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Fluoxetine

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5081. Clinical response predictors in a double-blind, placebo-controlled trial of fluoxetine for geriatric major depression. Fluoxetine Collaborative Study Group. (Abstract)

Clinical response predictors in a double-blind, placebo-controlled trial of fluoxetine for geriatric major depression. Fluoxetine Collaborative Study Group. We attempted to determine baseline characteristics predicting response in a 6-week, double-blind, geriatric depression trial, which showed a significantly higher remission rate for fluoxetine (20 mg daily) than for placebo (31.6% vs. 18.6%, p < .001).Outpatients (N = 671) were 60 years or older (mean +/- SD = 67.7 +/- 5.7), met Diagnostic (...) sets) so that potential predictors could be confirmed in a second analysis.Of the 266 variables considered for their prognostic ability, 13 were found to be significant predictors using the development data set, including (a) presence of somatic complaints, absence of agitation, and presence of previous accidental injury for fluoxetine response; and (b) reported feelings of emptiness, absence of somatic complaints, and absence of early insomnia for placebo response. The second analysis using

1995 International psychogeriatrics / IPA Controlled trial quality: uncertain

5082. Long-term fluoxetine treatment of bulimia nervosa. Fluoxetine Bulimia Nervosa Research Group. (Abstract)

Long-term fluoxetine treatment of bulimia nervosa. Fluoxetine Bulimia Nervosa Research Group. A large collaborative 8-week study has shown fluoxetine to be effective and safe in treating patients with bulimia nervosa. The present study evaluated fluoxetine over 16 weeks.Fifteen US out-patient psychiatry clinics conducted a double-blind parallel study in men and women with DSM-III-R bulimia nervosa (483 patients entered, 398 randomised [3:1 ratio, fluoxetine 60 mg/day or placebo], 225 completed (...) ). Outcome measures included change in vomiting and binge-eating episodes per week. Eating Disorder Inventory, Clinical Global Impressions and Patient's Global Impression.Compared with placebo, fluoxetine treatment resulted in significantly greater reductions in vomiting (F[1,360] = 14.73, P < 0.0001) and binge-eating (F[1,360] = 14.39, P = 0.0002) episodes per week at endpoint and improvement in other outcome measures. Adverse event, vital sign and laboratory analyses indicated that fluoxetine

1995 British Journal of Psychiatry Controlled trial quality: uncertain

5083. Benefits from mianserin augmentation of fluoxetine in patients with major depression non-responders to fluoxetine alone. (Abstract)

Benefits from mianserin augmentation of fluoxetine in patients with major depression non-responders to fluoxetine alone. To assess, in depressed patients, the clinical benefit of mianserin augmentation of fluoxetine or the the benefit of switching treatment from fluoxetine to mianserin.In a 6-week double-blind study we compared the therapeutic efficiency and tolerance of mianserin 60 mg/day (N = 34), mianserin 60 mg/day plus fluoxetine 20 mg/day (N = 32) and continuing fluoxetine 20 mg/day (N (...) = 38) in patients with major depression who did not respond to previous fluoxetine treatment.Intent-to-treat analysis showed that at week 6 the decrease in the Hamilton Depression rating scale score was significantly (P < or = 0.03) greater in the mianserin plus fluoxetine group when compared to the fluoxetine group (effect size 0.665). Switching from fluoxetine to mianserin gave intermediate results. Mianserin augmentation of fluoxetine was well tolerated.Mianserin augmentation of fluoxetine

2001 Acta Psychiatrica Scandinavica Controlled trial quality: uncertain

5084. Comparison of the efficacy of fluoxetine alone vs. fluoxetine plus local lidocaine ointment in the treatment of premature ejaculation. (Abstract)

Comparison of the efficacy of fluoxetine alone vs. fluoxetine plus local lidocaine ointment in the treatment of premature ejaculation. The present study compares the efficacy and side effects of fluoxetine alone vs. fluoxetine plus local lidocaine ointment in the treatment of premature ejaculation.Forty-three patients suffering from premature ejaculation were studied. The exclusion criteria were erectile dysfunction, loss of libido, alcohol and substance abuse, mental retardation, diabetes (...) mellitus, thyroid disease, hypotension, previous use of these drugs and urogenital infections. The patients' ages ranged from 19 to 48 years (mean age 28 +/- 1.6). They had regular sexual lives. They had normal psychiatric consultation and the Glombock Rast Sexual Satisfactory Test (GRISS) psychiatric test were in accordance with premature ejaculation.The patients were assigned to two groups. Twenty-six patients, aged 21 to 36 years (mean age 27), received only fluoxetine 20 mg/day (1 capsule

2000 Archivos españoles de urología Controlled trial quality: uncertain

5085. Estrogen replacement and response to fluoxetine in a multicenter geriatric depression trial. Fluoxetine Collaborative Study Group. (Abstract)

