Trial reportDepression and anxiety2015
A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder.
Trial report in Depression and anxiety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01629966 (A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.), which is not on this map. Cited by 19 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
Who cites it
19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Psychological and pharmacological treatments for generalized anxiety disorder (GAD): a meta-analysis of randomized controlled trials.Cognitive behaviour therapy · 2020Pooled it
- Comparing the efficacy of benzodiazepines and serotonergic anti-depressants for adults with generalized anxiety disorder: a meta-analytic review.Expert opinion on pharmacotherapy · 2018Pooled it
- Effects of vilazodone on suicidal ideation and behavior in adults with major depressive disorder or generalized anxiety disorder: post-hoc analysis of randomized, double-blind, placebo-controlled trials.International clinical psychopharmacology · 2017Pooled it
- Effects of vilazodone on sexual functioning in healthy adults: results from a randomized, double-blind, placebo-controlled, and active-controlled study.International clinical psychopharmacology · 2017Trial
- Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone.The primary care companion for CNS disorders · 2016Trial
- Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study.International clinical psychopharmacology · 2015Trial
- Anxiety disorders, PTSD and OCD: systematic review of approved psychiatric medications (2008-2024) and pipeline phase III medications.Drugs in context · 2025Review
- Quantitative investigation of drug-drug interaction between bergenin and vilazodone in rats through UPLC-MS/MS assay.BMC chemistry · 2024Article
- Vilazodone for Major Depression in Adults: Pharmacological Profile and an Updated Review for Clinical Practice.Neuropsychiatric disease and treatment · 2022Review
- Interleukin-4 signalling pathway underlies the anxiolytic effect induced by 3-deoxyadenosine.Psychopharmacology · 2019Article
- Pharmacotherapy for generalized anxiety disorder in adult and pediatric patients: an evidence-based treatment review.Expert opinion on pharmacotherapy · 2018Review
- Anxiety disorders.Nature reviews. Disease primers · 2017Review
- The role of new antidepressants in clinical practice in Canada: a brief review of vortioxetine, levomilnacipran ER, and vilazodone.Neuropsychiatric disease and treatment · 2017Review
- Vilazodone for the Treatment of Depression: An Update.Chonnam medical journal · 2016Review
- The Preclinical and Clinical Effects of Vilazodone for the Treatment of Major Depressive Disorder.Expert opinion on drug discovery · 2016Review
- Characterizing sexual function in patients with generalized anxiety disorder: a pooled analysis of three vilazodone studies.Neuropsychiatric disease and treatment · 2016Article
- INFLUENCE OF STUDY DESIGN ON TREATMENT RESPONSE IN ANXIETY DISORDER CLINICAL TRIALS.Depression and anxiety · 2015Article
- A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Vilazodone in Generalized Social Anxiety Disorder.The primary care companion for CNS disorders · 2015Article
- Evaluation of the efficacy and safety of vilazodone for treating major depressive disorder.Neuropsychiatric disease and treatment · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVilazodone, a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist, is approved for treating major depressive disorder in adults. This study (NCT01629966 ClinicalTrials.gov) evaluated the efficacy and safety of vilazodone in adults with generalized anxiety disorder (GAD).
methodsA multicenter, double-blind, parallel-group, placebo-controlled, fixed-dose study in patients with GAD randomized (1:1:1) to placebo (n = 223), or vilazodone 20 mg/day (n = 230) or 40 mg/day (n = 227). Primary and secondary efficacy parameters were total score change from baseline to week 8 on the Hamilton Rating Scale for Anxiety (HAMA) and Sheehan Disability Scale (SDS), respectively, analyzed using a predefined mixed-effect model for repeated measures (MMRM). Safety outcomes were presented by descriptive statistics.
resultsThe least squares mean difference (95% confidence interval) in HAMA total score change from baseline (MMRM) was statistically significant for vilazodone 40 mg/day versus placebo (-1.80 [-3.26, -0.34]; P = .0312 [adjusted for multiple comparisons]), but not for vilazodone 20 mg/day versus placebo. Mean change from baseline in SDS total score was not significantly different for either dose of vilazodone versus placebo when adjusted for multiplicity; significant improvement versus placebo was noted for vilazodone 40 mg/day without adjustment for multiplicity (P = .0349). The incidence of adverse events was similar for vilazodone 20 and 40 mg/day (∼71%) and slightly lower for placebo (62%). Nausea, diarrhea, dizziness, vomiting, and fatigue were reported in ≥5% of patients in either vilazodone group and at least twice the rate of placebo.
conclusionsVilazodone was effective in treating anxiety symptoms of GAD. No new safety concerns were identified.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.