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Cited by 257Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesPharmacology and Obesity Treatment

Safety and Effectiveness of Coadministration of Guanfacine Extended Release and Psychostimulants in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

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Spencer, Thomas J., Greenbaum, Michael, Ginsberg, Lawrence D., Murphy, William Rory·2009·Journal of Child and Adolescent Psychopharmacology
DOI 10.1089/cap.2008.0152PMC PMC2861960
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Abstract

Objective: The aim of this study was to evaluate the safety and effectiveness of guanfacine extended release (GXR) administered concomitantly with psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) and suboptimal response to a psychostimulant alone. Design and Methods: This was a multicenter, open-label, 9-week, dose-escalation study of 75 subjects with ADHD treated with methylphenidate (MPH) or amphetamine (AMP) alone for at least 1 month, yet with suboptimal control of ADHD symptoms. Sixty-three subjects (84.0%) completed the study. Patients received GXR in addition to their psychostimulant. Starting with 1 mg/day, GXR was increased weekly to the highest tolerated dose (1, 2, 3, or 4 mg/day), which was maintained through week 6. GXR was then titrated downward in 1-mg weekly decrements from week 7 through week 9. Psychostimulant treatment regimens were continued until at least week 7. Main Outcome Measures: Safety assessments included adverse events (AEs), vital signs, physical examination, clinical laboratory tests, the Pediatric Daytime Sleepiness Scale, and the Pittsburgh Side Effects Rating Scale. Efficacy was assessed using the ADHD Rating Scale IV (ADHD-RS-IV), the Conners' Parent Rating Scale–Revised Short Form, Clinical Global Impressions, Parent Global Assessment, and Child Health Questionnaire–Parent Form. Results: The most common treatment-related AEs were upper abdominal pain (25.3%), fatigue (24.0%), irritability (22.7%), headache (20.0%), and somnolence (18.7%). Most AEs were mild to moderate in severity. Investigator-rated AEs due to blood pressure decreases, heart rate, or electrocardiogram findings were infrequent. Mean changes from baseline (psychostimulant monotherapy just prior to receiving GXR) to end point in ADHD-RS-IV total score were statistically significant overall: −16.1 ( p < 0.0001). Significant improvement in both subscales of the ADHD-RS-IV was observed. Improvement of symptoms was observed in a majority of subjects. Conclusion: Coadministration of GXR and MPH or AMP was generally safe and associated with statistically significant and clinically meaningful ADHD symptom improvement in children and adolescents.

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  • Adding clonidine to methylphenidate, extended-release guanfacine to stimulants, or OROS methylphenidate to atomoxetine improved residual ADHD symptoms and was well tolerated.

    “Recent studies have shown that adding clonidine to methylphenidate [95], extended-release guanfacine to stimulants [96], or OROS methylphenidate to atomoxetine [97] improved residual ADHD symptoms and was well tolerated.”

    From Advances in understanding and treating ADHD (2011) · cites this paper as [96]

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Authors
Spencer, T. J., Greenbaum, M., Ginsberg, L. D., & Murphy, W. R.
Affiliations
  • Harvard University (US)
  • Capstone Clinical Research
  • Red Oak Psychiatry Associates
  • Psychiatric Associates
Corresponding author
Spencer, Thomas J.
ORCID
Venue
Journal of Child and Adolescent Psychopharmacology
Publisher
SAGE Publications
Published
2009-10
Volume
19
Issue
5
Pages
501-510
ISSN
  • 1044-5463 (ISSN-L)
  • 1557-8992
DOI
10.1089/cap.2008.0152
PMC
PMC2861960
OpenAlex
W2134421313
Cited by
257
References
30
Citations by year
2026: 3 · 2025: 3 · 2024: 3 · 2023: 2 · 2022: 3 · 2021: 4 · 2020: 159 · 2019: 2 · 2018: 2 · 2017: 4 · 2016: 8 · 2015: 5 · 2014: 14 · 2013: 13 · 2012: 11
FWCI
6.58
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Child and Adolescent Psychopharmacology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Keywords
guanfacine extended release, attention deficit hyperactivity disorder, psychostimulants, methylphenidate, amphetamine, co-administration, dose escalation, adverse events, daytime sleepiness, blood pressure, ADHD symptom improvement, children and adolescents, off-label drug use, alpha-2 adrenergic agonists
MeSH terms
Adolescent, Adrenergic alpha-Agonists, Amphetamine, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Delayed-Action Preparations, Dose-Response Relationship, Drug, Drug Therapy, Combination, Female, Humans, Male, Methylphenidate, Psychiatric Status Rating Scales, Severity of Illness Index, Guanfacine

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