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 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 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 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 HIGHLIGHTSMedia Articles Related to Wellbutrin (Bupropion)
Biovail Comments On Proposed Generic Wellbutrin XL(R) Trial Source: Depression News From Medical News Today [2010.01.25] Biovail Corporation (NYSE/TSX: BVF) today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd...
Published Studies Related to Wellbutrin (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 (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 35 ratings/reviews, Wellbutrin has an overall score of 7.37. The effectiveness score is 7.66 and the side effect score is 7.77. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | 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. |
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| | Wellbutrin review by 39 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | | Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 300 mg taken daily for the period of 1 year |
| Other conditions: | | none |
| Other drugs taken: | | none | | | Reported Results |
| Benefits: | | The drug worked on reducing/eliminating my situational feelings of depression. Initially, it increased my energy and focus, and stopped the feelings of sadness. It did not make me feel like a "zombie" and I felt connected to my emotions and the people around me, which I had heard was a side effect of other anti-depressants. |
| Side effects: | | At first I had crazy dreams, whch wasn't so bad. I did not have any trouble falling asleep. I had very high energy for the first 2 weeks, then it tapered off back to normal. I wish the energy had remained. I did not lose any weight, which I was hoping for...but I did not gain any either, so that was positive. |
| Comments: | | I started on 150 mg for 2 weeks on the brand name drug once a day. It seemed like as soon as I was switched to the generic 300mg, the energy and focus benefits stopped. There is no way to know if it was the switch to generic or just my body getting used to the drug, but it was dissapointing. I really enjoyed the energy. I weaned myself off after 1 year because I didn't need it anymore. I did not have any significant withdrawal symptoms. Overall it was a positive experience, although I was glad to not need it anymore. |
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| | Wellbutrin review by 34 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | | Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 75 mg taken once daily for the period of 1 month |
| Other conditions: | | Anxiety |
| Other drugs taken: | | nothing | | | Reported Results |
| Benefits: | | I didn't feel that there were any benefits. I initially started taking Wellbutrin because it was tauted as having little to no sexual side effects. I really was highly disappointed in the overall experience of this drug. I immediately switched back to Effexor. |
| Side effects: | | After a couple of days of taking the drug, I started experiencing severe flash anger. The smallest nuisance would set me off. I remember actually throwing something across my dining room. It was awful. At that point I decided to no longer take the drug. |
| Comments: | | I am not certain what I should describe here. The treatment details were that I was prescribed a medication after having asked for it due to its advertised benefits and I never have been so disappointed in a medicine until this one. I am not certain if other people have had similar experiences or not, but it wasn't pleasant. |
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Page last updated: 2010-01-25
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