Evidence map›Paper›PMID 27486544›Full record

Trial reportThe primary care companion for CNS disorders2016

Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone.

Arif Khan, Suresh Durgam, Xiongwen Tang, Adam Ruth, Maju Mathews, Carl P Gommoll

3 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The primary care companion for CNS disorders, 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

0 citing papers in PubMed, 6 citations in OpenAlex.

No citing paper in PubMed yet.

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.

Arif KhanNorthwest Clinical Research Center, Bellevue, Washington; Duke University School of Medicine, Department of Psychiatry, Durham, North Carolina.
Suresh DurgamForest Research Institute, an Allergan affiliate, Jersey City, New Jersey.
Xiongwen TangForest Research Institute, an Allergan affiliate, Jersey City, New Jersey.
Adam RuthPrescott Medical Communications Group, Chicago, Illinois.
Maju MathewsForest Research Institute, an Allergan affiliate, Jersey City, New Jersey.
Carl P GommollForest Research Institute, an Allergan affiliate, Jersey City, New Jersey.
Allergan (United States) · USPrescott College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate vilazodone, currently approved for major depressive disorder in adults, for generalized anxiety disorder (GAD).

methodThree randomized, double-blind, placebo-controlled studies showing positive results for vilazodone (2,040 mg/d) in adult patients with GAD (DSM-IV-TR) were pooled for analyses; data were collected from June 2012 to March 2014. Post hoc outcomes in the pooled intent-to-treat population (n = 1,462) included mean change from baseline to week 8 in Hamilton Anxiety Rating Scale (HARS) total score, psychic and somatic anxiety subscale scores, and individual item scores; HARS response (≥ 50% total score improvement) and remission (total score ≤ 7) at week 8; and category shifts, defined as HARS item score ≥ 2 at baseline (moderate to very severe symptoms) and score of 0 at week 8 (no symptoms).

resultsThe least squares mean difference was statistically significant for vilazodone versus placebo in change from baseline to week 8 in HARS total score (-1.83, P < .0001) and in psychic anxiety (-1.21, P < .0001) and somatic anxiety (-0.63, P < .01) subscale scores; differences from placebo were significant on 11 of 14 HARS items (P < .05). Response rates were higher with vilazodone than placebo (48% vs 39%, P < .001), as were remission rates (27% vs 21%, P < .01). The percentage of patients who shifted to no symptoms was significant for vilazodone on several items: anxious mood, tension, intellectual, depressed mood, somatic-muscular, somatic-sensory, cardiovascular, respiratory, and autonomic symptoms (P < .05).

conclusionsTreatment with vilazodone versus placebo was effective in adult GAD patients, with significant differences between treatment groups found on both psychic and somatic HARS items.

trial registrationClinicalTrials.gov identifiers: NCT01629966, NCT01766401, NCT01844115.

Indexed as

AdultAnti-Anxiety AgentsAnxietyAnxiety DisordersDouble-Blind MethodFemaleHumansLeast-Squares AnalysisMalePsychiatric Status Rating ScalesTreatment OutcomeVilazodone HydrochlorideAnti-Anxiety AgentsVilazodone Hydrochloride

Identifiers

PMID27486544
PMCPMC4956429
OpenAlexW2343544161

What OpenQuestion holds

Textmetadata
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.