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).
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Published Studies Related to Remeron (Mirtazapine)
Study of the use of antidepressants for depression in dementia: the HTA-SADD
trial--a multicentre, randomised, double-blind, placebo-controlled trial of the
clinical effectiveness and cost-effectiveness of sertraline and mirtazapine. 
compared with placebo... CONCLUSIONS: This is a trial with negative findings but important clinical
Relationships between pharmacotherapy-induced metabolic changes and improved
psychopathology in schizophrenia: data from a mirtazapine and first-generation
antipsychotics combination trial. 
Clinical efficacy and metabolic side-effects of antipsychotics seem to correlate
with each other. In this study, interrelationship of similar metabolic effects of
mirtazapine and its earlier reported desirable effects on psychopathology in
first-generation antipsychotics (FGAs)-treated schizophrenia were explored...
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.
Clinical Trials Related to Remeron (Mirtazapine)
Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight [Terminated]
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 [Completed]
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
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
Study of Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Fibromyalgia Syndrome [Completed]
This study aims to investigate the anti-nociceptive biogenic amine (serotonin
[5-hydroxytryptamine; 5-HT], norepinephrine [NE], dopamine [DA], and their metabolites)
status, and serum levels of cytokines, BDNF and BH4 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,
cytokines, BDNF and BH4 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 co-primary
outcome variable will be the changes in the pain visual analog scale (PVAS) score and pain
responders (>= 30% PVAS reduction). 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, fibromyalgia impact
questionnaire (FIQ, 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. Higher cytokines could be observed in FMS patients.
4. Higher BDNF could be observed in FMS patients.
5. Lower BH4 could be observed in FMS patients.
6. Mirtazapine is effective in FMS treatment.
Clinical Studies on the Therapeutic Effects of Mirtazapine on Drug-craving in Cocaine Addicts. [Completed]
INTRODUCTION. One of the main problems of the treatment of cocaine-dependent patients is the
high rate of relapses occurs within the first months after detoxification. In the early
withdrawal phase, patients suffer severe anxious depressive symptoms, known in the argot as
crash, which occurs in parallel with an appetite overflowed by re-experiencing the effects
of the substance, known as craving. Most of the times, these clinical symptoms act as
negative reinforcement, which can be severe enough to induce a drug-relapse that greatly
hampers the treatment.
TYPE OF STUDY randomized, double-blind, placebo-experimental. GENERAL PURPOSE To determine
the efficacy of mirtazapine for the treatment of cocaine dependence. SPECIFIC OBJECTIVES 1)
To evaluate the efficacy in the treatment of craving in individuals with cocaine dependence
disorder treated with mirtazapine during acute withdrawal phase. 2) Determine the efficacy
of reducing anxious depressive symptomatology (Crash) associated with acute withdrawal in
subjects with cocaine dependence disorder treated with mirtazapine. 3) Evaluate the
maintenance of abstinence in patients with cocaine dependence disorder treated with
mirtazapine. 4) Determine the efficacy of mirtazapine in the treatment of subjects dependent
on cocaine comorbid with major depressive disorder.
HYPOTHESIS For pharmacokinetics and pharmacodynamics mirtazapine contribute to the reduction
in the intensity of withdrawal symptoms in cocaine dependent subjects by acting on the
neurochemical circuitry involved in the reward-seeking behavior and has a prolonged effect
anticraving. METHOD The attending physician outpatient identifies the Addiction Clinic of
the National Institute of Psychiatry who meet the inclusion criteria and invite them to
participate voluntarily. If patients accept, send them to the principal investigator for the
start of the ratings. Demographics INSTRUMENTS, MINI structured interview, Anxiety and
Depression Scale Beck Scale.
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: 2016-06-25