Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0011570 (depression)
 172,036 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Patients (n = 150) were randomized to a 6-week, double-blind study to evaluate the relative efficacy and safety of mirtazapine, amitriptyline, and placebo in the treatment of major depressive disorder symptoms. Average daily modal doses were mirtazapine, 18 mg; amitriptyline, 111 mg; and placebo, 4.6 capsules. Mirtazapine- and amitriptyline-treated patients had statistically significantly greater mean Hamilton Rating Scale for Depression (HAM-D) score reductions (weekly visits 1, 2, 4, and endpoint) compared to placebo. These findings were supported by the Montgomery-Asberg Depression Rating Scale (MADRS); the Zung Self-rating Depression Scale (SDS); and the Clinical Global Impressions (CGI) scales. Somnolence and weight gain were the only adverse clinical experiences (ACEs) reported substantially more often by mirtazapine-treated patients than by those in the placebo group. However, more amitriptyline-treated patients reported decreased visual accommodation, dry mouth, dyspepsia, constipation, tachycardia, hypertension, hypotension, discoordination, dizziness, and tremor than mirtazapine- or placebo-treated patients. Results of this study indicate that mirtazapine is more effective than placebo in the treatment of these patients, and superior to amitriptyline in respect to anticholinergic and cardiovascular effects.
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PMID:Mirtazapine vs. amitriptyline vs. placebo in the treatment of major depressive disorder. 223 55

Two hundred hospitalized patients with DSM-III diagnosis of moderate to severe major depressive episode were randomized to receive mirtazapine or trazodone for 6 weeks in a double-blind trial. The dosages were 24-72 mg/day for mirtazapine and 150-450 mg/day for trazodone. The improvement on all depression rating scales used was generally greater for mirtazapine, with statistically significant differences over trazodone in the Hamilton Psychiatric Rating Scale for Depression total score and two subscores (the Bech melancholia factor and retardation factor), the Brief Psychiatric Rating Scale total score, the General Psychiatric Impression Global Assessment Scale, the Beck score and responder rates. Mirtazapine was well tolerated, while the trazodone-treated patients experienced somnolence more frequently, particularly during the first 2 weeks of treatment. Furthermore, postural symptoms were a clinical problem in 6% of the trazodone-treated patients. In this trial, mirtazapine showed significant clinical advantages over trazodone in terms of overall efficacy and tolerability.
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PMID:Mirtazapine is more effective than trazodone: a double-blind controlled study in hospitalized patients with major depression. 762 1

Mirtazapine is a novel antidepressant with a unique mode of action, which can be best summarized as a noradrenaline and specific serotonin antidepressant. Its unique mode of action, involving both the noradrenergic and serotonergic neurotransmitter systems, results in strong clinical efficacy. A comprehensive clinical trial programme in Europe and the United States has demonstrated that mirtazapine has clear clinical benefits in a broad range of patients treated across different therapeutic settings. The individual placebo-controlled trials and a meta-analysis on pooled efficacy data from all available placebo-controlled studies have shown that mirtazapine has sustained antidepressant efficacy, as assessed by changes from baseline in group mean scores on the Hamilton Rating Scale for Depression (HAMD) and in the depressed mood item, from week 1 throughout the whole study period. Corroborative evidence on the clinical efficacy of mirtazapine has been obtained in comparative studies with antidepressant drugs of well established efficacy, such as amitriptyline, clomipramine, doxepin and trazodone. As with the placebo-controlled studies, a meta-analysis was performed on data from all the randomized, double-blind, comparative studies of mirtazapine and amitriptyline. Data from 732 patients were available (364 patients taking mirtazapine and 368 taking amitriptyline) for efficacy analysis. Equivalent improvements in total 17-item HAMD scores from baseline were observed in both treatment groups at all scheduled assessments and at the end of the study period, and similarly high percentages of patients responded to treatment with either mirtazapine (70%) or amitriptyline (73%). The efficacy of mirtazapine was also assessed in the treatment of moderately (baseline 17-item HAMD score 18-24) or severely depressed patients (baseline 17-item HAMD score > or = 25). A meta-analysis was performed on the pooled data from the moderately or severely depressed patients in the comparative studies of mirtazapine and placebo or mirtazapine and amitriptyline. Statistically and clinically significant improvements from baseline were seen in both moderately and severely depressed patients treated with mirtazapine compared with placebo, while an equivalent extent of improvement was present with mirtazapine and amitriptyline. A similar pattern was observed in the improvement of depressed mood (HAMD item 1) and other clinically important symptoms of depression: mirtazapine was significantly more efficacious than placebo, and of equivalent efficacy to amitriptyline. Therefore, it can be concluded that the new antidepressant mirtazapine offers distinct therapeutic benefits for a variety of depressed patients in either in- or outpatient settings.
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PMID:Clinical efficacy of mirtazapine: a review of meta-analyses of pooled data. 893 7