Estrogen replacement and response to fluoxetine in a multicenter geriatric depression trial. Fluoxetine Collaborative Study Group. The estrogen decrease of the postmenopausal state may be a factor in both the pathogenesis of late-life depression and in therapeutic response. Studies of nondepressed women over 60 given estrogen replacement therapy (ERT) suggest improvement in mood. The authors compared clinical response of elderly depressed women outpatients entering a 6-week, randomized, placebo (...) -controlled, double-blind, multicenter trial of fluoxetine (20 mg/day); 72 patients received ERT, and 286 did not. There was a significant interaction between ERT status and treatment effect (P = 0.015). Patients on ERT who received fluoxetine had substantially greater mean Ham-D percentage improvement than patients on ERT who received placebo (40.1% vs. 17.0%, respectively); fluoxetine-treated patients not on ERT did not show benefit significantly greater than placebo-treated patients not on ERT. ERT use

1997 The American Journal of Geriatric Psychiatry Controlled trial quality: uncertain

5086. Fluoxetine in the treatment of bulimia nervosa. A multicenter, placebo-controlled, double-blind trial. Fluoxetine Bulimia Nervosa Collaborative Study Group. (Abstract)

Fluoxetine in the treatment of bulimia nervosa. A multicenter, placebo-controlled, double-blind trial. Fluoxetine Bulimia Nervosa Collaborative Study Group. Bulimia nervosa represents a serious public health problem in the United States. We performed an 8-week, double-blind trial comparing fluoxetine hydrochloride (60 and 20 mg/d) with placebo in 387 bulimic women treated on an outpatient basis. Fluoxetine at 60 mg/d proved superior to placebo in decreasing the frequency of weekly binge-eating (...) and vomiting episodes at end point. Fluoxetine at 20 mg/d produced an effect between that of the 60-mg/d dosage and that of placebo. Depression, carbohydrate craving, and pathologic eating attitudes and behaviors also improved significantly with fluoxetine, with the higher dosage again showing a more robust effect than the lower dosage. Several adverse events (ie, insomnia, nausea, asthenia, and tremor) occurred significantly more frequently with fluoxetine (60 or 20 mg/d) than with placebo. However

1992 Archives of general psychiatry Controlled trial quality: uncertain

5087. Continuing treatment of panic disorder after acute response: randomised, placebo-controlled trial with fluoxetine. The Fluoxetine Panic Disorder Study Group. (Abstract)

Continuing treatment of panic disorder after acute response: randomised, placebo-controlled trial with fluoxetine. The Fluoxetine Panic Disorder Study Group. Data concerning appropriate treatment in panic disorder following an initial response to acute therapy are limited.To assess the safety and efficacy of continued fluoxetine treatment following successful acute therapy of panic disorder.Patients who responded to acute fluoxetine treatment were randomised to 24 weeks of continued fluoxetine (...) or placebo.Fluoxetine responders randomised to continue on their acute-phase fluoxetine dose experienced statistically significant improvement in panic attack frequency and phobia rating scale score over 24 weeks of therapy, while those switched to placebo experienced statistically significant worsening in Hamilton Anxiety (HAM-A), Hamilton Depression (HAM-D) and SCL-90-R rating scores.Fluoxetine was associated with improved clinical outcomes compared with placebo during continuation therapy.

1999 British Journal of Psychiatry Controlled trial quality: uncertain

5088. Fluoxetine bioequivalence study: quantification of fluoxetine and norfluoxetine by liquid chromatography coupled to mass spectrometry. (Abstract)

Fluoxetine bioequivalence study: quantification of fluoxetine and norfluoxetine by liquid chromatography coupled to mass spectrometry. In this study, the authors assessed the bioequivalence of two fluoxetine tablet formulations in 24 healthy volunteers of both sexes who received a single 20 mg dose of each fluoxetine formulation, and a new sensitive method for the quantification of fluoxetine and norfluoxetine in human plasma was developed. The study was conducted using an open, randomized, two (...) -period crossover design with a 4-week washout interval. Plasma samples were obtained over a 672-hour period. Plasma fluoxetine and norfluoxetine concentrations were analyzed by combined liquid chromatography coupled to mass spectrometry (LC-MS) with positive ion electrospray ionization using selected ion recording (SIR). Kolmogorov-Smirnov's test, histograms, probit plots, and the correlation between norfluoxetine AUC(0-infinity) and fluoxetine AUC(0-infinity) were used to analyze the population

1999 Journal of clinical pharmacology Controlled trial quality: uncertain

5089. Mirtazapine: efficacy and tolerability in comparison with fluoxetine in patients with moderate to severe major depressive disorder. Mirtazapine-Fluoxetine Study Group. (Abstract)

Mirtazapine: efficacy and tolerability in comparison with fluoxetine in patients with moderate to severe major depressive disorder. Mirtazapine-Fluoxetine Study Group. To compare the efficacy and tolerability of mirtazapine and fluoxetine in depressed inpatients and outpatients.Patients with a major depressive episode (DSM-III-R), a baseline score of > or=21 on the 17-item Hamilton Rating Scale for Depression (HAM-D), and > or=2 on HAM-D Item 1 (depressed mood) were randomly assigned to a 6 (...) -week treatment with either mirtazapine (N=66, 15-60 mg/day) or fluoxetine (N=67, 20-40 mg/day). The upper limit of the mirtazapine dose range was above the dose range approved in the United States (15-45 mg/day). Efficacy was evaluated by the HAM-D, Clinical Global Impressions, the Visual Analogue Mood Rating Scale (VAMRS), and the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ). The efficacy analyses were performed on the intent-to-treat group using the last-observation-carried

