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Remeron (Mirtazapine) - 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 of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of REMERON® (mirtazapine) Tablets 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. REMERON® is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)

 

REMERON SUMMARY

REMERON® (mirtazapine) Tablets are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c] benzazepine and has the empirical formula of C17H19N3.

REMERON® (mirtazapine) Tablets are indicated for the treatment of major depressive disorder.

The efficacy of REMERON® in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder (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, a suicide attempt or suicidal ideation.

The effectiveness of REMERON® in hospitalized depressed patients has not been adequately studied.

The efficacy of REMERON® in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8–12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use REMERON® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).


See all Remeron indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Remeron (Mirtazapine)

Behavior Therapy May Help Prevent Depression Over Vision Loss
Source: Medscape Ophthalmology Headlines [2014.07.25]
For older people with central vision loss, combining occupational therapy with behavior therapy to keep them from becoming too isolated may prevent depression, according to a new study.
Reuters Health Information

Severe pain during and post delivery linked to postpartum depression
Source: Depression News From Medical News Today [2014.07.25]
Controlling pain during childbirth and post delivery may reduce the risk of postpartum depression, writes Katherine Wisner, M.D.

Low field magnetic stimulation may be an effective treatment for depression
Source: Bipolar News From Medical News Today [2014.07.24]
Brain stimulation treatments, like electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS), are often effective for the treatment of depression.

Doctors achieve performance improvement in management of depression
Source: Compliance News From Medical News Today [2014.07.23]
A performance improvement initiative for physicians can significantly increase their use of evidence-based practices in screening for and treating depression, in the July Journal of Psychiatric...

Attenuated inhibition of neuron membrane excitability contributes to childhood depression
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2014.07.21]
Accumulating evidence suggests that the nucleus accumbens, which is involved in mechanisms of reward and addiction, plays a role in the pathogenesis of depression and in the action of antidepressants.

more news >>

Published Studies Related to Remeron (Mirtazapine)

Mirtazapine to reduce methamphetamine use: a randomized controlled trial. [2011.11]
CONTEXT: No approved pharmacologic treatments for methamphetamine dependence exist. Methamphetamine use is associated with high morbidity and is a major cofactor in the human immunodeficiency virus epidemic among men who have sex with men (MSM). OBJECTIVE: To determine whether mirtazapine would reduce methamphetamine use among MSM who are actively using methamphetamine... CONCLUSION: The addition of mirtazapine to substance use counseling decreased methamphetamine use among active users and was associated with decreases in sexual risk despite low to moderate medication adherence. Trial Registration clinicalTrials.gov Identifier NCT00497081.

Adjunct mirtazapine for negative symptoms of schizophrenia. [2011.10]
Negative symptoms of schizophrenia are characterized by affective flattening, alogia, avolition, and anhedonia and are often nonresponsive to antipsychotic therapy. Because negative symptoms are predictive of poor occupational and social functioning, as well as poor global outcomes, numerous studies evaluating adjunct therapy to antipsychotics have been conducted...

Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial. [2011.07.30]
BACKGROUND: Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo... INTERPRETATION: Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer's disease should be reconsidered. FUNDING: UK National Institute of Health Research HTA Programme. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

More evidence on proneurocognitive effects of add-on mirtazapine in schizophrenia. [2011.06.01]
Enhancement of neurocognition is essential in the treatment of schizophrenia. In our previously reported six-week randomized controlled trial (RCT) mirtazapine added to conventional antipsychotics improved not only negative, but also positive symptoms and neurocognition in difficult-to-treat schizophrenia...

Residual effects of esmirtazapine on actual driving performance: overall findings and an exploratory analysis into the role of CYP2D6 phenotype. [2011.05]
INTRODUCTION: Esmirtazapine is evaluated as a novel drug for treatment of insomnia. PURPOSE: The present study was designed to assess residual effects of single and repeated doses of esmirtazapine 1.5 and 4.5 mg on actual driving in 32 healthy volunteers in a double-blind, placebo-controlled study. Treatment with single doses of zopiclone 7.5 mg was included as active control... CONCLUSION: It is concluded that single and repeated doses of 1.5 mg esmirtazapine are generally not associated with residual impairment. Single-dose administration of 4.5 mg esmirtazapine was associated with residual impairment that generally resolved after repeated administration. Exploratory analysis in a small group of poor CYP 2D6 metabolizers suggested that these subjects are more sensitive to the impairing effects of esmirtazapine on car driving.

