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Biomedical subjects

M T Isaac

Publications and source records attributed to M T Isaac.

8 recordsLinked to original sources

One year real world prospective follow-up study of a major depressive episode of patients treated with paroxetine and pindolol or paroxetine for 6 weeks.

The objective of our study was an assessment of outcome in a 1 year 'real world', prospective follow-up study of patients who were treated with paroxetine 20 mg plus pindolol 7.5 mg or paroxetine 20 mg plus placebo for 6 weeks. Eighty patients recruited to a double-blind placebo-controlled randomized 6 weeks study of paroxetine and pindolol were followed up for 6 months and interviewed after 1 year. A Kaplan-Meier survival analysis of the patients who relapsed having taken paroxetine and pindolol, compared with those who relapsed having taken paroxetine and placebo, shows that the pindolol group had a better clinical outcome. After 1 year patients who had responded to medication by 2 weeks had done better than the rest and they had been more compliant with medication for 6 months. There are indications that the earlier a patient responds to medication, the better the long-term outcome.

Adult↗

Cost effectiveness study of a year follow-up of selective serotonin reuptake inhibitor (SSRI) and augmentor combination compared with SSRI and placebo.

We describe a method for evaluating the value of increased cost of pharmacological augmentation that, taken for 6 weeks, accelerates the action of an antidepressant. We test the hypothesis that, if onset of action is taken into account, any added direct costs of the augmenting agent are offset by longer term cost effectiveness. Data to illustrate the method were based on a double-blind randomized placebo controlled study, in which 80 patients originally took part. Patients received the selective serotonin reuptake inhibitor (SSRI) antidepressant paroxetine and an augmenting agent (pindolol) or placebo. After 6 weeks, patients were offered SSRI alone on an open label basis for up to 6 months. At that point they were discharged to their general practitioner or local psychiatric services and subsequently assessed by us at one year. We have used techniques of decision analysis, cost effectiveness and cost benefit and have included a sensitivity analysis. The direct costs over one year of SSRI and augmenting agent, if taking the acceleration effect into account, represented greater cost effectiveness than the SSRI antidepressant alone. The cost effectiveness analysis was positive in both cases. We conclude that the direct costs of treatment are higher than those of previous calculated with SSRIs; but the rate of onset must be taken into account. The application of the model appears valid and useful, and may be used as part of the evaluation of other augmentation regimes.

Cost-Benefit Analysis↗

Serotonergic autoreceptor blockade in the reduction of antidepressant latency: personality variables and response to paroxetine and pindolol.

No antidepressant currently in use exerts a significant antidepressant effect for at least two to three weeks after the patient starts taking it. Open studies suggest that, for selective serotonergic re-uptake inhibitor (SSRI) antidepressants, this latency may be reduced when the drug is taken with the 5HT1A receptor blocker pindolol. We have undertaken a randomised, placebo controlled, double blind trial of augmentation of the selective SSRI antidepressant paroxetine in combination with pindolol. All our patients (n = 54; mean age 36 [range 19-65]) met criteria for major depression and received a standard dose (20 mg o.d.) of paroxetine plus, randomly, either pindolol (2.5 mg t.d.s.) or placebo for six weeks. We examined personality variables in 48 consecutive subjects according to a short version (TCI-125) of Cloninger et al's self-rated Temperament and Character Inventory (Cloninger et al., 1994) and correlated the results with clinical responses in the trial. The results suggest that personality can influence clinical outcome. After the double blind period patients were offered paroxetine 20 mg or 40 mg for up to 6 months. Twenty-six patients took this up. The results suggest that high scores in the temperament dimension of Reward Dependence and low scores in the temperament dimension of Harm Avoidance had a better outcome at 6 weeks. Patients who had received paroxetine and pindolol during the trial and who reported high Novelty Seeking and low Harm Avoidance scores had a better outcome at 6 weeks and 6 months. We suggest that temperament factors may influence outcome of antidepressant treatment.

Adrenergic beta-Agonists↗

Cost-benefit & cost-effectiveness analysis of the rapid onset of selective serotonin reuptake inhibitors by augmentation.

OBJECTIVE: This article describes a method for evaluating the value of the increased cost of pharmacologic augmentation of an antidepressant. METHOD: Data to illustrate the method and interpretation of results were derived from a randomized, placebo controlled double blind trial. Eighty outpatients meeting ICD-10 criteria for depressive disorder and scoring > 18 on the Montgomery Asberg Depression Rating Scale (MADRS) were recruited from a primary care population. All patients received SSRI antidepressant and either "augmenting agent" or placebo. The trial period was six weeks, during which the patients were monitored for changes in depressive symptoms using the MADRS. The economic analysis is based only on direct costs of treatment. The analytic approach includes decision analysis, cost-effectiveness and cost-benefit techniques, and a sensitivity analysis. RESULTS: The economic analysis was performed on both the intention-to-treat and per-protocol population. Intention-to-treat and per-protocol results show that the direct cost of six weeks' treatment with the combination of "augmenting agent" and SSRI antidepressant, if the acceleration effect is taken into account, was more cost effective than the SSRI antidepressant and placebo. CONCLUSION: The direct costs of treatment are higher than those of previous pharmaco-economic studies, but the rate of onset of antidepressant action must be taken into account. The application of the evaluative model appears valid and useful. The model is pragmatic and should be expanded for generalizability.

Antidepressive Agents↗

Paroxetine and pindolol: a randomized trial of serotonergic autoreceptor blockade in the reduction of antidepressant latency.

A double-blind, randomized, placebo-controlled, parallel group study was performed in 80 adult outpatients meeting ICD-10 criteria for major depression and with a Montgomery-Asberg Depression Rating Scale (MADRS) score of at least 18 at baseline. All patients received paroxetine (20 mg once a day) plus either pindolol (2.5 mg three times a day) or matching placebo for 6 weeks. Analysis of the day 14 MADRS scores on an intent-to-treat basis revealed a treatment-by-centre interaction, with a significant effect of pindolol being demonstrable at only one centre. At this centre, 25% of the paroxetine plus pindolol group and 0% of the paroxetine plus placebo group showed a decrease of at least 50% from baseline MADRS by day 4 (p < 0.05). At day 14, the proportions were 73% and 7%, respectively (p < 0.001). Analysis of covariance on a "perprotocol" population demonstrated a significant accelerator effect of pindolol at days 4 and 7 in the absence of a treatment-by-centre interaction, but a centre effect was apparent at later time-points. The results suggest that the latency of antidepressant action can be reduced with pindolol augmentation. A large multicentre study is in progress to investigate this effect further.

Adrenergic beta-Antagonists↗

Male genital self-mutilation.

Male genital self-mutilation is a phenomenon which transcends nosological boundaries. This article reviews 98 cases reported in the English language literature. We note that outcome is often better than is assumed. We emphasize the importance of close liaison between the psychiatric and surgical team in managing these patients.

Adult↗