Safety of Flibanserin in Women Treated With Antidepressants: A Randomized, Placebo-Controlled Study.

Background: Depression is often associated with sexual dysfunction, and pharmacologic treatment for hypoactive sexual desire disorder can be considered in women receiving treatment for depression.

Aim: To evaluate the safety of flibanserin in women treated for depression with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

Methods: In this double-blinded, randomized, placebo-controlled trial, women with remitted or mild depression treated with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors who were not postmenopausal and were experiencing symptoms of hypoactive sexual desire disorder (ie, decreased sexual desire and related distress) received flibanserin 50 mg at bedtime (qhs) for 2 weeks and up-titrated to 100 mg qhs, flibanserin 100 mg qhs for the entire treatment period, or placebo for up to 12 weeks.

Understanding the Role of Serotonin in Female Hypoactive Sexual Desire Disorder and Treatment Options.

Background: The neurobiology of sexual response is driven in part by dopamine and serotonin-the former modulating excitatory pathways and the latter regulating inhibitory pathways. Neurobiological underpinnings of hypoactive sexual desire disorder (HSDD) are seemingly related to overactive serotonin activity that results in underactive dopamine activity. As such, pharmacologic agents that decrease serotonin, increase dopamine, or some combination thereof, have therapeutic potential for HSDD.

Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial.

Introduction: Vilazodone is a potent serotonin (5-HT) reuptake inhibitor and 5-HT₁A receptor partial agonist approved by the US Food and Drug Administration for the treatment of major depressive disorder (MDD) in adults. This study evaluated the efficacy and tolerability of vilazodone in the treatment of MDD.

Method: This 8-week, randomized (1:1), double-blind, placebo-controlled, parallel-group, fixed-dose study conducted from January 2012 to February 2013 compared vilazodone 40 mg/d with placebo in outpatients with DSM-IV-TR-diagnosed MDD.

Antidepressants and sexual dysfunction: mechanisms and clinical implications.

Introduction: Depression is one of the more prevalent mental disorders in the United States, with estimates as high as 6.7% of Americans affected annually. Consequently, antidepressant use in the United States is also widespread.

The Safety and Tolerability Profile of Vilazodone, A Novel Antidepressant for the Treatment of Major Depressive Disorder.

Objective: Vilazodone is a selective serotonin reuptake inhibitor and 5-HT receptor partial agonist approved for the treatment of major depressive disorder (MDD). This report summarizes the safety and tolerability of vilazodone 40 mg/day during short- and long-term treatment of adult MDD.

Methods: Pooled data from two 8-week, double-blind studies of vilazodone (n = 436) vs placebo (n = 433) and data from one 52-week, open-label study (n = 616, vilazodone only) were analyzed.

Changes in total body bone mineral density following a common bone health plan with two versions of a unique bone health supplement: a comparative effectiveness research study.

Background: The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans that: (1) improve nutrition, (2) increase health literacy and, (3) increase physical activity. This study is a response to this call to action.

Methods: After signing an informed consent, 158 adults agreed to follow an open-label bone-health plan for six months after taking a DXA test of bone density, a 43-chemistry blood test panel and a quality of life inventory (AlgaeCal 1).

A comparative effectiveness study of bone density changes in women over 40 following three bone health plans containing variations of the same novel plant-sourced calcium.

Background: The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans incorporating components of (1) improved nutrition, (2) increased health literacy, and (3) increased physical activity.

Objective: To conduct a Comparative Effectiveness Research (CER) study comparing changes in bone mineral density in healthy women over-40 with above-average compliance when following one of three bone health Plans incorporating the SG's three components.

Methods: Using an open-label sequential design, 414 females over 40 years of age were tested, 176 of whom agreed to participate and follow one of three different bone-health programs.

Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study.

Objective: To investigate the efficacy, safety, and clinical benefit of a once-daily formulation of trazodone (Trazodone Contramid((c)) OAD) in the treatment of major depressive disorder.

