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)
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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).
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NEWS HIGHLIGHTSMedia Articles Related to Remeron (Mirtazapine)
Depression As Deadly As Smoking, But Anxiety May Be Good For You
Source: Anxiety / Stress News From Medical News Today [2009.11.19]
A study by researchers at the University of Bergen, Norway, and the Institute of Psychiatry (IoP) at King's College London has found that depression is as much of a risk factor for mortality as smoking.
At-Risk College Students Reduce HBP, Anxiety, Depression Through Transcendental Meditation
Source: Anxiety / Stress News From Medical News Today [2009.11.18]
The Transcendental Meditation technique may be an effective method to reduce blood pressure, anxiety, depression, and anger among at-risk college students, according to a new study to be published in the American Journal of Hypertension, December 2009.
Symptoms Of Depression Improved By Motivational "Women-Only" Cardiac Rehab
Source: Depression News From Medical News Today [2009.11.18]
Depressive symptoms improved among women with coronary heart disease who participated in a motivationally-enhanced cardiac rehabilitation program exclusively for women, according to research presented at the American Heart Association's Scientific Sessions 2009. Depression often co-occurs with heart disease and is found more often in women with heart disease than in men.
Telephone-Delivered Care For Treating Depression After CABG Surgery Appears To Improve Outcomes
Source: Depression News From Medical News Today [2009.11.17]
Patients who received telephone-delivered collaborative care for treatment of depression after coronary artery bypass graft surgery reported greater improvement in measures of quality of life, physical functioning and mood than patients who received usual care, according to a study in the November 18 issue of JAMA. The study is being released early online because of its presentation at an American Heart Association scientific conference.
Treating depression after surgery speeds recovery (Reuters)
Source: Y! Health Depression News [2009.11.17]
Reuters - A simple telephone intervention improved mood, physical functioning, and overall quality of life in patients who were depressed after heart bypass surgery, researchers reported in a late breaking clinical trial here at the American Heart Association Scientific Sessions 2009.
Published Studies Related to Remeron (Mirtazapine)
Mirtazapine and paroxetine in major depression: a comparison of monotherapy versus their combination from treatment initiation. [2009.07]
This double-blind study compared initial combination therapy against monotherapy using two antidepressant drugs with complementary mechanisms of action on the serotonin (5-HT) and norepinephrine (NE) systems. Sixty one adult patients with a DSM-IV diagnosis of unipolar depression were randomized to receive mirtazapine (30 mg/day), paroxetine (20 mg/day), or the combination of both drugs for 6 weeks...
Influence of sex and CYP2D6 genotype on mirtazapine disposition, evaluated in Spanish healthy volunteers. [2009.06]
AIMS: To evaluate the influence of sex and CYP2D6 genotype on mirtazapine disposition within two bioequivalence studies in healthy volunteers... CONCLUSIONS: Both CYP2D6 genotype group and sex influence the disposition of mirtazapine in healthy volunteers and confirm reported data in the literature obtained by different methods. No sex-by-genotype interaction could be detected.
Early effects of mirtazapine on emotional processing. [2009.05]
BACKGROUND: Acute administration of selective serotonin and noradrenaline re-uptake blockers to healthy volunteers affects the processing of emotional information but it is not known if similar effects occur with antidepressants acting through other pharmacological mechanisms. Mirtazapine is a clinically established antidepressant with complex actions involving blockade of noradrenaline alpha(2)-adrenoceptors as well as a number of 5-HT receptor subtypes. The aim of the present study was to test whether, like monoamine re-uptake inhibitors, mirtazapine would also produce positive biases in emotional processing... CONCLUSIONS: Our findings indicate that mirtazapine reduces fear processing in healthy volunteers, an effect similar to that produced by repeated administration of selective serotonin re-uptake inhibitors. In addition, mirtazapine increased memory for likeable versus dislikeable self-relevant information suggesting an induction of positive bias in emotional memory. Such effects may be important for our understanding of the neuropsychological mechanisms of antidepressant action in both anxiety and depressive disorders.
Mirtazapine add-on therapy in the treatment of schizophrenia with atypical antipsychotics: a double-blind, randomised, placebo-controlled clinical trial. [2009.04]
OBJECTIVE: Schizophrenia is a multifaceted illness with positive, negative and cognitive symptom domains. Standard treatments often focus on positive symptoms and may not adequately relieve other symptoms. Previous studies have suggested a role for mirtazapine in schizophrenia, particularly in negative symptoms. This study investigates the efficacy of adding mirtazapine to treatment as usual to alleviate the negative symptoms of schizophrenia... CONCLUSIONS: This trial does not confirm previous research supporting the use of mirtazapine adjunctive to atypical antipsychotic treatment for schizophrenia.
Mirtazapine, a sedating antidepressant, and improved driving safety in patients with major depressive disorder: a prospective, randomized trial of 28 patients. [2009.03]
CONCLUSION: A sedating antidepressant can increase driving safety in MDD patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00385437.
Clinical Trials Related to Remeron (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.
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.
Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects [Recruiting]
This research study is being done to to look at the safety of the medication Mirtazapine
(Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage
will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A
greater increase in Clinician Global Impression (CGI) score will be observed in the MG than
in the CG. Secondary Hypotheses: I. A greater decrease in Hamilton Rating Scale for
Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores will be observed in
the MG than in the CG. II. A greater decrease in HIV risk behaviors will be observed in the
MG than in the CG. III. A greater improvement in sleep structure will be observed in the MG
than in the CG. IV. The proportion of subjects experiencing severe adverse drug reactions
that necessitate termination from the study by one of the study clinicians will not differ
between the MG and CG. V. Retention will be greater in MG than in CG.
Mirtazapine to Reduce Methamphetamine Use Among MSM With High-Risk HIV Behaviors [Recruiting]
Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual
behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or
acquiring HIV. This study of intermediate size (60 participants) and length (3 months of
follow-up) will assess the efficacy of mirtazapine in reducing methamphetamine use among
high-risk MSM.
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 4 ratings/reviews, Remeron has an overall score of 6.50. The effectiveness score is 7 and the side effect score is 6.50. 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. |
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| | 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. |
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| | 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. |
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Page last updated: 2009-11-19
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