1998 Journal of Clinical Psychiatry Controlled trial quality: uncertain

5090. Outcome assessment and clinical improvement in panic disorder: evidence from a randomized controlled trial of fluoxetine and placebo. The Fluoxetine Panic Disorder Study Group. (Abstract)

Outcome assessment and clinical improvement in panic disorder: evidence from a randomized controlled trial of fluoxetine and placebo. The Fluoxetine Panic Disorder Study Group. Although panic attacks account for only a portion of the morbidity of panic disorder and panic attack frequency assessments are unreliable, studies of drug efficacy in panic disorder have generally used reduction in panic attack frequency as the primary measure of improvement. The authors studied the efficacy (...) of fluoxetine treatment in panic disorder and measured the relative contributions of changes in symptoms to overall improvement.Patients with a diagnosis of panic disorder (N = 243) were randomly assigned to treatment with 10 or 20 mg/day of fluoxetine or placebo. Primary outcome measures were change in panic attack frequency and clinician-rated Clinical Global Impression improvement scores. Other assessments included a panic attack inventory, clinician-rated and patient-rated versions of the Panic

1998 American Journal of Psychiatry Controlled trial quality: uncertain

5091. Morning fluoxetine plus evening mianserin versus morning fluoxetine plus evening placebo in the acute treatment of major depression. (Abstract)

Morning fluoxetine plus evening mianserin versus morning fluoxetine plus evening placebo in the acute treatment of major depression. In a randomized clinical study the combination of fluoxetine 20 mg daily and mianserin 30 mg daily was compared to fluoxetine 20 mg daily and a mianserin placebo. In total, 34 patients with major depression were randomized, of whom 16 received fluoxetine plus mianserin; 18 patients received fluoxetine plus placebo. Of these patients, 69% completed the planned (...) trial of six weeks in the fluoxetine plus mianserin group while 61% completed in the fluoxetine plus placebo group. In the efficacy analysis (excluding dropouts from the first two weeks of treatment) the combination of fluoxetine and mianserin was superior to fluoxetine and placebo both in observer ratings of depression and in quality of life ratings. However, in the intention-to-treat analysis this difference was not statistically significant. No major side effects were reported. After four weeks

1998 Pharmacopsychiatry Controlled trial quality: uncertain

5092. A double-blind, placebo-controlled clinical trial of fluoxetine in geriatric patients with major depression. The Fluoxetine Collaborative Study Group. (Abstract)

A double-blind, placebo-controlled clinical trial of fluoxetine in geriatric patients with major depression. The Fluoxetine Collaborative Study Group. Depression in the geriatric population is a frequent, serious, and potentially reversible disorder, yet relatively few blinded, controlled, antidepressant trials have been reported. A number of age related issues complicate safe and effective pharmacotherapy. In a 6-week, double-blind trial in moderately to severely depressed (nonpsychotic (...) ) outpatients over age 60, fluoxetine (N = 335) was statistically significantly more efficacious than placebo (N = 336) in overall response (43.9% vs. 31.6%, p = .002) and remission (31.6% vs. 18.6%, p < .001) rates. Analyses of early discontinuations because of an adverse drug event revealed no statistically significantly greater rate with fluoxetine (n = 39; 11.6) than was seen with placebo (n = 29; 8.6%). These results corroborate that major depression in an older population is responsive

1995 International psychogeriatrics / IPA Controlled trial quality: uncertain

5093. Double-blind study of high-dose fluoxetine versus lithium or desipramine augmentation of fluoxetine in partial responders and nonresponders to fluoxetine. (Abstract)

Double-blind study of high-dose fluoxetine versus lithium or desipramine augmentation of fluoxetine in partial responders and nonresponders to fluoxetine. In a previous study, of 41 depressed patients who had not responded to fluoxetine 20 mg/day, 53% were treated with high-dose fluoxetine (40-60 mg/ day) and responded (i.e., their 17-item Hamilton Rating Scale for Depression [HAM-D-17] score was <7) versus 29% and 25% of patients treated with fluoxetine plus lithium (300-600 mg/day (...) ) or fluoxetine plus desipramine (25-50 mg/day), respectively. We wanted to assess whether these findings could be replicated in a larger sample of depressed outpatients. We identified 101 outpatients with major depressive disorder (52 men and 49 women; mean age, 41.6 + 10.6 years) who were either partial responders (n = 49) or nonresponders (n = 52) to 8 weeks of treatment with fluoxetine 20 mg/ day. These patients were randomized to 4 weeks of double-blind treatment with high-dose fluoxetine (40-60 mg/day

2002 Journal of Clinical Psychopharmacology Controlled trial quality: uncertain

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