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Biomedical subjects

S I Ankier

Publications and source records attributed to S I Ankier.

At least 37 records · Page 2Linked to original sources
PubMed1984

Trazodone--a comparison of single night-time and divided daily dosage regimens.

The antidepressant efficacy, influence on sleep variables and incidence of side-effects of trazodone (100-400 mg daily), given either as a single night-time dose or thrice daily, were compared in a double-blind, 4 week, parallel group, multicentre hospital study. Of 56 patients who entered the study, full data was available for 37, of whom 20 took the medication at night and the other 17 received divided doses during the day. The results showed equivalent therapeutic efficacy for the two dosage regimens and tolerance was good in both groups. For onset and also duration of sleep, significantly more patients in the single night-time group improved than worsened in response. Both groups of patients tended to report a more satisfying sleep and greater freshness on waking, although these latter effects were not statistically significant. For the group taking trazodone thrice daily, there was a trend for more complaints of side-effects, particularly dry mouth, headache and drowsiness which led to more of these patients requiring modification of dosage. Thus trazodone appears to have clinically useful sedative properties. It has relatively few side-effects and these are generally reduced by giving a single dose at night.

Adolescent↗
PubMed1984

An evaluation of possible interactions between ethanol and trazodone or amitriptyline.

The pharmacodynamic effects of single doses of trazodone (100 mg), amitriptyline (50 mg) or placebo either alone or with ethanol (0.5 ml/kg) were investigated in six healthy volunteers in a double-blind crossover study. Plasma concentrations of the drugs and ethanol were also measured. Pharmacodynamic tests were critical flicker fusion frequency threshold (CFF), choice reaction time (CRT), manual dexterity, a digit span test and visual analogue scales. Blood ethanol concentrations were not influenced by the co-administration of either antidepressant. tmax for trazodone was prolonged by ethanol but the other pharmacokinetic parameters for trazodone and amitriptyline were not influenced by ethanol. Trazodone and amitriptyline caused the expected profound depressant effects on CFF, CRT, manual dexterity and on the rating scales for drowsiness, 'clear-headedness', aggression and disinhibition. Ethanol alone impaired manual dexterity, increased drowsiness, reduced 'clear headedness' and also tended to reduce feelings of aggression. In combination with either trazodone or amitriptyline, ethanol caused little additional effect except in the case of manual dexterity which was further impaired. This result may reflect the profound effects of the antidepressants alone and does not suggest that it is safe for patients receiving antidepressant medication to take ethanolic drinks.

Adult↗
PubMed1984

Trazodone. A comparative clinical and predictive study.

The clinical efficacy and tolerability of trazodone and amitriptyline were compared in 74 hospital patients suffering from depressive illness. The daily doses of trazodone and amitriptyline were 150-300 mg and 75-225 mg, respectively, with half-strength capsules for patients over the age of 65 years. Twenty-five and 29 patients receiving trazodone and amitriptyline, respectively, completed the 6 week treatment period. Antidepressant activity was measured using the Hamilton Depression Rating Scale (HDRS), the Zung Scale of Depression, visual analogue scales and a Global Assessment Scale. Trazodone and amitriptyline were both effective but not statistically different from each other in terms of antidepressant action. Moreover, patients with neurotic or endogenous depression responded equally well on either treatment. Trazodone was less troublesome in respect of the persistent dry mouth and severe adverse psychiatric reactions which occurred with amitriptyline. Patients should be advised to take trazodone after meals.

Adult↗
PubMed1984

Trazodone and mianserin in general practice.

In a double-blind, noncrossover study, general practice patients suffering from depression were treated with either trazodone (100-200 mg, nocte ) or mianserin (60-120 mg, nocte ) for 6 weeks. For entry into the study, a minimum score of 14 on the 17-point Hamilton Depression Rating Scale ( HDRS ) was necessary. By random allocation, 125 patients (61 on trazodone and 64 on mianserin) entered the study. Altogether there were 43 withdrawals, of whom 31 (72%) had received mianserin. At least one of the reasons for 22 withdrawals from the mianserin group was an unacceptable side effect, frequently being daytime drowsiness. In contrast, only 5 of the trazodone group withdrew because of side effects. These differences in the withdrawal rates for those patients entering the study were statistically significant (p less than 0.001). A total of 82 patients completed treatment and entered the analysis for efficacy; 49 on trazodone and 33 on mianserin. Results show that both treatments were equally effective in reducing symptoms of depression and anxiety. Thus, the mean HDRS score was 21.3 and 21.5 for trazodone and mianserin, respectively, at the start of treatment which decreased to 6.2 and 5.9, respectively, at the end of 6 weeks. The mean Zung self-rating anxiety scores for trazodone and mianserin were 45.6 and 44.4 at the start of treatment and 33.6 and 31.1 at the end of the study. The results suggest that, on the basis of fewer significant side effects, trazodone is more acceptable to mianserin in treating depression, with or without anxiety, in general practice patients.