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Clinical Trials Related to Remeron (Mirtazapine)

Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight [Recruiting]
The purpose of this study is to find out if remeron, also called mirtazapine, can help you prevent weight loss while on treatment for your cancer. Remeron is currently used to treat depression and has not been approved by the Food and Drug Administration for use to treat weight loss.

A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans and Veterans From All Other Southwest Asia Conditions [Recruiting]
The primary objective is to evaluate the efficacy and tolerability of mirtazapine (Remeron) in the treatment of PTSD. Primary Hypothesis to be tested: Veterans with PTSD will have improvement in their symptomatology after 8 weeks of treatment with mirtazapine compared to those treated with placebo. After completion of the placebo-controlled phase, patients who agree to continue in the study will be treated with open-label mirtazapine for an additional 8 weeks.

Study of Indoleamine 2,3-dioxygenase Activity and Mirtazapine Efficacy in Fibromyalgia Syndrome [Recruiting]
This study aims to investigate the anti-nociceptive biogenic amine (serotonin [5-hydroxytryptamine; 5-HT], norepinephrine [NE], dopamine [DA], and their metabolites) status in Thai fibromyalgia syndrome (FMS) patients compared with a representative Thai population. The efficacy and the tolerability of mirtazapine as monotherapy for FMS will also be assessed. In addition, proof of concept of the indoleamine 2,3-dioxygenase (IDO) activity in FMS will be conducted.

The study will be divided into three parts. In part I, FMS patients of Thai ethnicity will be examined to determine the blood and/or urinary level of anti-nociceptive biogenic amines by comparison with the demographically matched, but unrelated, healthy normal controls (HNC). In part II, the FMS subjects from part I study will be randomized to blinded therapy with mirtazapine or identical appearing placebo. There will be three treatment groups (N=1: 1:1) to accommodate two dosages of mirtazapine (15 mg, 30mg) and placebo given before bedtime. Pill counts at baseline and at follow-up visits will document compliance. Standard outcome instruments (translated and validated in Thai language) will be used at baseline and at each of the follow-up visits. The primary outcome variable will be the changes in the pain visual analog scale (PVAS) score. Secondary clinical outcome variables of interest will include depression, insomnia, anxiety, physical function, morning stiffness, patient global assessment of disease status, patient global impression of change, quality of life and adverse experience. The changes of biogenic amine and IGF-1 concentrations in blood and/or urine with the treatment will be examined as the secondary biochemical measures. In part III, the IDO activity of depressed FMS, non-depressed FMS and HNC will be compared. Moreover, the effect of mirtazapine treatment on the IDO activity in depressed and non-depressed FMS patients will be assessed.

Study hypothesis

1. Anti-nociceptive biogenic amine levels in Thai FMS patients are lower than in Thai healthy normal control.

2. Higher IDO activity could be observed in FMS patients.

3. Mirtazapine is effective in FMS treatment.

Evaluation of Mirtazapine and Folic Acid for Schizophrenia: [Recruiting]
Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the effects of adding mirtazapine and folic acid to existing therapy for patients with schizophrenia

Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early Improvement [Recruiting]
Although treatment guidelines manifest that antidepressant response usually appear with a delay of several weeks and suggest that treatment should be changed if a partial response has not occurred after 4~6 week, these beliefs are no longer held by experts, and a new concept is raised that the first 2 weeks of treatment may be a useful strategy for improving the management of depression. New evidence indicates that early treatment response can be predicted with high sensitivity after 2 weeks of treatment in patients with major depressive disorder (MDD).

Because most antidepressant treatment guidelines continue to suggest 4~6 weeks of treatment until nonresponse can be assumed, adherence is required from depressed patients. The ability to identify the early action of antidepressants allows for earlier initiation of a treatment adaptation such as alternative or adjunctive treatment. The early identification of non responders is also important because selection of an antidepressant agent is still primarily guided by trial. Early improvement not only predicted response or remission, but also that lack of improvement was associated with little chance of response if the treatment strategy remained unchanged. Once a patient demonstrates an appropriate response to an antidepressant, ongoing treatment is recommended. The criterion of a 20% score reduction has been chosen as an early indicator of improvement because it can be reliably measured in clinical trials and translates into a clinically relevant change in the severity of depressive symptoms.

