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 Aplenzin™ 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. Aplenzin is not approved for use in pediatric patients. [See
WARNINGS AND PRECAUTIONS: Clinical Worsening and Suicide Risk and USE IN SPECIFIC POPULATIONS: Pediatric Use
]
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APLENZIN SUMMARY
Aplenzin (bupropion hydrobromide), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents.
Aplenzin™ (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder.
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NEWS HIGHLIGHTS
Published Studies Related to Aplenzin (Bupropion)
The DRD4 Exon III VNTR, Bupropion, and Associations With Prospective Abstinence. [2012]
cognitive-behavioral mood management therapy... CONCLUSIONS: VNTR by treatment interaction
A retrospective analysis of two randomized trials of bupropion for
methamphetamine dependence: suggested guidelines for treatment
discontinuation/augmentation. [2012]
BACKGROUND: Two clinical trials have shown efficacy for bupropion in treating
methamphetamine (MA) dependence among those with moderate baseline MA use. However, treatment response is highly variable and it is unclear what duration of
treatment is necessary to determine if maintaining the treatment course is
indicated or if discontinuation or augmentation is appropriate.
Smoking cessation pharmacogenetics: analysis of varenicline and bupropion in
placebo-controlled clinical trials. [2012]
Despite effective therapies for smoking cessation, most smokers find quitting
difficult and most successful quitters relapse. Considerable evidence supports a
genetic risk for nicotine dependence; however, less is known about the
pharmacogenetics of smoking cessation... Different loci are associated with varenicline vs bupropion
response, suggesting that additional research may identify clinically useful
markers to guide treatment decisions.
Effects of varenicline and bupropion on cognitive processes among
nicotine-deprived smokers. [2012]
Nicotine deprivation is associated with craving, negative affect, and difficulty
concentrating, which may contribute to subsequent relapse... Identifying these mechanisms may help in the development of new
pharmacological treatments.
Bupropion sustained release added to group support for smoking cessation in
schizophrenia: a new randomized trial and a meta-analysis. [2012]
CONCLUSIONS: New clinical trial data and a meta-analysis strongly support the
Clinical Trials Related to Aplenzin (Bupropion)
Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions [Recruiting]
The objective of this study is to evaluate the comparative bioavailability between bupropion
hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL®
300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients
under fasting conditions.
Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial [Recruiting]
Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent
event or death compared with those who quit. Many patients attempt to stop smoking after a
heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been
shown to be effective for the general population. However, bupropion is the only
non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers.
Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate
period following a heart attack because of the undesirable effects of nicotine. Although
bupropion has been successfully used to reduce smoking rates in healthy young populations,
its efficacy and safety in the setting of patients recovering from an ACS is unknown. These
patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac
events. If bupropion is effective in this population, it will have a major impact on
secondary prevention of recurrent clinical events in patients who suffer a heart attack.
Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients [Not yet recruiting]
This is a multi center, open-label study to study the drug-drug interaction of LDE225 on the
PK of warfarin and bupropion in patients with advanced solid tumors. Subjects will receive
800mg daily of LDE225 and two separate doses of either bupropion or warfarin.
The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior [Recruiting]
The purpose of this study is to examine how smoking cessation medications (varenicline,
bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in
non-treatment seeking daily smokers.
Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype [Recruiting]
Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation
treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit
from prescription treatment alternatives, including Zyban or Chantix. In this study, the
investigators propose to develop and evaluate a stepped-care treatment algorithm that would
evaluate whether smokers who receive treatment with NRT should be supplemented with Zyban or
switched to Chantix only based on: 1) their initial response to NRT; and 2) individual
genetic factors found to predict smoking cessation in other studies evaluating these
treatments. This study is a continuation of our previous studies showing that abstinence
rates can be increased by starting nicotine patch therapy two weeks before the quit date.
The investigators will provide pre-cessation NRT to all participants initially. Those who
do not show a favorable response on early indicators of success (e. g., smoking in the first
week after the target quit-smoking date) will receive "rescue" treatment by having their NRT
treatment supplemented with Zyban , by being switched to treatment with Chantix or will
remain on NRT (control).
The investigators hypothesize that "Rescue" treatment with Zyban in combination with NRT or
Chantix will increase success rates over leaving subjects on NRT when they are NRT
insufficient responders, i. e. they have shown an unfavorable response to NRT in the first
week pre-quit or the first week post-quit.
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Page last updated: 2013-02-10
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