Design/participants: In this double-blind study, 412 patients with major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) were randomized 1:1 to receive either Trazodone Contramid OAD (150 to 375mg) or placebo. Treatment was titrated over two weeks to each individual optimal dose.

Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial.

Context: Antidepressant-associated sexual dysfunction is a common adverse effect that frequently results in premature medication treatment discontinuation and for which no treatment has demonstrated efficacy in women.

Objective: To evaluate the efficacy of sildenafil for sexual dysfunction associated with selective and nonselective serotonin reuptake inhibitors (SRIs) in women.

Design, Setting, And Participants: An 8-week prospective, parallel-group, randomized, double-blind, placebo-controlled clinical trial conducted between September 1, 2003, and January 1, 2007, at 7 US research centers that included 98 previously sexually functioning, premenopausal women (mean [SD] age 37.

Physician handling of prescription stimulants.

Good medical practices can significantly reduce the possibility of diversion and misuse of the stimulants commonly prescribed to treat ADHD. While the problems of misuse and abuse are real, they should not become a barrier to appropriate use of these medicines, which are safe and effective for the large majority of patients with ADHD using them. With appropriate care, physicians treating patients with ADHD can be confident that their treatments are safe, not only for the patients they treat, but also for the communities in which they live.

Comparison of androgens in women with hypoactive sexual desire disorder: those on combined oral contraceptives (COCs) vs. those not on COCs.

Introduction: Approximately one out of four sexually active women in the United States uses some form of hormonal contraceptive method because they provide the most effective reversible method of birth control available. However, little attention has been paid to possible adverse effects of combined oral contraceptives (COCs) on sexual functioning.

Aim: The aim of this study was to examine the potential effects of COCs on women with hypoactive sexual desire disorder (HSDD).

Bupropion extended release compared with escitalopram: effects on sexual functioning and antidepressant efficacy in 2 randomized, double-blind, placebo-controlled studies.

Objective: To compare the effects on sexual functioning and the antidepressant efficacy of once-daily bupropion extended release (XL) and escitalopram in adults with major depressive disorder (MDD).

Method: Adult outpatients with moderate to severe DSM-IV-defined MDD and normal sexual functioning were randomly assigned to receive bupropion XL (300-450 mg/day; N = 276), escitalopram (10-20 mg/day; N = 281), or placebo (N = 273) for up to 8 weeks in 2 identically designed, randomized, double-blind, parallel-group studies (study 1 conducted from February 6, 2003, to June 10, 2004; study 2 conducted from January 21, 2003, to June 15, 2004). Data were analyzed prospectively for each study individually, and pooled data were analyzed retrospectively.

Bupropion sustained release for the treatment of hypoactive sexual desire disorder in premenopausal women.

Premenopausal women meeting operational criteria for idiopathic, acquired, global hypoactive sexual desire disorder were studied in a randomized, double-blind, placebo-controlled, multiple-site escalating dose 112-day trial of bupropion sustained release. Outcome was measured by investigator-rating and self-administered questionnaires. All measures indicated greater sexual responsiveness in women receiving bupropion.

Antidepressant-related erectile dysfunction: management via avoidance, switching antidepressants, antidotes, and adaptation.

The ideal antidepressant would control depression with no adverse effect on sexual function. Erectile dysfunction and other sexual dysfunction associated with antidepressant medication treatment are problems with many antidepressants and can lead to patient dissatisfaction and decreased compliance with treatment. A computerized MEDLINE search (English language, 1966-2003) was performed using the terms antidepressive agents, erectile dysfunction, and sexual dysfunction.

Effect on body weight of bupropion sustained-release in patients with major depression treated for 52 weeks.

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.

Prevalence of sexual dysfunction among newer antidepressants.

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.

Sexual history taking.

Including in the routine medical history some basic questions regarding sexual functioning can help to identify persons with sexual problems and to encourage future dialogue. The first step in counseling is to obtain a history of the patient's specific complaint. The aim is to collect pertinent information while creating a climate in which to discuss sexual problems.