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Private practice evaluation of the safety and efficacy of Bupropion ( Wellbutrin SR ) in depressed outpatients.

A multicenter uncontrolled 4-week trial of Bupropion ( Wellbutrin SR ) in depressed outpatients was conducted in the private practices of 25 internists, 9 family practitioners, and 3 psychiatrists. Minimum exclusion criteria were used with respect to concurrent medical ailments, age, and concomitant medications. Of the 380 patients admitted to the study, 325 were included in efficacy analyses, and 359 provided data for safety analyses. The average patient was a 51-year-old married white woman with a high school education and a skilled job. Bupropion ( Wellbutrin SR ) administered in doses of 150-450 mg/day was highly effective in reducing depressive symptomatology as evaluated by the Hamilton Depression and Clinical Global Impressions scales, and the Zung Self-Rating Scale. No clinically significant Bupropion ( Wellbutrin SR )-related changes in blood pressure, pulse rates, respiration rate, body temperature, or laboratory parameters were recorded; only 41 patients were discontinued due to intolerance to adverse experiences. There was a notable absence of daytime sedation, and of anticholinergic and cardiovascular side effects.

Long-term preventive care in depression: the use of Bupropion ( Wellbutrin SR ) in patients intolerant of other antidepressants.

The safety and efficacy of Bupropion ( Wellbutrin SR ) in the preventive care of depression was studied in a long-term open trial. Forty patients from an active general psychiatric practice which emphasizes the treatment of affective disorders have been followed for an average of 336 days (range, 44-791) and seen at least monthly for evaluation with the Hamilton Depression Scale, Zung Self-Rating Scales for Depression and Anxiety, Clinical Global Impression Scale and an adverse reaction report form. One third of the patients had received a diagnosis of bipolar disorder and 50% a diagnosis of recurrent major depressive disorder by DSM-III criteria; all patients were intolerant of tricyclic and other antidepressants. Although several patients were not severely depressed when placed on Bupropion ( Wellbutrin SR ), there was a significant improvement on the Zung Self-Rating Scales. There was a striking reduction in the frequency and intensity of adverse reactions, particularly anticholinergic effects, appetite and weight gain, and sexual dysfunction, compared to tricyclics. Also, there were no cardiovascular changes and no physical, ECG, EEG, or laboratory evidence of toxicity. Bupropion ( Wellbutrin SR ) represents a significant advance in the treatment of depression, particularly for patients who require long-term preventive care and in whom adverse reactions, which might be tolerated in acute treatment, may lead to noncompliance.

High-throughput liquid chromatography-tandem mass spectrometry determination of Bupropion ( Wellbutrin SR ) and its metabolites in human, mouse and rat plasma using a monolithic column.

In the present work, a high-throughput LC/MS/MS method using a Chromolith RP-18 ( [Formula: see text] mm) monolithic column was developed and partially validated for the determination of Bupropion ( Wellbutrin SR ) (BUP), an anti-depressant drug, and its metabolites, hydroxyBupropion ( Wellbutrin SR ) and threo-hydroBupropion ( Wellbutrin SR ) (TB), in human, mouse, and rat plasma. A modern integrated liquid chromatograph and an LC/MS/MS system with a TurboIonSpray (TIS) interface were used for the positive electrospray selected reaction monitoring (SRM) LC/MS analyses. Spiked control plasma calibration standards and quality control (QC) samples were extracted by semi-automated 96-well liquid-liquid extraction (LLE) using ethyl acetate. A mobile phase consisting of 8mM ammonium acetate-acetonitrile (55:45, v/v) delivered isocratically at 5ml/min, and split post-column to 2ml/min directed to the TIS, provided the optimum conditions for the chromatographic separation of Bupropion ( Wellbutrin SR ) and its metabolites within 23s. The isotope-labeled D(6)-Bupropion ( Wellbutrin SR ) and D(6)-hydroxyBupropion ( Wellbutrin SR ) were used as internal standards. The method was linear over a concentration range of 0.25-200ng/ml (Bupropion ( Wellbutrin SR ) and threo-hydroBupropion ( Wellbutrin SR )), and 1.25-1000ng/ml (hydroxyBupropion ( Wellbutrin SR )). The intra- and inter-day assay accuracy and precision were within 15% for all analytes in each of the biological matrices. The monolithic column performance as a function of column backpressure, peak asymmetry, and retention time reproducibility was adequately maintained over 864 extracted plasma injections.

 

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