Evidence map›Paper›PMID 31043521›Full record

Trial reportScience translational medicine2019

A phase 2 clinical trial of a vasopressin V1a receptor antagonist shows improved adaptive behaviors in men with autism spectrum disorder.

Federico Bolognani, Marta Del Valle Rubido, Lisa Squassante, Christoph Wandel, Michael Derks, Lorraine Murtagh, Jeff Sevigny, Omar Khwaja, Daniel Umbricht, Paulo Fontoura

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Science translational medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 2 pooled it
22.4field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 2 syntheses or guidelines pooled it, 124 citations in OpenAlex.

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  17. Novel therapeutics in autism spectrum disorder.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 2 countries.

Federico BolognaniNeuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Marta Del Valle RubidoNeuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Lisa SquassanteProduct Development, F. Hoffmann-La Roche AG, Basel, Switzerland.
Christoph WandelProduct Development, F. Hoffmann-La Roche AG, Basel, Switzerland.
Michael DerksRoche Pharma Research and Early Development, Roche Innovation Center Welwyn, Roche Products Ltd., Welwyn, UK.
Lorraine MurtaghNeuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Jeff SevignyNeuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.ORCID 0000-0003-0974-6434
Omar KhwajaNeuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Daniel UmbrichtNeuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Paulo FontouraProduct Development, F. Hoffmann-La Roche AG, Basel, Switzerland. paulo.fontoura@roche.com.ORCID 0000-0002-3883-257X
Roche (Switzerland) · CHRoche (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There are no approved pharmacological therapies to address the core symptoms of autism spectrum disorder (ASD), namely, persistent deficits in social communication and social interaction and the presence of restricted, repetitive patterns of behaviors, interests, or activities. The neuropeptide vasopressin has been implicated in the regulation of social behaviors, and its modulation has emerged as a therapeutic target for ASD. The phase 2 VANILLA clinical trial reported here evaluated balovaptan, an orally administered selective vasopressin V1a receptor antagonist, in 223 men with ASD and intelligence quotient ≥70. The drug was administered daily for 12 weeks and was compared with placebo. Participants were randomized to placebo (

Indexed as

Adaptation, PsychologicalAdolescentAdultAntidiuretic Hormone Receptor AntagonistsAutism Spectrum DisorderBehaviorBenzodiazepinesDose-Response Relationship, DrugHumansMaleMiddle AgedPyridinesQuality of LifeReceptors, VasopressinTreatment OutcomeTriazolesAntidiuretic Hormone Receptor AntagonistsAVPR1A protein, humanbalovaptanBenzodiazepinesPyridinesReceptors, VasopressinTriazoles

Identifiers

PMID31043521
OpenAlexW2942769136

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.