Safety of subchronic treatment with fluoxetine for major depressive disorder in children and adolescents.

Objective: The aim of this study was to assess the safety of subchronic fluoxetine treatment for major depressive disorder (MDD) in children and adolescents.

Methods: Patients received up to 19 weeks of treatment with fluoxetine, 10 mg-60 mg daily. Safety was evaluated through the reporting of concomitant medications, vital signs, routine laboratory testing, electrocardiograms (ECGs), and adverse event data.

Long-term treatment outcomes of depression with associated anxiety: efficacy of continuation treatment with fluoxetine.

Background: Severity of anxiety does not appear to influence the antidepressant response to fluoxetine during acute treatment of major depressive disorder (MDD). We report a retrospective pooled analysis of 2 studies to assess the effect of associated anxiety on the efficacy of fluoxetine in the continuation treatment phase of MDD.

Method: Patients whose MDD remitted (study 1) or responded (study 2) after approximately 12 to 13 weeks of open-label treatment with fluoxetine 20 mg daily were randomly assigned in double-blind fashion to placebo, continued treatment with fluoxetine 20 mg daily, or, in study 2 only, treatment with enteric-coated fluoxetine 90 mg once weekly, for at least 25 weeks.

Recurrence of symptoms of premenstrual dysphoric disorder after the cessation of luteal-phase fluoxetine treatment.

Objective: The aim of this study was to use the data from two clinical trials to evaluate premenstrual dysphoric disorder symptom severity after the discontinuation of fluoxetine treatment.

Study Design: A retrospective analysis of two clinical trials was performed. Patients were treated with fluoxetine or placebo for three cycles, with the use of several different dosing regimens, followed by single blind placebo treatment for one cycle.

Safety and efficacy of fluoxetine in patients who receive oral contraceptive therapy.

Objective: Because many women who receive pharmacologic therapy with antidepressants are also prescribed oral contraceptives, it is important to assess the risk of clinically significant drug interactions. We reviewed the United States fluoxetine clinical trial database, specifically analyzing women ages 18 to 45 years, for differences in safety, antidepressant efficacy, and unplanned pregnancies that were associated with oral contraceptive use.

Study Design: Data from 17 double-blind, placebo-controlled clinical trials in 1698 women were analyzed retrospectively.

Switching patients from daily citalopram, paroxetine, or sertraline to once-weekly fluoxetine in the maintenance of response for depression.

Background: Major depressive disorder is frequently a chronic, recurrent condition necessitating maintenance treatment. For some patients, compliance with daily pharmacotherapy is difficult over time. As an alternative approach, a once-weekly administered formulation of fluoxetine has recently been made available.