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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NEWS HIGHLIGHTS
Published Studies Related to Wellbutrin XL (Bupropion)
The impact of chronic bupropion on plasma cotinine and on the subjective effects of ad lib smoking: A randomized controlled trial in unmotivated smokers. [2009.09.14]
Bupropion is an efficacious non-nicotine medication for smoking cessation; however, its cessation-mediating mechanism is unclear. This randomized, placebo-controlled trial examined the effect of bupropion SR (300mg/day for 6weeks) on plasma cotinine and on the subjective effects of smoking in 24 current daily smokers who were not trying to quit or reduce smoking...
A randomized, controlled trial of bupropion sustained-release for preventing tobacco relapse in recovering alcoholics. [2009.07]
INTRODUCTION: Studies examining the efficacy of tobacco dependence treatment among recovering alcoholic smokers have produced mixed findings... DISCUSSION: Treatment with bupropion SR among abstinent alcoholic smokers did not delay relapse or result in improved long-term smoking abstinence.
Eight-week, placebo-controlled, double-blind comparison of the antidepressant efficacy and tolerability of bupropion XR and venlafaxine XR. [2009.07]
The efficacy, safety and tolerability of bupropion XR and venlafaxine XR was assessed and compared with placebo in adult outpatients with major depressive disorder (MDD). Adults meeting DSM-IV criteria for MDD with a minimum Hamilton Depression Rating Scale (HAMD) 17-Item total score of > or =18 were randomized to eight weeks of double-blind treatment with either bupropion XR (150 mg/day), venlafaxine XR (75 mg/day) or placebo...
Sustained-release bupropion for hospital-based smoking cessation: a randomized trial. [2009.06]
INTRODUCTION: Bupropion is a first-line pharmacological aid for smoking cessation; however, no clinical trials have been conducted in a general population of hospitalized smokers.Because of the secular trend toward shorter hospital stays, recruitment was very difficult, raising questions regarding the feasibility of future hospital-based smoking cessation trials and interventions.
A preliminary trial: double-blind comparison of nefazodone, bupropion-SR, and placebo in the treatment of cannabis dependence. [2009.01]
The present study investigated the efficacy of nefazodone and bupropion-sustained release for treating cannabis dependence. A double-blind, placebo-controlled, piggy back design was employed to assess if nefazodone and bupropion-sustained release increased the probability of abstinence from cannabis and reduced the severity of cannabis dependence and cannabis withdrawal symptoms during a 13-week outpatient treatment program...
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 XLâ„¢) in the treatment
of Major Depressive Disorder in women with breast cancer.
- To evaluate the tolerability of bupropion extended-release (Wellbutrin XLâ„¢) 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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 30 ratings/reviews, Wellbutrin XL has an overall score of 7.90. The effectiveness score is 7.87 and the side effect score is 7.87. 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 49 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | anti-depressant |
| Dosage & duration: | | 350 (dosage frequency: once a day) for the period of 2 years |
| Other conditions: | | n/a |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The biggest benefit was when I quit smoking, because I had been taking it for a while...it proved to assist with the cravings...it's probably why I was able to quit in the first place. |
| Side effects: | | Made me kind of grumpy and a little weight gain. |
| Comments: | | Started taking anti-depressant when my Mother passed away. Started a low-dose and increased over a period of 3 months. I believe Wellbuterin was very beneficial and did not have major side effects. I stopped taking them 2 months ago and haven't had any withdrawal symptoms. |
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| | Wellbutrin XL review by 56 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 150mg taken every am for the period of on going |
| Other conditions: | | thyroid, high cholesterol |
| Other drugs taken: | | Synthroid 25mg Simvastaton 20mg | | |
Reported Results |
| Benefits: | | Yes, I had taken Prozac for fourteen to fifteen years for the treatment of depession and experienced a loss of sexual desire. I tried the Wellbutrin XL in the hopes that it would not produce this side effect starting about 18 months ago. The Wellbutrin XL does not have this side effect in my experience. |
| Side effects: | | I have not noticed side effects. I was hoping that a good side effect would be that it would help me quit smoking. It hasn't. |
| Comments: | | I don't have any details. Have thought about asking my doctor to up the dosage when I was having a bout of feeling "down" but it passed and I didn't. |
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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: 2009-10-20
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