The effectiveness of the newer antidepressants in comparison to that of the more established agents is frequently questioned. Although selective serotonin reuptake inhibitors (SSRIs) show a high degree of pharmacologic selectivity, this does not seem to translate into improved clinical efficacy. Instead, the clinical effectiveness of the tricyclic agents may be attributable to their dual inhibitory effects on both noradrenergic and serotonergic systems. Accordingly, newer antidepressants with multiple modes of action may prove more effective than serotonin-selective compounds. To assess the relative merits of older and newer antidepressant drugs in severe depression, efficacy findings from the limited number of comparative clinical trials conducted in this patient population were reviewed. A systematic approach was taken, with studies being grouped according to the various characteristics that, in conjunction with standard DSM-IV and International Classification of Diseases, 10th revision, diagnostic criteria, define severe depression, viz. a 17-item Hamilton Rating Scale for Depression score > or = 25, hospitalization, and the presence of psychotic (delusional), melancholic, and endogenous features. The contention that tricyclic antidepressants offer superior efficacy to the SSRIs and the reversible monoamine oxidase inhibitors in the treatment of severe depression is supported by several comparisons of clomipramine with fluoxetine, paroxetine, citalopram, and moclobemide. Venlafaxine also seems to be more effective than fluoxetine in hospitalized patients with melancholic depression. Mirtazapine, a noradrenergic and specific serotonergic antidepressant, displays comparable antidepressant efficacy to clomipramine and amitriptyline in severe depression and seems to be a useful option in this patient population.
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PMID:Efficacy of antidepressants in the treatment of severe depression: the place of mirtazapine. 909 May 74

Mirtazapine is the first of a new class of antidepressants, the noradrenergic and specific serotonergic antidepressants (NaSSA). Its antidepressant effect appears to be related to its dual enhancement of central noradrenergic and serotonin 5-HT1 receptor-mediated serotonergic neurotransmission. Mirtazapine possesses a number of useful pharmacokinetic characteristics such as good absorption, linear pharmacokinetics over the recommended dosage range (15 to 80 mg/day), and an elimination half-life of 20 to 40 hours, thereby allowing once-daily administration. However, since the drug is extensively metabolised by the hepatic cytochrome P450 (CYP) system and is excreted mainly in the urine, its clearance may be reduced by hepatic or renal impairment. In vitro data suggest that from a clinical point of view it is unlikely that mirtazapine would inhibit the metabolism of coadministered drugs metabolised by CYP1A2, CYP2D6 or CYP3A4. In vivo data from a study in extensive and poor metabolisers of debrisoquine indicate that strong inhibitors of CYP2D6 would have no effect on the concentration of racemic mirtazapine. In some placebo-controlled studies mirtazapine showed an early onset of antidepressant action, with significant reductions in total Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale scores (relative to placebo) noted as early as 1 week after starting treatment. This therapeutic advantage was subsequently maintained during treatment, with mirtazapine proving significantly superior to placebo at treatment end-point in the majority of studies. In comparative trials, the antidepressant efficacy of mirtazapine was comparable with that of tricyclic antidepressants such as amitriptyline, clomipramine and doxepin, and in 2 studies superior to that of trazodone and fluoxetine. Mirtazapine appears to have a broad spectrum of activity, reflected in its efficacy in a variety of clinical settings. Its additional beneficial effects on the symptoms of anxiety and sleep disturbance associated with depression may reduce the need for concomitant anxiolytic and hypnotic medication seen with some antidepressants. Mirtazapine has demonstrated superior tolerability to the tricyclic antidepressants and trazodone, primarily on account of its relative absence of anticholinergic, adrenergic and serotonin-related adverse effects, in particular gastrointestinal adverse effects and sexual dysfunction. It appears that increased sedation associated with the drug is related to subtherapeutic dosages, and that it is reported in substantially fewer patients when the drug is used in appropriate dosages (> or = 15 mg as a single evening dose) from the beginning of treatment. Although 2 cases of reversible severe symptomatic neutropenia have been reported in clinical trials, there have been no additional reports of symptomatic neutropenia since the introduction of this drug to various countries in September 1994. Currently available data and initial clinical experience suggest that with its combination of dual action, simple pharmacokinetics, and clinical efficacy and tolerability, mirtazapine appears to be an important advance in the pharmacotherapy of depression.
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PMID:A risk-benefit assessment of mirtazapine in the treatment of depression. 935 61

