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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)

Depression Plus BP Extremes May Increase CV Event Risks
Source: theheart.org | Medscape Cardiology Headlines [2015.08.29]
Both high and low systolic BP in patients with depressive symptoms were predictors of poor outcomes. However, associations with diastolic BP were another matter.
Heartwire from Medscape

ESC: Coffee, Naps, and Depression in Hypertension (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.29]
(MedPage Today) -- Observations support naps but suggest risk with espresso and depression

Goth Teens: Special Risk Seen for Depression, Self-Harming (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.29]
(MedPage Today) -- More identification with goth culture increases risk

About 10 percent of mothers experienced depression 2 years after Hurricane Katrina, study shows
Source: Aid / Disasters News From Medical News Today [2015.08.28]
About 10 percent of mothers experienced chronic, persistent depressive symptoms two years after Hurricane Katrina slammed into the Gulf Coast, killing more than 1,800 people, displacing hundreds of...

Goth teens could be more vulnerable to depression and self-harm
Source: Depression News From Medical News Today [2015.08.28]
Young people who identify with the goth subculture might be at increased risk of depression and self-harm, according to new research published in The Lancet Psychiatry journal.

more news >>

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. [2013]
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. [2013]
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.

more studies >>

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 weight loss.

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 8 weeks.

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

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. 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. 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.

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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: 2015-08-29

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