Efficacy and Safety of Guanfacine Extended-Release in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled Study
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OBJECTIVE: To assess guanfacine extended-release (GXR) efficacy and safety in adults with attention-deficit/hyperactivity disorder (ADHD). METHODS: This phase 3, double-blind, placebo-controlled study (conducted between October 2016 and July 2017) included Japanese patients aged ≥ 18 years with ADHD (DSM-5). Patients received GXR (n = 101) or placebo (n = 100) titrated from 2 mg/d to 4-6 mg/d (dose-optimization; 5 weeks), followed by 4-6 mg/d (dose-maintenance; 5 weeks), then tapered doses to 2 mg/d (2 weeks). Primary endpoint was change from baseline in total score on the Japanese version of the ADHD-Rating Scale IV with adult prompts (ADHD-RS-IV) at week 10. Other measures were ADHD-RS-IV subscales, Clinical Global Impression-Improvement scale (CGI-I) and Patient Global Impression-Improvement scale (PGI-I) (percentage of patients very much improved/much improved), treatment-emergent adverse event (TEAE) incidences, and TEAEs leading to discontinuation. RESULTS: Compared with placebo, there was statistically significantly greater improvement in ADHD-RS-IV total score reduction with GXR (least squares mean ± SE: GXR vs placebo, -11.55 ± 1.10 vs -7.27 ± 1.07; P = .0005; effect size 0.52). There were significantly greater improvements in GXR for ADHD-RS-IV inattention (-7.39 ± 0.79 vs -4.89 ± 0.76; P = .0032) and hyperactivity-impulsivity (-3.84 ± 0.54 vs -2.10 ± 0.52; P = .0021) subscale scores, CGI-I scores (48.1% vs 22.6%; P = .0007), and PGI-I scores (25.3% vs 11.8%; P = .0283). More patients in the GXR versus the placebo group reported TEAEs (81.2% vs 62.0%) and discontinued due to TEAEs (19.8% vs 3.0%). The main TEAEs in the GXR group were somnolence, thirst, blood pressure decrease, nasopharyngitis, postural dizziness, and constipation; most TEAEs were mild to moderate in severity. CONCLUSIONS: In Japanese adults with ADHD, GXR improved ADHD symptoms without any major safety concerns. Trial Registration: Japan Primary Registries Network (https://rctportal.niph.go.jp/en): JapicCTI-163231
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Guanfacine is approved for treating ADHD in USA, Canada, Europe and Japan, the latter in adults as well as children.
“Guanfacine is currently approved for treating ADHD in the USA, Canada, Europe and iJapan, the latter in adults (Iwanami, Saito, Fujiwara, Okutsu, & Ichikawa, 2020) as well as children.”
From Guanfacine’s mechanism of action in treating prefrontal cortical disorders: Successful translation across species (2020) · cites this paper as Iwanami, Saito, Fujiwara, Okutsu, & Ichikawa, 2020
A large Phase 3 trial showed success of guanfacine in adults with ADHD.
“a large Phase 3 Trial showed success in adults (Iwanami et al., 2020)”
From Guanfacine’s mechanism of action in treating prefrontal cortical disorders: Successful translation across species (2020) · cites this paper as Iwanami et al., 2020
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Yamamuro, K., Yamauchi, T., & Makinodan, M. (2026) · Frontiers in Molecular Neuroscience · doi:10.3389/fnmol.2026.1915506
- Authors
- Iwanami, A., Saito, K., Fujiwara, M., Okutsu, D., & Ichikawa, H.
- Affiliations
- SHOWA Medical University (JP)
- Imperial Gift Foundation Boshi-Aiiku-Kai (JP)
- Shionogi (Japan) (JP)
- Corresponding author
- Iwanami, Akira
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2020-04-14
- Volume
- 81
- Issue
- 3
- ISSN
- 0160-6689 (ISSN-L)
- 1555-2101
- OpenAlex
- W3016594565
- Cited by
- 44
- References
- 28
- Citations by year
- 2026: 6 · 2025: 4 · 2024: 11 · 2023: 7 · 2022: 6 · 2021: 6 · 2020: 4
- FWCI
- 4.21
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- guanfacine extended release, attention deficit hyperactivity disorder, adult ADHD, ADHD-RS-IV, inattention, hyperactivity/impulsivity, treatment-emergent adverse events, drug discontinuation, dose titration, treatment efficacy and safety, Japanese patients, CGI-I
- MeSH terms
- Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Attention Deficit Disorder with Hyperactivity, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Guanfacine, Treatment Outcome, Young Adult, Adrenergic alpha-2 Receptor Agonists
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