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 WELLBUTRIN XL 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. WELLBUTRIN XL 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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WELLBUTRIN XL SUMMARY
WELLBUTRIN XL®
(bupropion hydrochloride extended-release tablets)
WELLBUTRIN XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride.
WELLBUTRIN XL is indicated for the treatment of major depressive disorder.
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure 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 efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use WELLBUTRIN XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
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WELLBUTRIN XL NEWS HIGHLIGHTS
Published Studies Related to Wellbutrin XL (Bupropion)
A controlled trial of bupropion added to nicotine patch and behavioral therapy for smoking cessation in adults with unipolar depressive disorders. [2008.12]
Although there is a strong relationship between depression and smoking, most nicotine dependence treatment trials exclude depressed smokers. Our objective was to determine whether bupropion [generic for Wellbutrin XL] improves abstinence rates and abstinence-associated depressive symptoms when added to transdermal nicotine replacement therapy (NRT) and group cognitive behavioral therapy (CBT) in smokers with unipolar depressive disorder (UDD)...
Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis. [2008.11]
OBJECTIVES: To evaluate varenicline's efficacy for smoking cessation versus bupropion [generic for Wellbutrin XL] SR and placebo and to explore whether factors typically predictive of abstinence influence varenicline's efficacy versus placebo, as measured by the week 9-12 continuous abstinence rate (CAR9-12)... CONCLUSIONS: Varenicline was more efficacious than bupropion SR or placebo. Varenicline's efficacy versus placebo was not influenced by factors predictive of abstinence.
Psychological mediators of bupropion sustained-release treatment for smoking cessation. [2008.09]
AIM: The study aimed to test simultaneously our understanding of the effects of bupropion [generic for Wellbutrin XL] sustained-release (SR) treatment on putative mediators and our understanding of determinants of post-quit abstinence, including withdrawal distress, cigarette craving, positive affect and subjective reactions to cigarettes smoked during a lapse. The specificity of bupropion SR effects was also tested in exploratory analyses... CONCLUSIONS: Results provided some support for models of bupropion SR treatment and relapse and suggested that motivational processes may partially account for bupropion SR efficacy.
Randomized, placebo-controlled trial of bupropion for the treatment of methamphetamine dependence. [2008.08.01]
OBJECTIVE: To compare bupropion [generic for Wellbutrin XL] to placebo for reducing methamphetamine (MA) use, increasing retention, and reducing the severity of depressive symptoms and MA-cravings. A secondary objective compared bupropion to placebo for reducing cigarette smoking among MA dependent participants... CONCLUSION: Bupropion was no more effective than placebo in reducing MA use in planned analyses, though bupropion did reduce cigarette smoking. Post hoc findings of an effect for bupropion among baseline light, but not heavy, MA users suggests further evaluation of bupropion for light-MA users is warranted.
Efficacy of bupropion and the selective serotonin reuptake inhibitors in the treatment of major depressive disorder with high levels of anxiety (anxious depression): a pooled analysis of 10 studies. [2008.08]
CONCLUSIONS: There appears to be a modest advantage for the SSRIs compared to bupropion [generic for Wellbutrin XL] in the treatment of anxious depression (6% difference in response rates). Using the number-needed-to-treat (NNT) statistic as 1 indicator of clinical significance, nearly 17 patients would need to be treated with an SSRI than with bupropion in order to obtain 1 additional responder. This difference falls well above the limit of NNT = 10, which was suggested by the United Kingdom's National Institute of Clinical Excellence. Nevertheless, the present work is of theoretical interest because it provides preliminary evidence suggesting a central role for serotonin in the regulation of symptoms of negative affect such as anxiety.
Clinical Trials Related to Wellbutrin XL (Bupropion)
Wellbutrin XL, Major Depressive Disorder and Breast Cancer [Completed]
- To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment
of Major Depressive Disorder in women with breast cancer.
- To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these
patients
The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity [Completed]
The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL
(bupropion hydrochloride) on reward processing.
Randomized Trial of Ultrashort Psychotherapy vs Sustained-Release Bupropion for Smoking Cessation [Completed]
Background
Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are
notoriously under-evaluated.
Methods
We conducted a randomized clinical trial in which we compared a medication, i. e.,
sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most
efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic
intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically
oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported
continuous abstinence confirmed by urine cotinine levels below the level of detection (13
ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all
interviews conducted at 3, 6, and 12 months.
Chantix & Bupropion for Smoking Cessation [Active, not recruiting]
The overarching goal of this line of research is to increase smoking abstinence rates using a
combination of existing pharmacotherapies. The aim of the current study is to assess the
safety and compliance as well as obtain preliminary estimates of efficacy and effect on
craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We
will compare the efficacy estimates in this study with historical smoking abstinence rates
with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an
open-label, phase II clinical trial.
Wellbutrin XL for Dysthymic Disorder [Completed]
This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic
disorder, a form of low-grade chronic depression. We hypothesize that patients taking
Wellbutrin XL will show greater improvement in depression symptoms and psychosocial
functioning than patients taking placebo.
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WELLBUTRIN XL PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 24 ratings/reviews, Wellbutrin XL has an overall score of 7.96. The effectiveness score is 8.08 and the side effect score is 7.92. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Wellbutrin XL review by 38 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Chronic depression |
| Dosage & duration: | | 300 mg taken once a day for the period of two years |
| Other conditions: | | ADD |
| Other drugs taken: | | Dexedrine | | |
Reported Results |
| Benefits: | | Significant improvement in mood, affect, energy, libido, and overall mental status. Significant reduction in anxiety, moodiness, and certain obsessive compulsive traits. |
| Side effects: | | None |
| Comments: | | Patient suffering from severe depression prior to medication. Had taken Wellbutrin SR in the past with moderate side effects and moderate improvement in depression. Attending psychiatrist prescribed Wellbutrin XL at a higher dose in conjunction with Dexedrine for ADD. Marked improvement in depression and ADD symptoms. Patient still taking medication. |
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| | Wellbutrin XL review by 31 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 150 mg taken daily for the period of 1 year |
| Other conditions: | | anxiety |
| Other drugs taken: | | Lexapro | | |
Reported Results |
| Benefits: | | Aided in decreasing symptoms of depression, and also reduced craving for cigarettes as a bonus. Noticeably less lethargy. |
| Side effects: | | Side effects were generally positive, including help with smoking cessation as well as increased libido, which had decreased on Lexapro. |
| Comments: | | In conjunction with taking Lexapro for anxiety, Wellbutrin XL was taken (150 mg/day) to reduce depression and balance the side effects of Lexapro, including lethargy, weight gain and sexual dysfunction. Lexapro was taken in evening, Wellbutrin XL in the morning. |
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| | Wellbutrin XL review by 53 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | lose weight |
| Dosage & duration: | | 300mg taken 1x day for the period of 2 weeks |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Positive- increased libido |
| Side effects: | | Negative- 1)significant increase in breast pain on one side, leading to bloody discharge after only 2 weeks of taking drug 2)'coursing' feeling through veins on same side as breast pain 3)humongous hard pimple formed near nose. |
| Comments: | | Discontinued treatment due to side effects. I would consider taking again if the negative side effects were noted in literature as temporary and insignificant over the long term |
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Page last updated: 2009-02-07
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