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 EMSAM 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 for the need for close observation and communication with the prescriber. EMSAM is not approved for use in pediatric patients. Furthermore, EMSAM at any dose should not be used in children under the age of 12, even when administered with dietary modifications. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
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EMSAM SUMMARY
EMSAM® (selegiline transdermal system) is a transdermally administered antidepressant. When applied to intact skin, EMSAM is designed to continuously deliver selegiline over a 24-hour period.
EMSAM (selegiline transdermal system) is indicated for the treatment of major depressive disorder.
The efficacy of EMSAM in the treatment of major depressive disorder was established in 6- and 8-week placebo-controlled trials of outpatients with diagnoses of DSM-IV category of major depressive disorder (see Clinical Efficacy Trials).
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, and suicide attempt or suicidal ideation.
The benefit of maintaining patients with major depressive disorder on therapy with EMSAM after achieving a responder status for an average duration of about 25 days was demonstrated in a controlled trial (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). The physician who elects to use EMSAM for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
The antidepressant action of EMSAM in hospitalized depressed patients has not been studied.
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NEWS HIGHLIGHTSMedia Articles Related to Emsam (Selegiline Transdermal)
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 Emsam (Selegiline Transdermal)
Efficacy of selegiline add on therapy to risperidone in the treatment of the negative symptoms of schizophrenia: a double-blind randomized placebo-controlled study. [2008.03]
OBJECTIVE: It has been reported that selegiline, a Selective Monoamine Oxidase Inhibitor B (MAOI-B), at low doses would be helpful for treating negative symptoms in schizophrenia. Nevertheless, the results are contradictory so far. This study was designed to investigate the effect of selegiline added to risperidone as augmentation therapy in patients with chronic schizophrenia and prominent negative symptoms in an 8 week, double blind and randomized clinical trial... CONCLUSION: The present study indicates selegiline as a potential adjunctive treatment strategy for the negative symptoms of schizophrenia. Nevertheless, results of larger controlled trials are needed before recommendation for a broad clinical application can be made. (c) 2007 John Wiley & Sons, Ltd.
A review of the literature on the selegiline transdermal system: an effective and well-tolerated monoamine oxidase inhibitor for the treatment of depression. [2008]
Objective: To provide a narrative review of the properties of the selegiline transdermal system (STS) for the treatment of depression and its subtypes.Background: Monoamine oxidase inhibitors (MAOIs) once represented the mainstay of therapy for the treatment of major depressive disorder (MDD)... As a result, treatment at the lowest effective dose of 6 mg/24 hours can be administered without the need for dietary modifications.
Selegiline transdermal system (STS) for HIV-associated cognitive impairment: open-label report of ACTG 5090. [2007.11]
CONCLUSION: Long-term use of selegiline was safe and well tolerated in this HIV cohort of HIV with cognitive impairment. Cognitive improvement may be delayed in neuroprotective trials, suggesting that trials longer than 6 months may be necessary to assess the efficacy of putative neuroprotective agents.
Pharmacokinetics and absolute bioavailability of selegiline following treatment of healthy subjects with the selegiline transdermal system (6 mg/24 h): a comparison with oral selegiline capsules. [2007.10]
The selegiline transdermal system is a monoamine oxidase inhibitor that was recently approved by the US Food and Drug Administration for the treatment of major depressive disorder. The current study was conducted during the selegiline transdermal system development program to characterize the single-dose pharmacokinetics and absolute bioavailability of selegiline administered by the 6-mg/24-h selegiline transdermal system in healthy volunteers...
A multicenter trial of selegiline transdermal system for HIV-associated cognitive impairment. [2007.09.25]
BACKGROUND: Cognitive impairment continues to be a significant neurologic complication of HIV infection and has been associated with oxidative stress-induced neuronal injury. Selegiline is an MAO-B inhibitor with antioxidant and neurotrophic properties. This rationale has led to the design and implementation of this Selegiline Transdermal System (STS) study with the primary aims of assessing safety and tolerability of STS as well as improvement in cognitive performance... CONCLUSION: Selegiline was safe and well tolerated by HIV-infected individuals with cognitive impairment and mild to moderate immune suppression; however, no cognitive or functional improvement was observed in this phase II study.
Clinical Trials Related to Emsam (Selegiline Transdermal)
Evaluation of Adhesion and Dermal Tolerability of EMSAM [Completed]
PK Comparison of 6mg and 12mg EMSAM in Elderly vs. Non-Elderly [Completed]
Evaluate the effect of age on the PK of two different doses of EMSAM.
Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients [Active, not recruiting]
A decrease in mental function often occurs in patients with HIV. Antiretroviral (ARV) drugs
are used to treat this but are not entirely effective. Some other therapy could play a role.
The drug selegiline in its pill form is used to treat Parkinson's disease, a serious brain
disorder. It is believed this drug might protect the brain and repair some damage. This study
will use this drug in a "patch" form, which has not been approved by the Food and Drug
Administration (FDA), to see if it helps with decreased mental function in patients with HIV.
The purpose of this study is to evaluate the use of selegiline transdermal system (STS) in
the treatment of decreased mental function in patients with HIV.
Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease [Recruiting]
Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is
primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction
with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations
for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in
the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B
(MAO-B) activity is generally considered to be of primary importance.
Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg
daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of
selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in
the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and
avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a
lower dose. Consequently, Zelapar is dosed once-daily, up to 2. 5 mg per day. There are no
empirical data indicating whether the use of the new approved formulation of selegiline ODT
(Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is
believed that clinical efficacy will be preserved or enhanced, by delivering more active
drug, with improved patient preference for the ODT formulation due to the once-daily dosing
.
The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in
the treatment of PD was established in a multicenter randomized placebo-controlled trial
(n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months'
duration. Patients randomized to orally disintegrating selegiline received a daily dose of
1. 25 mg for the first 6 weeks and a daily dose of 2. 5 mg for the last 6 weeks. Patients were
all treated with levodopa and could additionally have been on dopamine agonists,
anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks,
orally disintegrating selegiline-treated patients had an average of 2. 2 hours per day less
"OFF" time compared to baseline. Placebo treated patients had 0. 6 hours per day less "OFF"
time compared to baseline. These differences were significant (p < 0. 001). Adverse events
were very similar between drug and placebo.
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression [Recruiting]
The primary purpose of your participation in this study is to help answer the following
research question: Whether 12-week administration of EMSAM (selegiline transdermal system)
is safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major
Depressive Disorder.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 4 ratings/reviews, Emsam has an overall score of 7. The effectiveness score is 7.50 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Emsam review by 41 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | major chronic depressive disorder |
| Dosage & duration: | | 20mg (6mg/24h) taken once daily for the period of one year |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I had become so severly depressed that I was incapable of holding a job. My doctor had tried virtually all classifications of meds on the market but none were able to pull me out of the state I was in. My world had become so dark I felt the sun would never shine again. This med allowed me to function again within my family and within the working world. I stopped crying all the time and was able to concentrate and perform the tasks necessary for employment. I got my life back. |
| Side effects: | | Unlike other antidepressants with numerous side effects, this med had no internal side effects. The only complaint I had with this med was the skin irritation at the application site. This I treated with moisturizers and hydrocortisone creams. |
| Comments: | | I simply applied one patch daily to any part of the "trunk" area of my body. It was not a drug I had to be introduced to slowly or weaned off of. I found that the lowest dose available was effective for me. Each day before my shower the previous days patch was removed so the site area could be cleansed. After my shower the new patch was applied in a different location. |
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| | Emsam review by 57 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | I don't remember (dosage frequency: appllied patch in the morning) for the period of 2 months |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | None |
| Side effects: | | I became increasingly agitated and angry. After being on it for 2 months, I tried to commit suicide. |
| Comments: | | I had been taking Effexor, Welbutrin and Ritalin for over three years. The combination worked better then any other cocktail I'd taken. I complaine3d to Doctor that I was feeling lethargic so he switched me to Emsam. After a month he increased the dose. I attempted suicide. Found a new doctor.. Now taking cymbalta and welbutrin. Which seem to be working OK but they ain't no miracle drug. |
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| | Emsam review by 57 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | I don't remember (dosage frequency: appllied patch in the morning) for the period of 2 months |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | None |
| Side effects: | | I became increasingly agitated and angry. After being on it for 2 months, I tried to commit suicide. |
| Comments: | | I had been taking Effexor, Welbutrin and Ritalin for over three years. The combination worked better then any other cocktail I'd taken. I complaine3d to Doctor that I was feeling lethargic so he switched me to Emsam. After a month he increased the dose. I attempted suicide. Found a new doctor.. Now taking cymbalta and welbutrin. Which seem to be working OK but they ain't no miracle drug. |
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Page last updated: 2009-11-19
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