Antidepressants that enhance both serotonergic and noradrenergic neurotransmission may be more effective than selective serotonin reuptake inhibitors (SSRIs) for acute-phase therapy of major depressive disorder. As a noradrenergic and specific serotonergic antidepressant, the antidepressive mechanism of mirtazapine is quite superior to SSRI and in particular has been suggested to have a faster onset of action than SSRIs in MDD patients. Mirtazapine has significant advantages in response and remission rates compared with various SSRIs in double-blind treatment. Mirtazapine combined with SSRIs or venlafaxine was also found to be one of the more effective and successful strategy for nonresponders in MDD. The investigators hypothesized that mirtazapine as adjunctive treatment to paroxetine can boost the onset time and also can improve the antidepression action of SSRIs in patients without early improvement.

The aim of this study is to provide physicians with further information regarding early improvement and mirtazapine combined with a SSRI antidepressant therapy in nonresponders, by providing a comparison of depressive symptoms outcomes associated with adjunctive mirtazapine or mono- paroxetine in MDD patients who have previously been treated with paroxetine for 2 weeks and who have not attained improvement. Paroxetine has been chosen as a comparator because it is a widely-used and relatively well-tolerated SSRI antidepressant.

more trials >>

Reports of Suspected Remeron (Mirtazapine) Side Effects

Suicide Attempt (47)Somnolence (30)Multiple Drug Overdose Intentional (30)Agitation (26)Amnesia (25)Overdose (23)Chronic Obstructive Pulmonary Disease (22)Emphysema (21)Bedridden (20)Completed Suicide (20)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 9 ratings/reviews, Remeron has an overall score of 6.89. The effectiveness score is 7.11 and the side effect score is 6.22. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Remeron review by 49 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   anxiety, depression, panic attacks
Dosage & duration:   15mg taken one half twice per day for the period of couple of years, still take it
Other conditions:   hypokalemia, panic disorder
Other drugs taken:   Tranxene, K-Tabs
  
Reported Results
Benefits:   Felt 'normal' rather than in a state of panic and anxiety. Thoughts were clearer and not racing. Felt calm and peaceful.
Side effects:   I was told patients can gain weight on it - i didn't. (apparently you eat more, that's where the extra weight comes from)....can make you tired, which for me is good, as i'm very hyperactive.
Comments:   After trying many anti-depressants, anti-anxiety and panic drugs - sometimes alone, sometimes in combination, nothing really worked for years until i tried (and continue to use) Remeron. It has made a *world* of difference to me and my quality of life. Started out on 7.5 mg one per day - gradually increased it. Too much made me sleepy, but found a right balance. Wish i knew about the drug many many years ago.

 

Remeron review by 47 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   30mg taken 1/day for the period of 4 months
Other conditions:   insomnia
Other drugs taken:   none
  
Reported Results
Benefits:   Boosted my mood a fair amount. My MD chose this med because I was having significant insomnia, and it definitely helped that, which was great.
Side effects:   But after I had caught up on my sleep, I felt very grogged out, even in the daytime. This was not acceptable, and I soon stopped the med.
Comments:   Took before med to help with sleep and avoid daytime grogginess. But it still made me groggy during the day.

 

Remeron review by 22 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Depression
Dosage & duration:   15mg taken x1/day for the period of 1 1/2 months
Other conditions:   Anxiety, chronic pain
Other drugs taken:   Wellbutrin
  
Reported Results
Benefits:   No apparent benefits. Had virtually no effect on my depression and it quickly became intolerable to use.
Side effects:   Extreme drowsiness, weight gain.
Comments:   Had virtually no effect on my depression and the side effects were intolerable. Took it at bedtime but was still quite groggy throughout the day. Gained about 25lbs before I stopped it.

See all Remeron reviews / ratings >>

Page last updated: 2014-07-25

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