure H and RH, which could be detected at levels as low as 0.1 ng/ml. Blood samples for H and RH were drawn at the end of weeks 1, 2, 3, and 4 of a 4-week cycle. Monthly HD dosages ranged from 50 mg to 200 mg. At each time point RBC H did not differ significantly from plasma H. RBC RH and plasma RH did not change significantly over time and were consistently lower than RBC H and plasma H. However, RBC RH levels were higher than plasma RH levels. Also, the ratios of RBC RH/H were higher than were the ratios of plasma RH/H, which reflect an accumulation of RH intracellularly. HD dosage was highly correlated with both RBC H and plasma H, but RBC RH and plasma RH were not significantly related to dosage at any time point. Significant correlations were observed between HD dosage and prolactin concentration at week 1 and between prolactin concentration and RBC H and plasma H at weeks 1 and 4. Blood concentrations of H and RH and the corresponding standardized areas under the curve were not significantly related to smoking.

Adult↗
PubMed1991

Minimal effective dose and relapse--double-blind trial: haloperidol decanoate vs. placebo.

Fifty-six chronic schizophrenic patients were randomized into haloperidol decanoate (HD) or placebo groups for 48 weeks of double-blind treatment. The double-blind trial was preceded by a 15-week single-blind run-in period, during which all patients were treated with 60 mg of HD (approximately corresponding to 3.6 mg orally/day) every fourth week (except for the second injection, which was given after 3 weeks). Eight relapses occurred during the run-in period, and seven other patients refused further participation. The remaining 41 patients were then treated double blind, either with HD, 60 mg/4 weeks (18 patients), or with placebo (23 patients). Two patients (11%) in the HD group and 16 (69%) in the placebo group relapsed during the 48-week double-blind period. The plasma concentrations of haloperidol were measured every fourth week in both groups. Steady state was reached after 11 weeks. The mean steady-state level was 6.3 nmol/L. In the placebo group, a 50% decrease in the mean haloperidol plasma concentration was seen 8 weeks after withdrawal of haloperidol. The haloperidol plasma concentration was a predictor of relapse. There was no statistical difference between the treatment groups regarding extrapyramidal symptoms. More biperiden, however, was used in the HD group, while the placebo patients took more sedatives. The results of this study show that the relatively low and fixed dose of 60 mg of HD every fourth week was superior to placebo in preventing relapse in schizophrenia.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1990

Clinical and toxicological profile of fluphenazine decanoate in elderly chronic schizophrenia.

Twenty elderly chronic schizophrenic inpatients of both sexes, age ranging from 60 to 73 years (mean age 63 +/- 0.81 years), diagnosed according to DSM III-R, were treated with fluphenazine decanoate, 12.5 mg intramuscularly, administered every 21 days for six months. Psychopathological features were assessed by means of the Brief Psychiatric Rating Scale at time 0 and then weekly. At 0, 6, 12, 24, 36, 48, 72h and 7, 14 and 21 days after each administration, extrapyramidal side-effects were evaluated using the Extrapyramidal Side-Effects Scale. Fluphenazine was significantly effective in treating symptoms such as emotional withdrawal, blunted affect, suspiciousness, thought disturbances, but not hallucinations. The most severe extrapyramidal side-effects occurred within the first two days of administration of fluphenazine, with a peak after 36 h, following the first four administrations of the drug, possibly related to early peak plasma concentrations. The severity of these effects was reduced after the fifth injection indicating the occurrence of tolerance mechanisms during long-term fluphenazine administration.

Aged↗
PubMed1990

Kinetics and clinical evaluation of haloperidol decanoate loading dose regimen.

We have evaluated the efficacy and safety of different dosing regimens of haloperidol decanoate (HLD). Eighteen patients were evaluated as part of our ongoing Therapeutic Drug Monitoring Program. Diagnoses were chronic schizophrenia (n = 12), bipolar with psychosis (n = 3), and others (n = 3). Patients were assessed prior to each HLD dose using the Clinical Global Impressions (CGI) rating scale. The total monthly HLD dose for our population was calculated based on a target conversion ratio of 20 times the previously administered oral haloperidol dose given in divided doses of 100 mg to 150 mg every 3 to 7 days until the full amount was administered. This HLD dosing pattern was repeated during the second month, but at a lower dose to compensate for drug accumulation. Despite this loading dose paradigm, significantly greater haloperidol plasma concentrations were present during oral haloperidol than during the first month of HLD therapy. This regimen achieves therapeutically equivalent plasma concentrations (Cps) more rapidly following conversion from oral haloperidol than standard dosing procedures. A series of cases and pharmacokinetic simulations are used to illustrate the therapeutic relationship of dosing to plasma concentrations.

Adult↗