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1.
Biol Psychiatry ; 51(9): 753-61, 2002 May 01.
Article in English | MEDLINE | ID: mdl-11983189

ABSTRACT

BACKGROUND: This was the first controlled continuation phase study (up to 1-year total treatment) to evaluate the safety and efficacy of bupropion SR for decreasing the risk for relapse of depression in patients who responded to bupropion SR. METHODS: Patients with recurrent major depression were treated with bupropion SR 300 mg/day during an 8-week open-label phase. Responders (based on Clinical Global Impressions Scale for Improvement of Illness scores) entered a randomized, double-blind phase where they received bupropion SR 300 mg/day or placebo for up to 44 weeks. After randomization, relapse was defined as the point at which the investigator intervened by withdrawing the patient from the study to treat depression. RESULTS: Four hundred twenty-three patients were randomized. A statistically significant difference in favor of bupropion SR over placebo was seen in the time to treatment intervention for depression when survival curves were compared (log-rank test, p =.003). Statistically significant separation between bupropion SR and placebo began at double-blind week 12 (p <.05). Adverse events in bupropion SR-treated patients accounted for 9% and 4% of discontinuations from the open-label and double-blind phases, respectively. CONCLUSIONS: Bupropion SR was shown to be effective and well tolerated in decreasing the risk for relapse of depression for up to 44 weeks.


Subject(s)
Antidepressive Agents, Second-Generation/adverse effects , Bupropion/adverse effects , Depressive Disorder/drug therapy , Adolescent , Adult , Aged , Double-Blind Method , Female , Humans , Male , Middle Aged , Multicenter Studies as Topic , Risk Factors , Secondary Prevention , Time Factors
2.
J Clin Psychiatry ; 63(4): 357-66, 2002 Apr.
Article in English | MEDLINE | ID: mdl-12000211

ABSTRACT

BACKGROUND: Sexual dysfunction commonly occurs during antidepressant treatment. However, the reported rates of sexual dysfunction vary across antidepressants and are typically underreported in product literature. The objectives of this study were (1) to estimate the prevalence of sexual dysfunction among patients taking newer antidepressants (bupropion immediate release [IR], bupropion sustained release [SR], citalopram, fluoxetine, mirtazapine, nefazodone, paroxetine, sertraline, venlafaxine, and venlafaxine extended release [XR]) and (2) to compare physician-perceived with patient-reported prevalence rates of antidepressant-associated sexual dysfunction. METHOD: This cross-sectional, observational study was conducted in 1101 U.S. primary care clinics. Adult outpatients (4534 women and 1763 men) receiving antidepressant monotherapy were enrolled. The prevalence of sexual dysfunction was measured using the Changes in Sexual Functioning Questionnaire. RESULTS: In the overall population, bupropion IR (22%) and SR (25%) and nefazodone (28%) were associated with the lowest risk for sexual dysfunction, whereas selective serotonin reuptake inhibitor (SSRI) antidepressants, mirtazapine, and venlafaxine XR were associated with higher rates (36%-43%). In a prospectively defined subpopulation unlikely to have predisposing factors for sexual dysfunction, the prevalence of sexual dysfunction ranged from 7% to 30%, with the odds of having sexual dysfunction 4 to 6 times greater with SSRIs or venlafaxine XR than with bupropion SR. Physicians consistently underestimated the prevalence of antidepressant-associated sexual dysfunction. CONCLUSION: Ours is the first study to assess sexual dysfunction across the newer antidepressants using consistent methodology and a validated rating scale. Overall, SSRIs and venlafaxine XR were associated with higher rates of sexual dysfunction than bupropion or nefazodone. Because antidepressant-associated sexual dysfunction is considerably underestimated by physicians, greater recognition and education are imperative when prescribing antidepressant treatment.


Subject(s)
Antidepressive Agents/adverse effects , Depressive Disorder/drug therapy , Sexual Dysfunctions, Psychological/chemically induced , Sexual Dysfunctions, Psychological/epidemiology , Adult , Antidepressive Agents/therapeutic use , Attitude of Health Personnel , Attitude to Health , Cross-Sectional Studies , Cyclohexanols/adverse effects , Cyclohexanols/therapeutic use , Delayed-Action Preparations , Depressive Disorder/psychology , Female , Humans , Logistic Models , Male , Physicians, Family/psychology , Prevalence , Primary Health Care/statistics & numerical data , Prospective Studies , Research Design , Risk Factors , Selective Serotonin Reuptake Inhibitors/adverse effects , Selective Serotonin Reuptake Inhibitors/therapeutic use , Sexual Dysfunctions, Psychological/psychology , United States/epidemiology , Venlafaxine Hydrochloride
3.
Clin Ther ; 24(4): 662-72, 2002 Apr.
Article in English | MEDLINE | ID: mdl-12017410

ABSTRACT

BACKGROUND: Short-term studies have demonstrated a modest weight-reducing to weight-neutral effect among patients receiving bupropion sustained-release (SR) for the treatment of depression. OBJECTIVE: This study was conducted to evaluate the long-term effects of bupropion SR on body weight in patients with depression. METHODS: This analysis was conducted within a long-term relapse-prevention study in patients with major depression. Those whose depression had responded to open-label treatment with bupropion SR were randomized to 44 weeks of double-blind treatment with bupropion SR 300 mg/d or placebo. Patients were categorized by body mass index (BMI) as follows: BMI < 22, BMI 22 to 26, BMI > or = 27, and BMI > or = 30. RESULTS: Four hundred twenty-three patients were enrolled in the double-blind phase of the study, 210 receiving bupropion SR and 213 receiving placebo. At the end of the open-label phase, the following mean weight losses were seen in the 4 BMI groups: BMI < 22, 0.5 kg; BMI 22 to 26, 1.1 kg; and BMI > or = 27 and BMI > or = 30, 1.8 kg each. At the end of double-blind treatment, mean change-from-baseline weights were as follows: BMI < 22, -0.1 kg; BMI 22 to 26, -0.6 kg; BMI > or = 27, -1.4 kg; and BMI > or = 30, -2.4 kg. The rate of change in body weight during the double-blind phase was statistically significant compared with baseline BMI (P < 0.001, analysis of covariance). CONCLUSIONS: Modest mean weight losses that increased with increasing baseline body weight were observed with long-term bupropion SR treatment. The findings of this analysis suggest that bupropion SR may be an appropriate therapeutic option in normal-weight or overweight patients with depression who are concerned about weight gain.


Subject(s)
Antidepressive Agents, Second-Generation/adverse effects , Bupropion/adverse effects , Depressive Disorder/complications , Weight Gain/drug effects , Adolescent , Adult , Aged , Antidepressive Agents, Second-Generation/administration & dosage , Antidepressive Agents, Second-Generation/therapeutic use , Body Mass Index , Bupropion/administration & dosage , Bupropion/therapeutic use , Delayed-Action Preparations , Depressive Disorder/drug therapy , Double-Blind Method , Female , Humans , Male , Middle Aged
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