Safety and Efficacy During Long-Term Treatment with Moclobemide

Moll, Etelka; Neumann, N.-U.; Schmid-Burgk, W.; Stabl, M.; Amrein, R.

doi:10.1097/00002826-199417001-00009

Cited by 30 publications

(19 citation statements)

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“…moclobemide is the maximum tolerated multiple-dose regimen in healthy subjects, at least when no dose titration is applied. Most adverse events reported in this study, in particular headache, dry mouth, and insomnia, have also been observed in patient studies (Moll et al 1994;Hilton et al 1995). The incidence of insomnia, dry mouth and dizziness showed a doseresponse relationship whereas fatigue, lethargy and headache showed a similar overall incidence in all three treatment groups.…”

Section: Discussionsupporting

confidence: 80%

“…Only dizziness, nausea and insomnia / sleep disturbance were slightly but signiÞcantly more frequently reported with moclobemide than with placebo. The drug is as well tolerated in elderly as in young patients after either short-or long-term treatment (Moll et al 1994;Roth et al 1996;Amrein et al 1997). Moclobemide potentiates the e¤ects of orally administered tyramine only approximately 3-to 4-fold, which is not considered clinically signiÞcant (Korn et al 1988).…”

Section: Introductionmentioning

confidence: 99%

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Clinical pharmacology of moclobemide during chronic administration of high doses to healthy subjects

et al. 1998

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The objectives of this study were to assess the tolerability, safety, pharmacodynamics and pharmacokinetics of high-dose moclobemide in healthy subjects. Two sequential groups of six male and six female subjects (eight on active treatment, four on placebo) received for 8 days moclobemide 450 mg b.i.d. and 600 mg b.i.d., respectively. Intravenous tyramine pressor tests were conducted at baseline, at the beginning of treatment and at steady state. Oral tyramine pressor tests with 50, 100 and 150 mg tyramine were conducted under steady-state conditions. Pharmacokinetic parameters of moclobemide and two of its metabolites in plasma and urine were determined after the first and last dose of moclobemide. The incidence and intensity of adverse events was dose-dependent. The most frequently reported adverse events were insomnia, headache, dizziness and dry mouth. The i.v. tyramine pressor sensitivity during both moclobemide dosing regimens was enhanced 3 to 4-fold. Intake of tyramine 50 mg did not result in systolic blood pressure increases greater than 30 mmHg. With regard to blood pressure increases, tyramine 100 mg is still compatible with moclobemide 450 mg b.i.d. but not with 600 mg b.i.d. The clearance of moclobemide decreased by about 60% on multiple dosing, but no differences were found between both dosing regimens. The urinary excretion of the N-oxide metabolite doubled during multiple dosing. In conclusion, the maximum tolerated dose of moclobemide in healthy subjects is 600 mg b.i.d. provided the tyramine content in a meal is not higher than 50 mg.

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Section: Discussionsupporting

confidence: 80%

Section: Introductionmentioning

confidence: 99%

Clinical pharmacology of moclobemide during chronic administration of high doses to healthy subjects

et al. 1998

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“…The authors reported recurrence rates of 25, 14.8, and 12.2% for the first, second and third six-month periods of maintenance treatment, respectively (164). Although of limited value due to the lack of controlled conditions, these rates of recurrence are comparable to those reported for other antidepressants (121).…”

Section: Maintenance Treatmentmentioning

confidence: 76%

Moclobemide: Therapeutic Use and Clinical Studies

Bonnet¹

2003

CNS Drug Reviews

201

100

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Moclobemide is a reversible inhibitor of monoamine-oxidase-A (RIMA) and has been extensively evaluated in the treatment of a wide spectrum of depressive disorders and less extensively studied in anxiety disorders. Nearly all meta-analyses and most comparative studies indicated that in the acute management of depression this drug is more efficacious than placebo and as efficacious as tricyclic (or some heterocyclic) antidepressants or selective serotonin reuptake inhibitors (SSRIs). There is a growing evidence that moclobemide is not inferior to other antidepressants in the treatment of subtypes of depression, such as dysthymia, endogenous (unipolar and bipolar), reactive, atypical, agitated, and retarded depression as with other antidepressants limited evidence suggests that moclobemide has consistent long-term efficacy. However, more controlled studies addressing this issue are needed. For patients with bipolar depression the risk of developing mania seems to be not higher with moclobemide than with other antidepressants. The effective therapeutic dose range for moclobemide in most acute phase trials was 300 to 600 mg, divided in 2 to 3 doses. While one controlled trial and one long-term open-label study found moclobemide to be efficacious in social phobia, three controlled trials subsequently revealed either no effect or less robust effects with the tendency of higher doses (600 -900 mg /d) to be more efficacious. Two comparative trials demonstrated moclobemide to be as efficacious as fluoxetine or clomipramine in patients suffering from panic disorder. Placebocontrolled trials in this indication are, however, still lacking.A relationship between the plasma concentration of moclobemide and its therapeutic efficacy is not apparent but a positive correlation with adverse events has been found. Dizziness, nausea and insomnia occurred more frequently on moclobemide than on placebo. Due to negligible anticholinergic and antihistaminic actions, moclobemide has been better tolerated than tri-or heterocyclic antidepressants. Gastrointestinal side effects and, espe-97

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“…Specifically, in analyses of large prospective studies containing over 20,000 patients (Coulter and Pillans, 1995;Delini-Stula et al, 1999), the risk of hypertension or hypotension with moclobemide was estimated at 0.11 and 0.04-0.05%, respectively. In addition, moclobemide was not found to result in changes in supine or standing blood pressure in one study, while in patients with pre-existing hypertension, no significant increases beyond baseline values occurred (Moll et al, 1994). Salt tablets may be useful in alleviating MAOI-emergent postural hypotension (Munjack, 1984).…”

Section: Side-effect Profilementioning

confidence: 99%

Monoaminergic‐based Pharmacotherapy for Depression

Papakostas¹,

Fava²

2005

Biology of Depression

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Although recent advances in neuropharmacology, neuroendocrinology, molecular biology, and pharmacogenetics have been instrumental in bringing about potential treatments for depression which are fundamentally unrelated to their predecessors, including substance P antagonists, glutaminergic agents, and corticotropinreleasing factor (CRF) antagonists, nevertheless it was agents that influenced the function of monoamine receptors and transporters that were discovered initially by serendipity and then developed as treatments for depression. The development of such compounds also served as a framework for the understanding of depression as a medical illness affecting brain functioning. As a result of these efforts, our field has gained further understanding of the role of monoamines in depression. In previous chapters, the relevance of monoamines in the underlying pathophysiology of depression was reviewed. In the following chapter we will focus on describing the contemporary role of monoaminergic agents in the treatment of depression. 6.

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Safety and Efficacy During Long-Term Treatment with Moclobemide

Cited by 30 publications

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Clinical pharmacology of moclobemide during chronic administration of high doses to healthy subjects

Clinical pharmacology of moclobemide during chronic administration of high doses to healthy subjects

Moclobemide: Therapeutic Use and Clinical Studies

Monoaminergic‐based Pharmacotherapy for Depression

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