Background: Previous meta-analyses of published and unpublished trials indicate that antidepressants provide modest benefits compared to placebo in the treatment of depression; some have argued that these benefits are not clinically significant. However, these meta-analyses were based only on trials submitted for the initial FDA approval of the medication and were limited to those aimed at treating depression. Here, for the first time, we assess the efficacy of a selective serotonin reuptake inhibitor (SSRI) in the treatment of both anxiety and depression, using a complete data set of all published and unpublished trials sponsored by the manufacturer.

Methods And Findings: GlaxoSmithKline has been required to post the results for all sponsored clinical trials online, providing an opportunity to assess the efficacy of an SSRI (paroxetine) with a complete data set of all trials conducted. We examined the data from all placebo-controlled, double-blind trials of paroxetine that included change scores on the Hamilton Rating Scale for Anxiety (HRSA) and/or the Hamilton Rating Scale for Depression (HRSD). For the treatment of anxiety (k = 12), the efficacy difference between paroxetine and placebo was modest (d = 0.27), and independent of baseline severity of anxiety. Overall change in placebo-treated individuals replicated 79% of the magnitude of paroxetine response. Efficacy was superior for the treatment of panic disorder (d = 0.36) than for generalized anxiety disorder (d = 0.20). Published trials showed significantly larger drug-placebo differences than unpublished trials (d's = 0.32 and 0.17, respectively). In depression trials (k = 27), the benefit of paroxetine over placebo was consistent with previous meta-analyses of antidepressant efficacy (d = 0.32).

Conclusions: The available empirical evidence indicates that paroxetine provides only a modest advantage over placebo in treatment of anxiety and depression. Treatment implications are discussed.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4146610PMC
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0106337PLOS

Publication Analysis

Top Keywords

paroxetine placebo
12
anxiety depression
12
hamilton rating
12
unpublished trials
12
treatment anxiety
12
trials
9
previous meta-analyses
8
published unpublished
8
placebo treatment
8
assess efficacy
8

Similar Publications

Objective: To evaluate the efficacy of 2 drug combinations on tinnitus severity and associated stress, depression, sleep, and anxiety.

Study Design: A randomized, double-blind, placebo-controlled clinical trial conducted between 2019 and 2023 for an 8-week duration.

Setting: Single institution tertiary care center.

View Article and Find Full Text PDF

Silexan in anxiety, depression, and related disorders: pharmacological background and clinical data.

Eur Arch Psychiatry Clin Neurosci

October 2024

Neurobiology Laboratory for Brain Aging and Mental Health, Psychiatric University Clinics Basel, Basel, Switzerland.

We present a narrative review of clinical trials investigating the anxiolytic and antidepressant effects of silexan, an active substance derived from lavender oil and summarize nonclinical findings from pharmacological studies supporting its therapeutic use. Six studies investigated the efficacy of the lavender oil in patients with subthreshold and generalized anxiety disorders as well as in mixed anxiety and depressive disorder (MADD). Furthermore, we present data indicating that silexan may influence sleep quality as well as anxiety or depressive disorders in individuals with post-COVID-19.

View Article and Find Full Text PDF

Introduction: Antidepressants may lead to a series of sexual adverse effects (SAEs), among which ejaculation dysfunction (EjD) is often overlooked by clinicians. The purpose of the present network meta-analysis was to assist drug adjustment by comparing and ranking the incidence of EjD among various antidepressants.

Methods: Relevant studies were retrieved from PubMed, Embase, Scopus, Web of Science, ClinicalTrials.

View Article and Find Full Text PDF

Selective serotonin reuptake inhibitors for premenstrual syndrome and premenstrual dysphoric disorder.

Cochrane Database Syst Rev

August 2024

Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

Article Synopsis
  • PMS and PMDD are common conditions affecting women before menstruation, with PMDD being a more severe form, and SSRIs are often used for treatment.
  • A systematic review was conducted to evaluate the benefits and risks of SSRIs in treating these syndromes based on randomized controlled trials.
  • The review updated data collection methods from a 2013 study, analyzing treatment effectiveness and the potential for adverse effects associated with SSRIs.
View Article and Find Full Text PDF
Article Synopsis
  • Several innovative treatments for mental health and neurodegenerative conditions have emerged or are set to be approved, including new antidepressants and drugs targeting PTSD and Alzheimer's disease.
  • The new antidepressant Auvelity combines bupropion and dextromethorphan, enhancing efficacy and tolerability compared to bupropion alone, though its comparison to higher doses of bupropion is still uncertain.
  • Zuranolone, a recent addition for treating postpartum depression, is more convenient than its predecessor brexanolone due to its oral formulation instead of requiring an intravenous infusion.
View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!