Adult↗
PubMed1984

A double-blind non-crossover placebo-controlled study between group comparison of trazodone and amitriptyline on cardiovascular function in major depressive disorder.

The cardiovascular effects of trazodone ( TZD ), amitriptyline (AMT) and placebo were studied in out-patients with major depression. AMT was shown to have the expected effects on the electrocardiograph and on systolic time intervals consistent with its proven anticholinergic and quinidine-like properties. TZD , in contrast, had no quinidine-like effects and minor effects on systolic time intervals. However, it was not without any cardiovascular effects. Although TZD was shown to be a safer preparation than the reference drug AMT, long-term monitoring is needed to explain the minor effect on heart rate and T wave changes.

Adult↗
PubMed1984

A comparison of the hypnotic activity of loprazolam, temazepam and placebo in general practice.

One hundred and ninety-seven patients exhibiting a disturbed sleep pattern were recruited by thirty-five general practitioners into this single-blind randomized parallel group multicentre study. There were twelve patient withdrawals or drop-outs leaving sixty-one, sixty-three and sixty-one patients who, following 2 nights on placebo as baseline, completed 5 consecutive nights of treatment on loprazolam (1 mg), temazepam (20 mg) and placebo, respectively. Loprazolam and temazepam were found to have similar hypnotic activity with both treatments being superior to placebo. There was no statistical difference in the side-effect profile of the three treatment groups.

Adolescent↗
PubMed1984

A multicentre hospital study to compare the hypnotic efficacy of loprazolam and nitrazepam.

A multicentre, parallel group hospital study was carried out in 190 subjects with insomnia to compare the efficacy, incidence of hangover and the side-effects of loprazolam and nitrazepam. Following 2 nights single-blind phase on placebo, loprazolam (1.0 mg), nitrazepam (5.0 mg) or placebo was administered double-blind for 7 consecutive nights. Visual analogue scales and questions were used to rate efficacy. There was no statistically significant difference between loprazolam and nitrazepam for 'ease of getting to sleep', 'restfulness of sleep' and 'depth of sleep'. Like nitrazepam, loprazolam diminished the number of periods of wakefulness and made it 'easier to get to sleep again'. Subjective evaluation showed that hangover was not a feature of loprazolam. It did not affect morning alertness and patients thought they had improved balance and co-ordination while on this drug. These findings are in keeping with the evidence of other workers who have shown only minimal psychomotor impairment, if any, with loprazolam (1.0 mg). There was no statistically significant difference between treatments with respect to frequency or incidence of side-effects.

Adolescent↗
PubMed1984

Comparison of trazodone and mianserin in depressive illness.

In a multi-centre study, the antidepressant efficacy and incidence of on-therapy events of trazodone (100 to 400 mg daily) and mianserin (30 to 120 mg daily) was compared using a double-blind pre-determined randomized parallel group design in depressed patients unresponsive to placebo after a 7-day screening period. Of the 111 patients who entered the study, 27 patients were withdrawn or defaulted. The withdrawal rate was similar between the treatment groups. The results of depression rating scale assessments showed that trazodone and mianserin were similar to each other for efficacy in patients judged to be suffering from severe or mild/moderate depression whether of the endogenous or reactive type. For all on-therapy events, there were no major differences between the treatments, with drowsiness being the most frequently reported side-effect.

Adult↗
PubMed1984

Electrophysiological and haemodynamic changes with trazodone, amitriptyline and placebo in depressed out-patients.

Fourteen out-patients with major depressive disorder completed a double-blind, randomized, parallel group study using trazodone (n = 6), amitriptyline (n = 5) and matching placebo (n = 3). The average daily doses used were 223 mg and 95.3 mg for trazodone and amitriptyline, respectively, over the 28-day treatment period. Cardiovascular function was monitored with high speed ECG and by determining systolic time intervals. No significant effects of either drug on supine or standing blood pressure were demonstrated. Trazodone increased QTc on Day 1 only, and reduced heart rate and increased the PR interval on Day 15; these effects had disappeared by Day 29. Amitriptyline markedly increased heart rate, PR interval and QTc, and reduced T wave amplitude on Days 15 and 29. Trazodone had no consistent effect on systolic time intervals except to increase the LVET index, whereas amitriptyline increased both PEP index and PEP/LVET ratio on Days 15 and 29. It is concluded that amitriptyline had a much more marked effect on cardiac function than did trazodone.

