Research and Clinical Trials on Bupropion (Amfebutamone, Wellbutrin, Zyban)

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This list of current clinical research trials on Bupropion (Amfebutamone, Wellbutrin, Zyban) is followed by a short set of abstracts from the most recent research articles published on the drug.

Bupropion (Amfebutamone, Wellbutrin, Zyban) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Bupropion (Amfebutamone, Wellbutrin, Zyban).

 

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Current Research Literature on Bupropion (Amfebutamone, Wellbutrin, Zyban)

Here are abstracts for some of the latest research articles to have appeared on Bupropion (Amfebutamone, Wellbutrin, Zyban):

Analysis of nine drugs and their cytochrome P450-specific probe metabolites from urine by liquid chromatography-tandem mass spectrometry utilizing sub 2mum particle size column.

J Chromatogr A. 2008 Nov 7;
Petsalo A, Turpeinen M, Pelkonen O, Tolonen A
An LC/MS/MS method was developed for the analysis of twelve cytochrome P450 (CYP)-specific probe metabolites and their nine parent drugs from human urine. CYP-specific metabolites of melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19 and CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1) and midazolam (CYP3A4) were all analyzed using the same LC/MS/MS method with a single analytical run, either after a one-at-a-time dose or cocktail-type dosing of the parent drugs. Ultra performance liquid chromatography (UPLC) with a 1.7mum particle size column was utilized, providing 1.5-3-fold increase in sensitivity, decrease of analysis time to one third and clearly better chromatographic peak shapes when comparing it with the method using traditional high performance liquid chromatography for the same metabolites. In addition, the method was applied for the analysis of the metabolites from human urine samples collected at multiple time points after single and N-in-one dosing of each of the drugs, showing that the use of both the analytical method and these probe metabolites as CYP-specific markers is feasible in in vivo drug-drug interaction or phenotyping studies.

Comparative Benefits and Harms of Second-Generation Antidepressants: Background Paper for the American College of Physicians.

Ann Intern Med. 2008 Nov 18; 149(10): 734-750
Gartlehner G, Gaynes BN, Hansen RA, Thieda P, Deveaugh-Geiss A, Krebs EE, Moore CG, Morgan L, Lohr KN
BACKGROUND: Second-generation antidepressants dominate the management of major depressive disorder, dysthymia, and subsyndromal depression. Evidence on the comparative benefits and harms is still accruing. PURPOSE: To compare the benefits and harms of second-generation antidepressants (bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, trazodone, and venlafaxine) for the treatment of depressive disorders in adults. DATA SOURCES: MEDLINE, EMBASE, PsychLit, Cochrane Central Register of Controlled Trials, and International Pharmaceutical Abstracts from 1980 to April 2007, limited to English-language articles. Reference lists of pertinent review articles were manually searched and the Center for Drug Evaluation and Research database was explored to identify unpublished research. STUDY SELECTION: Abstracts and full-text articles were independently reviewed by 2 persons. Six previous good- or fair-quality systematic reviews or meta-analyses were included, as were 155 good- or fair-quality double-blind, placebo-controlled, or head-to-head randomized, controlled trials of at least 6 weeks' duration. For harms, 35 observational studies with at least 100 participants and follow-up of at least 12 weeks were also included. DATA EXTRACTION: Using a standard protocol, investigators abstracted data on study design and quality-related details, funding, settings, patients, and outcomes. DATA SYNTHESIS: If data were sufficient, meta-analyses of head-to-head trials were conducted to determine the relative benefit of response to treatment and the weighted mean differences on specific depression rating scales. If sufficient evidence was not available, adjusted indirect comparisons were conducted by using meta-regressions and network meta-analyses. Second-generation antidepressants did not substantially differ in efficacy or effectiveness for the treatment of major depressive disorder on the basis of 203 studies; however, the incidence of specific adverse events and the onset of action differed. The evidence is insufficient to draw conclusions about the comparative efficacy, effectiveness, or harms of these agents for the treatment of dysthymia and subsyndromal depression. Limitation: Adjusted indirect comparisons have methodological limitations and cannot conclusively rule out differences in efficacy. CONCLUSION: Current evidence does not warrant the choice of one second-generation antidepressant over another on the basis of differences in efficacy and effectiveness. Other differences with respect to onset of action and adverse events may be relevant for the choice of a medication.

Using Second-Generation Antidepressants to Treat Depressive Disorders: A Clinical Practice Guideline from the American College of Physicians.

