Evidence map›Paper›PMID 27382289›Full record

ArticleNeuropsychiatric disease and treatment2016

Characterizing sexual function in patients with generalized anxiety disorder: a pooled analysis of three vilazodone studies.

Anita H Clayton, Suresh Durgam, Xiongwen Tang, Changzheng Chen, Adam Ruth, Carl Gommoll

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Neuropsychiatric disease and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 19% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01629966 phase3completednot on this map

A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.

TypeinterventionalSponsorForest LaboratoriesRan2012 to 2014Enrolled680ConditionsGeneralized Anxiety DisorderArmsPlacebo, Vilazodone
NCT01766401 phase3completednot on this map

A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazadone in Patients With Generalized Anxiety Disorder

TypeinterventionalSponsorForest LaboratoriesRan2013 to 2014Enrolled402ConditionsGeneralized Anxiety DisorderArmsPlacebo, Vilazadone
NCT01844115 phase3completednot on this map

A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.

TypeinterventionalSponsorForest LaboratoriesRan2013 to 2014Enrolled415ConditionsGeneralized Anxiety DisorderArmsPlacebo, Vilazodone
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Anita H ClaytonDepartment of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, VA.
Suresh DurgamForest Research Institute, Jersey City, NJ.
Xiongwen TangForest Research Institute, Jersey City, NJ.
Changzheng ChenForest Research Institute, Jersey City, NJ.
Adam RuthPrescott Medical Communications Group, Chicago, IL, USA.
Carl GommollForest Research Institute, Jersey City, NJ.
Prescott College · USUniversity of Virginia · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVilazodone has been shown to reduce core symptoms of generalized anxiety disorder (GAD) in three randomized, double-blind, placebo-controlled trials. Since sexual dysfunction (SD) is not well characterized in GAD, a post hoc analysis of these trials was conducted to evaluate the effects of vilazodone on sexual functioning in GAD patients. MATERIALS AND

methodsData were pooled from one fixed-dose trial of vilazodone 20 and 40 mg/day (NCT01629966) and two flexible-dose studies of vilazodone 20-40 mg/day (NCT01766401, NCT01844115) in adults with GAD. Sexual functioning was assessed using the Changes in Sexual Functioning Questionnaire (CSFQ). Outcomes included mean change from baseline to end of treatment (EOT) in CSFQ total score and percentage of patients shifting from SD at baseline (CSFQ total score ≤47 for males, ≤41 for females) to normal functioning at EOT. Treatment-emergent adverse events related to sexual functioning were also analyzed.

resultsA total of 1,373 patients were included in the analyses. SD at baseline was more common in females (placebo, 46.4%; vilazodone, 49%) than in males (placebo, 35.1%; vilazodone, 40.9%). CSFQ total score improvement was found in both females (placebo, +1.2; vilazodone, +1.6) and males (placebo, +2.1; vilazodone, +1.0), with no statistically significant differences between treatment groups. The percentage of patients who shifted from SD at baseline to normal sexual functioning at EOT was higher in males (placebo, 40.6%; vilazodone, 35.7%) than in females (placebo, 24.9%; vilazodone, 34.9%); no statistical testing was performed. Except for erectile dysfunction and delayed ejaculation in vilazodone-treated males (2.4% and 2.1%, respectively), no treatment-emergent adverse events related to sexual functioning occurred in ≥2% of patients in either treatment group.

conclusionApproximately 35%-50% of patients in the vilazodone GAD studies had SD at baseline. Vilazodone and placebo had similar effects on CSFQ outcomes in both females and males, indicating a limited adverse impact on sexual functioning with vilazodone.

Indexed as

clinical trialsgeneralized anxiety disorderpost hoc analysissexual dysfunctionvilazodone

Identifiers

PMID27382289
PMCPMC4922821
OpenAlexW2465428371

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.