Mirtazapine (Mirtazapine) - Summary

MIRTAZAPINE SUMMARY

MIRTAZAPINE TABLETS, USP

Mirtazapine tablets are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds.

Mirtazapine tablets are indicated for the treatment of major depressive disorder.

The efficacy of mirtazapine 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 mirtazapine in hospitalized depressed patients has not been adequately studied.

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

See all Mirtazapine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Mirtazapine

TMS for Resistant Depression: Long-term Results Are In
Source: Medscape Medical News Headlines [2013.05.24]
Transcranial magnetic stimulation appears to be effective and durable in patients with treatment-resistant depression, new research shows.
Medscape Medical News

Early Identification And Treatment Of Postpartum Depression Can Limit Or Prevent Debilitating Effects
Source: Depression News From Medical News Today [2013.05.23]
The epigenetic modifications, which alter the way genes function without changing the underlying DNA sequence, can apparently be detected in the blood of pregnant women during any trimester, potentially providing a simple way to foretell depression in the weeks after giving birth, and an opportunity to intervene before symptoms become debilitating...

Do Migraines, Depression Shrink the Brain? (CME/CE)
Source: MedPage Today Neurology [2013.05.23]
(MedPage Today) -- The combination of migraine and depression has been linked to lower brain volumes in older age, a population-based study showed, but clinical implications remain unclear.

Having Both Migraines, Depression May Mean Smaller Brain
Source: MedicineNet Depression Specialty [2013.05.23]
Title: Having Both Migraines, Depression May Mean Smaller Brain
Category: Health News
Created: 5/22/2013 4:35:00 PM
Last Editorial Review: 5/23/2013 12:00:00 AM

Identifying Risk Factors For Depression Among COPD Patients
Source: Respiratory / Asthma News From Medical News Today [2013.05.22]
Patients suffering from chronic obstructive pulmonary disease (COPD) typically suffer from depression more frequently than those without COPD, resulting in higher levels of disability and illness and increasing the overall healthcare burden for the COPD population...

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Published Studies Related to 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 Mirtazapine

PET Neuroimaging of [11C]Mirtazapine [Completed]
Recent studies show that 25 – 30% of depressed patients never fully recover, resulting in a treatment-resistant condition. Thus, depression is a major cause of human suffering. We are interested in finding new ways of identifying and alleviating treatment-resistant depression, and we believe that recent advances in brain imaging can contribute to achieving that goal. In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented for examining the neurochemistry of brain receptors involved in antidepressant actions.

Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic receptors that have often been implicated in “stress reactions” as well as depressive disorders. We believe that our compound can identify specific molecular brain dysfunctions that are causally related to treatment-resistant depression.

The purpose of this study is to determine whether there is a reliable relationship between the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and region-of-interest data analysis, using healthy volunteers who will receive a daily dose of mirtazapine (double-blind design with placebo, 7. 5 mg or 15 mg daily for 5 days). We believe that this project could provide a procedure for assessing brain function in treatment-resistant depression, with the aim of improving the guidelines for successful, evidence-based treatment of depression.

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.

Dose Response of Mirtazapine to Methamphetamine Induced Interest, Mood Elevation and Reward [Recruiting]
The primary purpose of this study is to determine if Mirtazapine will produce a decrease in interest in the drug, a decrease in mood elevation, and/or a decrease in reward when given before methamphetamine compared to placebo.

Participants will be screened with a psychiatric interview, medical history and physical, laboratory tests, drug of abuse screen and, if female, a urine pregnancy test. They will be provided written informed consent. They will be studied in a within-subjects examination of the subjective mood responses of mirtazapine and methamphetamine. Interactions between methamphetamine and mirtazapine will be assessed by pharmacokinetic studies. Each participant will be introduced to rating scales and cognitive tasks described below. Participants will remain in the research unit for 5 hours on each day that they receive study medication or placebo. They will spend five days in total on the research unit, one day separated by at least one day; then in two day blocks separated by at least one day from another two day block. A venous catheter will be placed for blood draws. Blood pressures and heart rates will be recorded and assessed. Participants will be randomized and double blinded to receive either placebo or mirtazapine orally two hours prior to the administration of randomized and double blinded methamphetamine or placebo in order to have the peak effects of the drugs overlap. VAS-mood, ARCI, GRS, POMS and POMS-E, neurocognitive tasks Trails A and B and Symbol digits modalities test will be administered prior to the mirtazapine or placebo dose, and repeated after the administration of methamphetamine or placebo. After the administration of methamphetamine or placebo, vital signs will be assessed every 15 minutes and the measures will be repeated until 120 minutes have passed from the initial dose of methamphetamine or placebo. Blood will be drawn at one, three and four hour marks for pharmacokinetic testing. This will be repeated on each testing day.

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.

more trials >>

Reports of Suspected Mirtazapine Side Effects

Completed Suicide (101),  Neuroleptic Malignant Syndrome (96),  Anxiety (84),  Convulsion (81),  Fall (80),  Toxicity TO Various Agents (80),  Confusional State (79),  Dizziness (74),  Depression (72),  Drug Interaction (71), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Mirtazapine review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Chronic insomnia
Dosage & duration:		30 mg taken take one hour before bed for the period of 7 months
Other conditions:		Anxiety, panic attacks
Other drugs taken:		Epilium
		Reported Results
Benefits:		-night time sleep (at least 5-6 hours per night), more"peaceful" state of mind, no anxiety attacks, better brain function( no "brain fog" from insomnia), better concentration skills,
Side effects:		Constant feeling of hunger( feeling of empty stomach even straight after meal), body weight increased, fluid retention around knees and ankles, very bad depression during first 1-1.5 weeks if taking medication( no withdrawal symptoms though while gradual stopping drug), drug made me sleepy and more tired than usual during the day, crankiness and bad moods in the morning, hard to wake up in the morning
Comments:		Hour before bed: 30 mg mirtazapine( avanza) and one 500 mg epilim-ec. Epilim is used in treatment as a mood stabiliser( was told by a doctor). Originally I took only 30 mg of mirtazapine before bed time but after a month of treatment I stopped sleeping again and doctor prescribed to take extra tablet epilim which worked very well and gave me very good deep sleep

Mirtazapine review by 19 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Depression, Anxiety, OCD, Nausea
Dosage & duration:		30mg taken once a day for the period of 7 months
Other conditions:		CFS, IBS, insomnia
Other drugs taken:		Lansoprazole, Loestrin 30
		Reported Results
Benefits:		Helped me easily get a good sleep. Possible reduction in IBS symptoms.
Side effects:		Too tired to get up in morning, irritability, couldn't get drunk anymore as I would drink loads and nothing would happen.
Comments:		Did little if anything for depression and anxiety. On 15mg things got worse and I got angry so easily but this went away on 30mg. I didn't put any weight on and I didn't feel very hungry on this drug and I thought that was supposed to happen.

Mirtazapine 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 once daily for the period of 2 Months
Other conditions:		Sleeplesness
Other drugs taken:		Nil
		Reported Results
Benefits:		Nil
Side effects:		-Insatiable hunger (added about 3kgs) -Constant Fatigue/grogginess -Dry Mouth at Night -Vivid Nightmares -Complete loss of labido (lame) I was pretty much miserable the entire time i was taking it, but was aware that it was supposed to start doing what it was supposed to after the first month or so, so I persevered.
Comments:		Taking before bed to help depression. Coming off the drug I felt awesome. Within a few days my energy returned as did my interest in my girlfriend. This drug was total crap. I'm now taking temazepam to help with sleeping and that is working pretty good most nights, no side effects.