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 SR 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 SR 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 SR SUMMARY
WELLBUTRIN SRŪ (bupropion hydrochloride) Sustained-Release Tablets
WELLBUTRIN SR (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents.
WELLBUTRIN SR is indicated for the treatment of depression.
The efficacy of bupropion in the treatment of depression was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed 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 five 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 WELLBUTRIN SR in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use WELLBUTRIN SR 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 SR (Bupropion)
Interactions between bupropion and 3,4-methylenedioxymethamphetamine in healthy
subjects. [2015] 3,4-Methylenedioxymethamphetamine (MDMA; "ecstasy") is a popular recreational
drug. The aim of the present study was to explore the role of dopamine in the
psychotropic effects of MDMA using bupropion to inhibit the dopamine and
norepinephrine transporters through which MDMA releases dopamine and
norepinephrine by investigating.
Bupropion in adults with Attention-Deficit/Hyperactivity Disorder: a randomized,
double-blind study. [2014] Attention-Deficit/Hyperactivity Disorder is one of the most common mental
disorders in childhood, and it continues to adulthood without proper treatment. Stimulants have been used in the treatment of Attention-Deficit/Hyperactivity
Disorder (ADHD) for many years, and the efficacy of methylphenidate in the
treatment of adults with ADHD has been proven to be acceptable according to
meta-analysis studies.
Sustained-release bupropion for smoking cessation in a Chinese sample: a
double-blind, placebo-controlled, randomized trial. [2013] population... CONCLUSION: Bup-SR is efficacious for smoking cessation in healthy Chinese
SSRI versus bupropion effects on symptom clusters in suicidal depression: post
hoc analysis of a randomized clinical trial. [2013] CONCLUSIONS: The results require replication but suggest a pathway by which
Bupropion for smoking cessation in patients hospitalized with acute myocardial
infarction: a randomized, placebo-controlled trial. [2013] patients with acute myocardial infarction (AMI)... CONCLUSIONS: Two-thirds of patients return to smoking by 12 months after AMI.
Clinical Trials Related to Wellbutrin SR (Bupropion)
Bupropion Depression [Recruiting]
Determine bioequivalence between branded and generic bupropion extended release (XL)
products (and between generic products) at steady state in patients with major depressive
disorder.
Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder? [Active, not recruiting]
Wellbutrin (bupropion) is an effective antidepressant (Thase, M 2005). It exists in instant
release (IR), sustained release (SR) and extended release (XL) forms. The IR formulation was
never approved for use in Canada. The XL formulation allows for once daily dosing.
Wellbutrin is both a norepinephrine and dopamine reuptake inhibitor, and as such increases
the synaptic concentration of both neurotransmitters. This adds to its positive effects on
cognition, apathy, tiredness and executive functioning. The increased activation may be also
responsible for some of its side effects such as initial insomnia and reduced sleep
efficiency, especially when taken at night.
The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression [Completed]
Many people with depression are treated with a serotonin-specific reuptake inhibitor
anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not
feel completely 'well'. Often, individuals continue to complain of cognitive problems such
as lack of attention, diminished motivation, and impaired problem-solving. This study looks
at whether residual and cognitive symptoms of depression in individuals are affected by the
addition of Wellbutrin (bupropion).
Female Orgasmic Disorder (FOD) and Wellbutrin XL [Completed]
A recently completed multi-site double-blind placebo-controlled study found that bupropion
(Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a
diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain
whether bupropion will improve orgasmic function in pre-menopausal women with a primary
complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder.
This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis
of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug,
and sexual histories will be obtained. Patients who continue to meet screening
inclusion/exclusion criteria at their baseline visit will be randomly assigned to either
placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual
desire and activity will be assessed by patient diaries, investigator interview of sexual
functioning every two weeks, and by standardized questionnaire every four weeks. The
primary endpoint will be the increase in orgasm completion as measured by the Changes in
Sexual Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual
arousal, sexual desire, and sexual pleasure as assessed by the CSFQ-F.
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.
Reports of Suspected Wellbutrin SR (Bupropion) Side Effects
Drug Ineffective (15),
Nausea (14),
Diarrhoea (11),
Headache (9),
Fatigue (9),
Dizziness (9),
Product Quality Issue (9),
Decreased Appetite (8),
Anxiety (8),
Constipation (7), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 11 ratings/reviews, Wellbutrin SR has an overall score of 8.27. The effectiveness score is 8.36 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| Wellbutrin SR review by 45 year old female patient | | Rating |
Overall rating: | |           |
Effectiveness: | | Highly Effective |
Side effects: | | Mild Side Effects | | Treatment Info |
Condition / reason: | | depression |
Dosage & duration: | | 200 mg taken 1x am for the period of 24 months |
Other conditions: | | N/A |
Other drugs taken: | | trazadone | | Reported Results |
Benefits: | | I began to notice the positive benefits within a few weeks. My mood brightened, I stopped feeling grief and self-loathing, began to remember what I liked to do. I also had increased ability to concentrate, increased energy, increased sex drive. I was no longer depressed. I stopped taking the medication after a couple of years, and the symptoms of depression did not return. |
Side effects: | | I actually felt pretty upset during the first couple of weeks - shaky, a little manic and sensitive. That did go away, though. I also had occasional insomnia throughout. |
Comments: | | I met with my physician four weeks after I began taking the medication, then 3 months later, then every six months. I did not attend talk therapy or receive any other treatment. |
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| Wellbutrin SR review by 55 year old female patient | | Rating |
Overall rating: | |           |
Effectiveness: | | Considerably Effective |
Side effects: | | Mild Side Effects | | Treatment Info |
Condition / reason: | | depression |
Dosage & duration: | | 1 per day 150 mg SR taken daily for the period of 7yrs |
Other conditions: | | acid reflux |
Other drugs taken: | | Prilosec; Effexor | | Reported Results |
Benefits: | | It helped with depression and suicidal thoughts. I was able to sleep better and deal with anxiety and stress better. |
Side effects: | | dry mouth was the worst side effect but since I should drink more water anyway it was a mixed blessing. |
Comments: | | Effexor and Wellbutrin kept my depression under control - I took more during the winter months and less the rest of the year. |
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| Wellbutrin SR review by 41 year old female patient | | Rating |
Overall rating: | |           |
Effectiveness: | | Ineffective |
Side effects: | | Moderate Side Effects | | Treatment Info |
Condition / reason: | | depression |
Dosage & duration: | | 150 mg x2 daily taken morning and bight for the period of 3 months |
Other conditions: | | menopausal |
Other drugs taken: | | premarin | | Reported Results |
Benefits: | | i dont think i felt anything positive, no mood change, just the same really although i am smoking a lot less, it does a good job of taking away cravings for nicotine |
Side effects: | | anxiety, anxiety, anxiety |
Comments: | | to take 2 daily, the results are meant to be felt about 1 month after starting treatment |
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Page last updated: 2015-08-10
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