The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of mirtazapine are reviewed. Mirtazapine is a new anti-depressant that blocks presynaptic alpha 2-adrenergic receptors and postsynaptic serotonin type 2 and type 3 receptors. Mirtazapine has FDA-approved labeling for treatment of depression. Limited data suggest it may also have beneficial anxiolytic and sedative effects. The drug is rapidly and completely absorbed after oral administration. It is biotransformed by hepatic demethylation and is suitable for once-daily doses. In several clinical trials, patients receiving mirtazapine showed significantly greater improvement as measured by scores on the Hamilton Rating Scale for Depression (HAM-D) compared with patients receiving placebo. Mirtazapine has been shown to be equally efficacious as amitriptyline, clomipramine, and doxepin as assessed by scores on the HAM-D or other depression rating scales. Mirtazapine is well tolerated. The most commonly reported adverse effects associated with mirtazapine are somnolence, increased appetite, weight gain, and dizziness. Few drug-drug interactions have been reported. The recommended starting dosage is 15 mg/day administered in a single dose at bedtime. Mirtazapine seems to be an effective, well-tolerated antidepressant and may be effective for treating comorbid anxiety disorders.
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PMID:Mirtazapine, an antidepressant. 943 74

Of 580 patients randomly assigned to short-term, double-blind treatment with either mirtazapine, amitriptyline or placebo, a total of 217 patients clinically judged to be responders subsequently continued on the same medication for up to 2 years in the long-term treatment study (mirtazapine, n = 74; amitriptyline, n = 86 and placebo, n = 57). The efficacy of mirtazapine in relapse prevention was seen in an analysis of the first 20 weeks data. Significantly fewer patients relapsed during treatment with mirtazapine compared with placebo (p < 0.05), and a significantly longer time to relapse was shown on the survival analysis. There was a significant advantage for amitriptyline compared with placebo in the first 20 weeks, with fewer patients relapsing. There was a significant advantage for mirtazapine compared with amitriptyline at 20 weeks seen on the survival analysis (p < 0.05). The significant advantage for mirtazapine compared with placebo was also seen in the prophylactic phase of treatment after 20 weeks. At the endpoint there were significantly more patients in the placebo group with a return of symptoms and significantly fewer showing sustained response. Amitriptyline was better than placebo with fewer patients suffering a recurrence of symptoms, but there was no difference from placebo in the proportion of patients with sustained response. Mirtazapine was well tolerated with a side-effect profile similar to that of placebo. The only adverse event reported significantly more frequently on mirtazapine than on placebo was weight gain. Objectively measured weight gain was more frequent with amitriptyline (22% of patients) compared with mirtazapine (13% of patients). Amitriptyline was associated with significantly more adverse events than either mirtazapine or placebo, in particular sedative and anticholinergic side effects. The efficacy of mirtazapine in reducing the risk of relapse and the recurrence of depression, which on some measures showed an advantage compared with amitriptyline, coupled with its improved side-effect profile, commends this antidepressant for the long-term treatment of depression.
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PMID:Mirtazapine versus amitriptyline in the long-term treatment of depression: a double-blind placebo-controlled study. 966 86

