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Marplan (Isocarboxazid) - Summary

 
 



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)
brand of isocarboxazid
tablets

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.


See all Marplan indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Marplan (Isocarboxazid)

Late Depression May Portend Dementia (CME/CE)
Source: MedPage Today Cardiology [2017.05.18]
(MedPage Today) -- Stronger relationship between depression, dementia with shorter timeline

Hypothesis Busted: Depression Not a Risk Factor for Dementia
Source: Medscape Psychiatry & Mental Health Headlines [2017.05.17]
A 28-year follow-up study shows there's no support for the hypothesis that depressive symptoms increase dementia risk.
Medscape Medical News

First-Ever Guideline for Mixed Depression Released
Source: Medscape Psychiatry & Mental Health Headlines [2017.05.16]
Depression with mixed features may be better treated with an antipsychotic than an antidepressant, says the first-ever guideline on recognizing and treating mixed depression.
Medscape Medical News

FDA Data Support Ketamine as Depression Therapy
Source: MedPage Today Psychiatry [2017.05.12]
(MedPage Today) -- Analysis of FAERS data finds less comorbid depression among pain patients on ketamine

Depression's Gender Gap Shows Up in Pre-Teen Years
Source: MedicineNet Teenagers Specialty [2017.05.03]
Title: Depression's Gender Gap Shows Up in Pre-Teen Years
Category: Health News
Created: 5/2/2017 12:00:00 AM
Last Editorial Review: 5/3/2017 12:00:00 AM

more news >>

Published Studies Related to Marplan (Isocarboxazid)

Moclobemide in depression: a randomized, multicentre trial against isocarboxazide and clomipramine emphasizing atypical depression. [1991.12]
Moclobemide was compared with isocarboxazide and clomipramine in patients with depression. A total of 167 outpatients were allocated to daily treatment with 300 mg moclobemide, 30 mg isocarboxazide or 150 mg clomipramine for 6 weeks... Anticholinergic symptoms and orthostatic hypotension were most pronounced in the clomipramine group.

A trial of isocarboxazid in the treatment of bulimia nervosa. [1988.12]
Eighteen women completed a double-blind, placebo-controlled crossover study designed to investigate the effects of isocarboxazid in the treatment of bulimia nervosa. There was a significant reduction in binge eating and vomiting during isocarboxazid treatment... There were no serious adverse effects from this monoamine oxidase inhibitor therapy, although over 50% of patients elected to discontinue isocarboxazid 1 year after the study.

An efficacy study of isocarboxazid and placebo in depression, and its relationship to depressive nosology. [1988.02]
Isocarboxazid and placebo were evaluated in 130 anxious depressives. Drug was superior to placebo on depression, anxiety, interpersonal sensitivity, and global measures, and on symptoms of hostility, anxiety, obsessiveness, and psychological-cognitive components of depression...

[Prolonged hyperthermia after isocarboxazid poisoning] [2003.04.28]
A 44-year-old unconscious man was admitted 24 hours after intake of approximately one gram of isocarboxazid. He was subsequently intubated for seven days... Massive rhabdomyolysis was treated with forced diuresis.

Disruption of FR-40 by 5-HT agonists. II. Effects of chronic phenelzine or isocarboxazid. [1989.10]
Effects of chronic treatment with the monoamine oxidase inhibitors phenelzine and isocarboxazid on disruption of FR-40 operant responses by 5-HT agonists have been studied. Three groups of rats that were trained in the FR-40 operant schedule showed marked disruption by 0.1 mg/kg IP lysergic acid diethylamide (LSD), 2 mg/kg IP quipazine (Q), 0.05 mg/kg SC 8-hydroxy-2-(di-n-propylamino)tetralin (8-OHDPAT), and 1 mg/kg SC (m-trifluoromethyl-phenyl)piperazine (TFMPP), administered twice weekly in random order...

more studies >>

Clinical Trials Related to Marplan (Isocarboxazid)

I2PETHV - Imidazoline2 Binding Site in Healthy Volunteers [Recruiting]
The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric conditions such as depression and addiction, along with neurodegenerative disorders such as Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated functional interactions with the opioid system, where I2BS ligands have been shown to affect tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats. Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic effects in different models of pain and a novel I2BS ligand, CR4056, is currently undergoing Phase II clinical trials as a novel treatment for neuropathic pain and acute non- specific pain states. The location of I2BS on astrocytic glial cells and the possibility that they may in some way regulate glial fibrillary acidic protein have led to increased interest into the role of I2BS and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has been shown to increase in Alzheimer's disease post mortem, and it has also been suggested that I2BS may be a marker for the severity and malignancy of human glioblastomas. The lack of suitable imaging tools for the I2BS has meant that information regarding the number and distribution of I2BS in the brain has come from preclinical species and in vitro post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional distribution in the living human brain. In this study the investigators plan to utilise [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo using PET.

Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism [Completed]
Reduction of volume of the hippocampus has been associated with major depression in many studies. It has been suggested that antidepressants may protect against hippocampus volume loss in humans associated with multiple episodes of depression and may also reverse the reduction of volume caused by the depression. In addition, genetic markers for serotonin are implicated with depression, and may be an indication of reduced response to antidepressant treatments. This study aims to enroll patients who are defined as having treatment resistant depression (no remission after at least 2 treatments trials with an antidepressant). They will receive an MRI scan at the initial visit and either 6 months after sustained remission or 12 months after they enter the study for non-remitters. They will also be asked to give a blood sample for genotyping. They will be matched by age and handedness to healthy volunteers with no personal history of depression who will also receive an MRI scan and genotyping. The first aim is to compare hippocampal volume of depressed subjects to healthy controls. It is anticipated that subjects will initially have smaller hippocampal volume but of those who sustain remission, there will be a small increase in hippocampal volume. It is also anticipated that specific genetic markers will be related to individuals response to antidepressant treatments.

more trials >>


Page last updated: 2017-05-18

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