Ann Intern Med. 2008 Nov 18; 149(10): 725-733
Qaseem A, Snow V, Denberg TD, Forciea MA, Owens DK,
Description: The American College of Physicians developed this guideline to present the available evidence on the pharmacologic management of the acute, continuation, and maintenance phases of major depressive disorder; dysthymia; subsyndromal depression; and accompanying symptoms, such as anxiety, insomnia, or neurovegetative symptoms, by using second-generation antidepressants. Methods: Published literature on this topic was identified by using MEDLINE, EMBASE, PsychLit, the Cochrane Central Register of Controlled Trials, and International Pharmaceutical Abstracts from 1980 to April 2007. Searches were limited to English-language studies in adults older than 19 years of age. Keywords for search included terms for depressive disorders and 12 specific second-generation antidepressants-bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, trazodone, and venlafaxine-and their specific trade names. This guideline grades the evidence and recommendations by using the American College of Physicians clinical practice guidelines grading system. Recommendation 1: The American College of Physicians recommends that when clinicians choose pharmacologic therapy to treat patients with acute major depression, they select second-generation antidepressants on the basis of adverse effect profiles, cost, and patient preferences (Grade: strong recommendation; moderate-quality evidence). Recommendation 2: The American College of Physicians recommends that clinicians assess patient status, therapeutic response, and adverse effects of antidepressant therapy on a regular basis beginning within 1 to 2 weeks of initiation of therapy (Grade: strong recommendation; moderate-quality evidence). Recommendation 3: The American College of Physicians recommends that clinicians modify treatment if the patient does not have an adequate response to pharmacotherapy within 6 to 8 weeks of the initiation of therapy for major depressive disorder (Grade: strong recommendation; moderate-quality evidence). Recommendation 4: The American College of Physicians recommends that clinicians continue treatment for 4 to 9 months after a satisfactory response in patients with a first episode of major depressive disorder. For patients who have had 2 or more episodes of depression, an even longer duration of therapy may be beneficial (Grade: strong recommendation; moderate-quality evidence).

[Acute psychosis following bupropion overdosage.]

Ugeskr Laeger. 2008 Nov 10; 170(46): 3777-3778
Hansen MB, Rasmussen KB, Brændholt V
Bupropion is an antidepressant, which in Denmark is only used as an aid for smoking cessation. The toxicological side-effects include insomnia, gastrointestinal symptoms, tachycardia and seizures. A case of intentional overdose in a fourteen-year-old boy is presented. He developed hallucinations and tachycardia after ingesting only 1500 mg of bupropion, but recovered without sequelae.

A controlled trial of bupropion added to nicotine patch and behavioral therapy for smoking cessation in adults with unipolar depressive disorders.

J Clin Psychopharmacol. 2008 Dec; 28(6): 660-6
Evins AE, Culhane MA, Alpert JE, Pava J, Liese BS, Farabaugh A, Fava M
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 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). Adult smokers with current (n = 90) or past (n = 109) UDD were randomly assigned to receive bupropion or placebo added to NRT and CBT for 13 weeks. In the primary analysis, with dropouts considered smokers, 36% (35/97) of those on bupropion and 31% (32/102) on placebo attained biochemically validated 7-day point prevalence abstinence at end of treatment (not significant). Because of a high dropout rate (50%) and a significant difference in abstinence status at dropout by treatment group, a traditional intent-to-treat analysis with last observation carried forward imputation of abstinence status was performed. In this secondary analysis, 56% (54/97) of those on bupropion and 41% (42/102) on placebo met criteria for abstinence at end of trial, chi2 = 4.18, P = 0.04. Nicotine replacement therapy usage and absence of a comorbid anxiety disorder predicted abstinence. Abstinence was associated with increased depressive symptoms, regardless of bupropion treatment. Thus, in the primary analysis, bupropion neither increased the efficacy of intensive group CBT and NRT for smoking cessation in smokers with UDD nor prevented abstinence-associated depressive symptoms. Bupropion seemed to provide an advantage for smoking cessation for those who remained in the trial. The dropout rate was high and was characterized by a higher prevalence of current comorbid anxiety disorder. Given the high abstinence rate achieved with CBT plus NRT, a ceiling effect related to the high level of intervention received by all subjects may have prevented an adequate test of bupropion.

 

This page was last reviewed by Dr Greg Mulhauser, Friday, 4 July 2008.

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