Mirtazapine is a new antidepressant with a specific pharmacological profile which is different from all other currently available antidepressants. It is a so-called noradrenergic and specific serotonergic antidepressant (NaSSA). 46 in-patients were treated with mirtazapine. The mean dose was 56 mg mirtazapine per day (SD: 23; range: 15 to 90). The duration of treatment was 3.6 weeks (SD +/- 3.4). Patients presented with following diagnosis: 29 (= 63%) were diagnosed as having a unipolar depression, 26% (n = 12) suffered from a depression in the course of a bipolar disorder. 37% (n = 17) were moderately depressed, 52% (n = 24) were severely depressed. 2 patients (= 4%) met ICD-10 (international Classification of Diseases) criteria for a schizoaffective disorder, 2 patients (= 4%) suffered from dysthymia. 1 patient suffered from an organic depressive disorder. The efficacy of the treatment was evaluated with CGI (Clinical Global Impression), when patients were discharged from hospital. 68% of the patients were in partial or full remission (CGI 2, 3 and 4), 17% were unimproved (CGI 5 and 6), in 15% of the patients the treatment was stopped before. Our observations are indicative that mirtazapine is effective in the treatment of moderately and severely depressed patients and therefore confirm the data obtained in phase III-trials. Furthermore we found mirtazapine in either mono- or combination-therapy with various other antidepressants to be tolerated well. Side effects did not cause in a single patient a discontinuation in treatment.
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PMID:[Mirtazapine in inpatient treatment of depressed patients]. 981 38

Mirtazapine is a newer antidepressant that exhibits both noradrenergic and serotonergic activity. It is at least as effective as the older antidepressants for treating mild to severe depression. Sedation is the most common side effect. Although agranulocytosis is the most serious side effect, it is rare (approximately one in 1,000) and usually reversible when the medication is stopped. Mirtazapine is relatively safe in overdose. Many clinicians consider mirtazapine a second-line or even third-line antidepressant to be used when older antidepressants are not tolerated or are ineffective. Physicians who are concerned about the risks of elevated lipid levels and agranulocytosis may choose to reserve mirtazapine as a third-line choice. It is particularly useful in patients who experience sexual side effects from other antidepressants. Mirtazapine is also a good choice in depressed patients with significant anxiety or insomnia. Although mirtazapine has been used successfully in Europe for a number of years, its place in the care of patients with depression in the United States has not yet been established.
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PMID:Mirtazapine: a newer antidepressant. 1050 41

Recurrent brief depression (RBD) has a high prevalence in the general population (approximately 10%). At present, data on the treatment of RBD are sparse. Results of treatment studies with selective serotonin reuptake inhibitors (fluoxetine, paroxetine) did not demonstrate superiority of the active drug over placebo in RBD. We report about two patients with RBD treated with mirtazapine over a period of 4 months. Mirtazapine is a noradrenergic with specific selective serotoninergic antidepressant. Patients had to keep a diary in order to document psychopathological symptoms of major depression according to DSM-IV. We showed a marked reduction of severity, duration and frequency of brief depressive episodes in two patients with RBD treated with 30 mg mirtazapine over a period of 4 months. Mirtazapine enhances serotonergic as well as noradrenergic neurotransmission. This dual mechanism of action may be necessary to improve RBD. Consequently, mirtazapine might be a treatment option for patients with RBD. However, our preliminary observations need to be substantiated in controlled studies.
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PMID:Mirtazapine in recurrent brief depression. 998 66


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