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Marplan (Isocarboxazid) - Summary

 

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Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Marplan or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Marplan is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

 

MARPLAN SUMMARY

Marplan (isocarboxazid), a monoamine oxidase inhibitor, is available for oral administration in 10-mg tablets.

Marplan is indicated for the treatment of depression. Because of its potentially serious side effects, Marplan is not an antidepressant of first choice in the treatment of newly diagnosed depressed patients.

The efficacy of Marplan in the treatment of depression was established in 6-week controlled trials of depressed outpatients. These patients had symptoms that corresponded to the DSM-IV category of major depressive disorder; however, they often also had signs and symptoms of anxiety (anxious mood, panic, and/or phobic symptoms) (See CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The antidepressant effectiveness of Marplan in hospitalized depressed patients, or in endogenomorphically retarded and delusionally depressed patients, has not been adequately studied.

The effectiveness of Marplan in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Marplan for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient.

MARPLAN NEWS HIGHLIGHTS

Media Articles Related to Marplan (Isocarboxazid)

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Source: Depression News From Medical News Today [2008.09.04]

BioMedEcon Reports Six Times Higher Psychiatric Medication Costs Among Patients With OCD Compared To Patients With Depression
Source: Psychology / Psychiatry News From Medical News Today [2008.09.04]

Inflammatory bowel disease linked to depression (Reuters)
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Singulair not linked to suicide, depression (Reuters)
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3 Questions Can Spot Possible Postpartum Depression
Source: MedicineNet Depression Specialty [2008.09.03]

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Published Studies Related to Marplan (Isocarboxazid)

Moclobemide in depression: a randomized, multicentre trial against isocarboxazide and clomipramine emphasizing atypical depression. [1991.12]

A trial of isocarboxazid in the treatment of bulimia nervosa. [1988.12]

An efficacy study of isocarboxazid and placebo in depression, and its relationship to depressive nosology. [1988.02]

[Prolonged hyperthermia after isocarboxazid poisoning] [2003.04.28]

Disruption of FR-40 by 5-HT agonists. II. Effects of chronic phenelzine or isocarboxazid. [1989.10]

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Clinical Trials Related to Marplan (Isocarboxazid)

Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism [Recruiting]

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Page last updated: 2008-09-04

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