Evidence map›Paper›PMID 28165762›Full record

Trial reportJournal of child and adolescent psychopharmacology2017

Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial.

Jeffrey R Strawn, Scott N Compton, Brigitte Robertson, Anne Marie Albano, Mohamed Hamdani, Moira A Rynn

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of child and adolescent psychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01470469 (A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Tolerability of SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
7.4field-weighted citation impact, top 3% 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.

NCT01470469 phase2completednot on this map

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Tolerability of SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP).

TypeinterventionalSponsorShireRan2012 to 2013Enrolled83ConditionsGeneralized Anxiety Disorder (GAD), Anxiety, Separation, Phobia, SocialArmsSPD503 (extended-release Guanfacine hydrochloride), Placebo
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 citations in OpenAlex.

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  10. Anxiety and dysautonomia symptoms in patients with a NaClinical autonomic research : official journal of the Clinical Autonomic Research Society · 2024
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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 3 institutions in 1 country.

Jeffrey R Strawn1 Anxiety Disorders Research Program, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine , Cincinnati, Ohio.
Scott N Compton2 Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine , Durham, North Carolina.
Brigitte Robertson3 Shire , Lexington, Massachusetts.
Anne Marie Albano4 New York State Psychiatric Institute, Columbia University , New York, New York.
Mohamed Hamdani3 Shire , Lexington, Massachusetts.
Moira A Rynn5 New York Presbyterian Morgan Stanley Children's Hospital, Columbia University/New York State Psychiatric Institute, New York, New York.
Takeda (United States) · USDuke University · USNew York Psychoanalytic Society and Institute · US

Funding

Neurofunctional Predictors of Treatment Response in Adolescents with GADK23MH106037 · NIMH · UNIVERSITY OF CINCINNATI · PI STRAWN, JEFFREY ROBERT · 2014 to 2017
$745k
NIMH NIH HHS K23 MH106037
6 · The paper itself

Abstract

objectiveThis is a feasibility study evaluating the safety, tolerability, and potential anxiolytic efficacy of the α

methodsYouth aged 6-17 years with a primary diagnosis of GAD, SAD, and/or social anxiety disorder were treated with flexibly dosed GXR (1-6 mg daily, n = 62) or placebo (n = 21) for 12 weeks. The primary aim of this study was to determine the safety and tolerability of GXR in youth with anxiety disorders, which involved the analysis of treatment-emergent adverse events (TEAEs), the emergence of suicidal ideation and behaviors, vital signs, and electrocardiographic/laboratory parameters. Exploratory efficacy measures included dimensional anxiety scales (Pediatric Anxiety Rating Scale [PARS] and Screen for Child Anxiety Related Emotional Disorders [SCARED]), as well as the Clinical Global Impression-Improvement (CGI-I) scale. As this was an exploratory study, no inferential statistical analyses were performed.

resultsGXR was safe and well tolerated. Treatment-related mean ± standard deviation changes in heart rate (GXR: 1.8 ± 12 beats per minute [bpm] decrease; placebo: 0.5 ± 11 bpm decrease), systolic blood pressure (GXR: 2.3 ± 11 mm Hg decrease; placebo: 1.7 ± 11 mm Hg decrease), or diastolic blood pressure (GXR: 1.3 ± 9 mm Hg decrease; placebo: 0.9 ± 7 mm Hg increase) were similar between treatment groups. TEAEs, including headache, somnolence/fatigue, abdominal pain, and dizziness, were consistent with the known safety profile of GXR. No differences were observed between treatment groups for PARS and SCARED scores, although at endpoint, a higher proportion of subjects receiving GXR versus placebo demonstrated CGI-I scores ≤2 (54.2% vs. 31.6%), as rated by the clinician investigator.

conclusionsGXR was well tolerated in pediatric subjects with GAD, SAD, and/or social anxiety disorder. ClinicalTrials.gov Identifier: NCT01470469.

Indexed as

AdolescentAdrenergic alpha-2 Receptor AgonistsAnxiety DisordersAnxiety, SeparationChildDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodFeasibility StudiesFemaleGuanfacineHumansMalePhobia, SocialPilot ProjectsPsychiatric Status Rating ScalesAdrenergic alpha-2 Receptor AgonistsDelayed-Action PreparationsGuanfacineadolescentgeneralized anxiety disorderseparation anxiety disordersocial anxiety disordersocial phobiaα2 agonist

Identifiers

PMID28165762
PMCPMC5695796
OpenAlexW2593068449

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.