Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial
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Objective: This is a feasibility study evaluating the safety, tolerability, and potential anxiolytic efficacy of the α 2 agonist guanfacine extended-release (GXR) in children and adolescents with generalized anxiety disorder (GAD), separation anxiety disorder (SAD), or social phobia/social anxiety disorder. Methods: Youth 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. Results: GXR 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. Conclusions: GXR was well tolerated in pediatric subjects with GAD, SAD, and/or social anxiety disorder. ClinicalTrials.gov Identifier: NCT01470469.
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A non-specific anxiolytic effect of guanfacine cannot be excluded.
“A similar clinical picture can be seen in panic attacks, and we cannot exclude a non-specific anxiolytic effect of guanfacine, which has been observed in children and adolescents36 and adults with anxiety complicating cardiac surgery.37”
From Hyperadrenergic Postural Tachycardia Syndrome: Clinical Biomarkers and Response to Guanfacine (2024) · cites this paper as [36]
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Pharmacological screening of a new alpha-2 adrenergic receptor agonist, mafedine, in zebrafish
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Self-citationDiagnosis and Management of Comorbid Anxiety and ADHD in Pediatric Primary Care
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Guanfacine as a Facilitator of Recovery from Conversion Disorder in a Young Girl
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The current state-of-the-art in pharmacotherapy for pediatric generalized anxiety disorder
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Adrenoceptors: A Focus on Psychiatric Disorders and Their Treatments
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Guanfacine-Associated Anxiety in a Child Diagnosed With DMDD and ADHD
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Self-citationCase 2: From anxious to activated: selective serotonin reuptake inhibitor (SSRI)-related activation
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Self-citationCase 7: Struggles in the second grade: attention-deficit hyperactivity disorder (ADHD) in a child
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Self-citationIntegrating Pharmacotherapy into Brief Interventions for Child and Adolescent Treatment
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Prescribing in Children and Adolescents
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Self-citation
- Authors
- Strawn, J. R., Compton, S. N., Robertson, B., Albano, A. M., Hamdani, M., & Rynn, M. A.
- Affiliations
- University of Cincinnati (US)
- Duke University (US)
- Shire (United States) (US)
- New York State Psychiatric Institute (US)
- Morgan Stanley Children's Hospital (US)
- Corresponding author
- Strawn, Jeffrey R.
- Venue
- Journal of Child and Adolescent Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2017-02
- Volume
- 27
- Issue
- 1
- Pages
- 29-37
- ISSN
- 1044-5463 (ISSN-L)
- 1557-8992
- PMC
- PMC5695796
- OpenAlex
- W2593068449
- Cited by
- 55
- References
- 55
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 7 · 2023: 9 · 2022: 6 · 2021: 4 · 2020: 9 · 2019: 4 · 2018: 7 · 2017: 3 · 2016: 1
- FWCI
- 8.19
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Child and Adolescent Psychopharmacology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5k23mh106037-04)
- National Institute of Mental Health (K23-MH106037)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Keywords
- guanfacine extended release, childhood anxiety disorders, generalized anxiety disorder, separation anxiety disorder, social anxiety disorder, alpha-2 adrenergic agonists, drug safety and tolerability, treatment-emergent adverse events, heart rate, blood pressure, CGI-I, SCARED
- MeSH terms
- Phobia, Social, Adolescent, Anxiety Disorders, Anxiety, Separation, Child, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Feasibility Studies, Female, Humans, Male, Pilot Projects, Psychiatric Status Rating Scales, Guanfacine, Treatment Outcome, Adrenergic alpha-2 Receptor Agonists, Suicidal Ideation
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