Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial.
J Child Adolesc Psychopharmacol
; 27(1): 29-37, 2017 02.
Article
em En
| MEDLINE
| ID: mdl-28165762
ABSTRACT
OBJECTIVE:
This is a feasibility study evaluating the safety, tolerability, and potential anxiolytic efficacy of the α2 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Transtornos de Ansiedade
/
Ansiedade de Separação
/
Guanfacina
/
Fobia Social
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
/
Child
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
J Child Adolesc Psychopharmacol
Assunto da revista:
PEDIATRIA
/
PSICOFARMACOLOGIA
Ano de publicação:
2017
Tipo de documento:
Article