Adult↗
PubMed1983

A double blind comparison of the efficacy and safety of trazodone and imipramine in endogenous depression.

In a 6-week double blind non-crossover study, trazodone and imipramine have been compared in the treatment of patients with severe endogenous depression. By random allocation, 13 patients entered each treatment group. The mean maintenance dosage of trazodone was 300 mg (range 200-350 mg) and of imipramine 160 mg (range 150-175 mg). Some evidence is presented to suggest that trazodone may have an earlier anxiolytic effect than imipramine by day 4 and a greater antidepressant effect by day 22 of treatment. Apart from the frequency of impaired visual accommodation being significantly greater in the imipramine group, there were no differences between the treatments with respect to side-effects. No abnormalities were found from laboratory investigations and ECG assessments.

Adult↗
PubMed1983

Effects on psychological performance of the benzodiazepine, loprazolam, alone and with alcohol.

The effects of a new 1,4 benzodiazepine hypnotic, loprazolam (1.0 mg) and alcohol (0.7 g/kg body weight) were investigated over a 15 h period in eight healthy male medical students, in a placebo controlled balanced design. Loprazolam when given alone impaired performance on a manual dexterity task, on a test of mental arithmetic, on a tracking task and it impaired memory as judged by the name and address memory test. Given alone, alcohol impaired performance on the simple reaction time task and on the tracking task. Performance on the memory test and choice reaction time test actually improved. No evidence was found suggesting a potentiation of effect when loprazolam and alcohol were given together. However, (a) on the manual dexterity task the alcohol, having no effect on its own, alleviated the loprazolam-induced impairment. (b) In the tracking task both alcohol and loprazolam impaired performance when given alone but not when given together. (c) The memory test was impaired by loprazolam, improved by alcohol and the effect of the combination is the expected sum of the two effects. Similarly for the arithmetic task the effect of the combination of the alcohol and loprazolam effects is the expected sum of the independent effects. The bulk of the evidence on the interaction suggests that alcohol mitigates the effects of loprazolam. In no sense could the drug be said to be having a sobering influence.

Anti-Anxiety Agents↗
PubMed1983

Pharmacokinetic and pharmacodynamic characteristics of trazodone in the elderly.

The pharmacokinetic and some pharmacodynamic characteristics of a single oral dose of 100 mg trazodone were compared in young and elderly volunteers. The maximum plasma concentration of trazodone was similar in both age groups. The time to maximum concentration was apparently prolonged in four subjects who swallowed the capsule with a minimal volume of fluid. This may have been due to the capsule being retained in the oesophagus. The terminal phase half-life of trazodone was significantly prolonged (P less than 0.05) and area under the plasma concentration-time curve was significantly larger (P less than 0.01) in the elderly. Apparent oral clearance was significantly reduced (P less than 0.01) in the elderly. Measurement of critical flicker fusion threshold and subjective assessment of alertness using a visual analogue scale, confirmed the sedative effect of trazodone in both age groups. The elderly subjects were less alert for a longer period following drug administration than the young. The differing pharmacokinetic and pharmacodynamic characteristics of trazodone in the young and elderly may be due to an age-related reduction in hepatic drug-metabolising activity, a difference in regional distribution or a change in CNS sensitivity to the drug.

Adult↗
PubMed1983

A comparative bioavailability study of Molipaxin capsules and a trazodone liquid formulation in normal volunteers.

The pharmacokinetic parameters of Molipaxin capsules and a trazodone liquid formulation have been compared in healthy volunteers. The mean area under the plasma concentration/time curve was 10.07 micrograms h ml-1 and 10.44 micrograms h ml-1, for Molipaxin capsules and trazodone liquid, respectively. The difference was not statistically significant. There was considerable individual variation between the observed maximum plasma concentration of Molipaxin capsules and trazodone liquid but the mean values of 1.61 micrograms/ml and 1.66 micrograms/ml, respectively, were very similar. The time to observed maximum plasma concentrations varied from 15 min to 4 h, but there was no statistical difference between the two formulations. The terminal phase half-life was 7.16 h for Molipaxin capsules and 6.73 h for trazodone liquid. The difference was not statistically significant. Molipaxin capsules and trazodone liquid have similar kinetic profiles and they are considered to have comparable bioavailability. Tolerance to the two formulations was similar.

Adolescent↗