Wellbutrin (Bupropion Hydrochloride) - Summary

WELLBUTRIN SUMMARY

WELLBUTRIN®
(bupropion hydrochloride)
Tablets

WELLBUTRIN (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 is indicated for the treatment of depression. A physician considering WELLBUTRIN for the management of a patient's first episode of depression should be aware that the drug may cause generalized seizures in a dose-dependent manner with an approximate incidence of 0.4% (4/1,000). This incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted (see WARNINGS).

The efficacy of WELLBUTRIN has been established in 3 placebo-controlled trials, including 2 of approximately 3 weeks' duration in depressed inpatients and one of approximately 6 weeks' duration in depressed outpatients. The depressive disorder of the patients studied corresponds most closely to the Major Depression category of the APA Diagnostic and Statistical Manual III.

Major Depression implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

Effectiveness of WELLBUTRIN in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use WELLBUTRIN 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 (Bupropion)

Does acceptance and relationship focused behavior therapy contribute to bupropion outcomes? A randomized controlled trial of functional analytic psychotherapy and acceptance and commitment therapy for smoking cessation. [2011.12]
This study evaluated a treatment combining bupropion with a novel acceptance and relationship focused behavioral intervention based on the acceptance and relationship context (ARC) model. Three hundred and three smokers from a community sample were randomly assigned to bupropion, a widely used smoking cessation medication, or bupropion plus functional analytic psychotherapy (FAP) and acceptance and commitment therapy (ACT)...

Pilot Randomized Clinical Trial of an SSRI vs Bupropion: Effects on Suicidal Behavior, Ideation, and Mood in Major Depression. [2011.10.12]
Randomized controlled trials in depressed patients selected for elevated suicidal risk are rare... Depressed patients with greater baseline suicidal ideation treated with paroxetine compared with bupropion appeared to experience greater acute improvement in suicidal ideation, after adjusting for global depression.

Neural correlates of antidepressant-related sexual dysfunction: a placebo-controlled FMRI study on healthy males under subchronic paroxetine and bupropion. [2011.08]
Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs) like paroxetine in the treatment of depression, imposing a considerable risk on medication adherence and hence therapeutic success. Bupropion, a norepinephrine and dopamine reuptake inhibitor, is recommended as an alternative treatment without adverse effects concerning sexual arousal and libido...

Varenicline versus Bupropion XL for Smoking Cessation in Older Adolescents: A Randomized, Double-Blind Pilot Trial. [2011.07.20]
INTRODUCTION: Despite tremendous potential public health impact, little work has focused on development of evidence-based smoking cessation treatments for adolescents, including pharmacotherapies... Conclusions: These preliminary results support the feasibility and safety of conducting adequately powered, placebo-controlled efficacy studies of varenicline and bupropion XL for adolescent smoking cessation.

Bupropion and restless legs syndrome: a randomized controlled trial. [2011.07]
INTRODUCTION: Restless legs syndrome (RLS) is a common neurological disorder affecting 10% of the population. Most antidepressants exacerbate symptoms; however, correlational studies have noted symptom improvement with bupropion. The purpose of the current study was to examine whether, in a controlled study, bupropion would improve the symptoms of RLS, or at least not exacerbate them... CONCLUSIONS: The data from our study suggest that bupropion does not exacerbate the symptoms of RLS and may be a reasonable choice if an antidepressant is needed in individuals with RLS. Larger studies that include titration of bupropion should be considered to determine if bupropion is appropriate for primary treatment of RLS, particularly considering the lower cost and favorable side effect profile compared with currently recommended first-line dopamine agonists.

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Clinical Trials Related to Wellbutrin (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.

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.

Study of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation [Recruiting]

Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking? [Recruiting]
The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking.

Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior and a cue reactivity session assessing their reactivity to alcohol-related cues. Subjects are maintained on study medication for 4 weeks after the laboratory session.

The study is subdivided into three studies based on subject population.

Study 1A enrolls heavy drinking smokers (tested under nicotine deprivation). Study 1B enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Study 1C enrolls smokers (not tested under nicotine deprivation) and nonsmokers who meet criteria for alcohol use disorders.

In Study 1A, volunteers are administered either varenicline (Chantix), bupropion (Zyban), or placebo. In Studies 1B and 1C, volunteers are administered either varenicline (Chantix) or placebo.

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PATIENT REVIEWS / RATINGS / COMMENTS

Wellbutrin review by 27 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Depression
Dosage & duration:		300mg / day taken 2x daily for the period of I have been on it for 6 years now
Other conditions:		Inreased sweating at night, mild dehydration, trouble sleeping at times
Other drugs taken:		Celexia
		Reported Results
Benefits:		I began taking the drug to control my Bulimia, which was the main symptom of my depression. It also helped me stop smoking.
Side effects:		Very few. I noticed right away that I had trouble sleeping from my high dosage. My ddoctor then prescribed 40mg / day of Celexia to counteract the restlessness.
Comments:		After about 1 month of taking the drug, the bingeing and purging decreased greatly. (from maybe 4 or 5 times /day to about once a month, if that. After 6 years of being on the medication, my Bulimia is under control and depression seems situational.

Wellbutrin review by 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Bipolar Disorder II
Dosage & duration:		100 mg taken 2x daily for the period of 6 Years
Other conditions:		None
Other drugs taken:		Topomax
		Reported Results
Benefits:		I had a nervous breakdown suddenly and unexpectedly. After 1 week in the psych ward, I was prescribed 2 medications that I soon realized didn't help. Over the course of 1 year, I tried many different combinations of anti-depresants which didn't work. Not until I tried both wellbutrin and topomax together did I start recovering from my breakdown. About 1 1/2 years ago I discontinued the Topomax and I've only used the Wellbutrin since it helps me maintain my health.
Side effects:		I didn't experience any side effects.
Comments:		See above as that thoroughly explains everything.

Wellbutrin review by 37 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Anxety / Depression
Dosage & duration:		150mg taken daily / 150mg in morning for the period of 1 month
Other conditions:		sexual dysfunction
Other drugs taken:		birth control, Hydrochlorothiadzide
		Reported Results
Benefits:		I only started this medication to still treat my Anxiety and mild depression, but eliminate the desire not to want sex.
Side effects:		Irritable, sleeplessness, rages of angry, fatigue, high blood pressure
Comments:		My OBGYN switched me from Prozac to Wellbutrin in efforts to help with the sexual side affects. Well, it did absolulte nothing to help in that area and instead made me more depressed, irritable, had severe rages, crying all the time, no desire to get out of bed, hot flashes and my blood pressure spiked tremendously. I went back to my PCP and I'm back to Zoloft which I had taken in the past and although I'm still having w/d's from the Wellbutrin, I'm felling 80% better in it's only been 3 days. I tossed all the remaining pills out. This drug clearly didn't work for my body. What a horrible experience to go through. I will in the future only get these types of meds from my PCP and not my OBGYN.