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® (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).
Media Articles Related to Remeron (Mirtazapine)
Activating neurons that trigger depression could help treat it, study suggests
Source: Anxiety / Stress News From Medical News Today [2014.04.19]
Researchers from the Icahn School of Medicine at Mount Sinai found that activating neurons linked to stress-induced depression may actually increase resilience to the condition.
Stroke Rounds: Depression Tied to Worse Stroke Outcomes (CME/CE)
Source: MedPage Today Cardiovascular [2014.04.17]
(MedPage Today) -- Depression was found to be a significant and independent risk factor for poor stroke outcomes in a study from the U.K., and recovery from depression within a year did not alter long-term risk.
Symptoms of depression surge in young men during early fatherhood
Source: Depression News From Medical News Today [2014.04.16]
Depression can hit young fathers hard -- with symptoms increasing dramatically during some of the most important years of their children's lives, a new Northwestern MedicineR study has found.
Study: When depression does not respond to treatment
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2014.04.15]
Notwithstanding numerous advances in the pharmacological treatment of depression, approximately 70% of patients do not remit after first-line antidepressant treatment.
Preschool Depression Strong Predictor of Later MDD
Source: Medscape Psychiatry & Mental Health Headlines [2014.04.14]
Preschoolers with depressive syndrome run a significantly increased risk for major depression later in childhood.
Medscape Medical 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.
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
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
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.
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
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
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
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
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.
Reports of Suspected Remeron (Mirtazapine) Side Effects
Suicide Attempt (47),
Multiple Drug Overdose Intentional (30),
Chronic Obstructive Pulmonary Disease (22),
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
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|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|
|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
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || depression|
|Dosage & duration:|| || 30mg taken 1/day for the period of 4 months|
|Other conditions:|| || insomnia|
|Other drugs taken:|| || none|
|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
|Overall rating:|| || |
|Effectiveness:|| || Ineffective|
|Side effects:|| || Severe Side Effects|
|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|
|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.|
Page last updated: 2014-04-19