{"doi":"10.2147/ndt.s242084","title":"&lt;p&gt;Safety and Efficacy of Centanafadine Sustained-Release in Adults With Attention-Deficit Hyperactivity Disorder: Results of Phase 2 Studies&lt;/p&gt;","abstract":"Purpose: Two phase 2 studies evaluated the efficacy and tolerability of centanafadine sustained-release (SR) for adults with attention-deficit/hyperactivity disorder (ADHD). Patients and Methods: In a phase 2a, flexible-dose, single-blind study, 41 male patients (aged 18‒55 years) with a diagnosis of ADHD (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) were titrated with centanafadine-SR 200‒300, 400, or 500 mg/d for 2 weeks, and then were treated with the titrated dose for 2 weeks. In a phase 2b, randomized, double-blind, placebo-controlled, crossover study, 85 male and female patients (aged 18‒60 years) with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) were titrated to target doses of centanafadine-SR 400, 500, 600, or 800 mg/d over the course of 1 week, and then received their titrated dose for 3 weeks. The primary outcome in both studies was mean total ADHD Rating Scale-IV (ADHD-RS-IV) score. Results: In the phase 2a study, mean ADHD-RS-IV total score decreased by 21.41 (standard deviation 10.74) from the start of active centanafadine-SR treatment to the end of week 4 ( P < 0.001). In the phase 2b study, centanafadine-SR treatment resulted in a statistically significant improvement in ADHD-RS-IV from baseline to week 3 compared with placebo (least-squares mean − 16.5 vs − 8.4; P < 0.001; effect size 0.66), with significant efficacy demonstrated as early as week 1. Centanafadine-SR was generally well tolerated at doses ≤ 400 mg. Most treatment-emergent adverse events (TEAEs) were mild or moderate; decreased appetite, headache, and nausea were the most frequently reported. In the 2 studies, 13 of 120 patients discontinued centanafadine-SR due to TEAEs; however, only 1 patient who received ≤ 400 mg discontinued due to a TEAE. No serious TEAEs were reported at any dose. Conclusion: These results support the continued development of centanafadine-SR at doses up to 400 mg/d. Keywords: ADHD Rating Scale-IV, efficacy, norepinephrine-dopamine-serotonin reuptake inhibitor, tolerability","journal":"Neuropsychiatric Disease and Treatment","year":2020,"id":94798,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":37,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.7641,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":472495,"name":"Tim Wigal","orcid":null,"position":1,"is_corresponding":false},{"id":472496,"name":"Mary Hobart","orcid":null,"position":2,"is_corresponding":false},{"id":471756,"name":"Jessica Madera‐McDonough","orcid":"0000-0003-2887-7480","position":3,"is_corresponding":false},{"id":471757,"name":"Ross A. Baker","orcid":"0000-0001-5256-0470","position":4,"is_corresponding":false},{"id":471758,"name":"Eva Kohegyi","orcid":"0000-0003-1480-1362","position":5,"is_corresponding":false},{"id":471759,"name":"Anthony McKinney","orcid":"0000-0001-6401-4661","position":6,"is_corresponding":false},{"id":471760,"name":"Timothy E. Wilens","orcid":"0000-0002-5749-8503","position":7,"is_corresponding":false},{"id":472494,"name":"Sharon B. Wigal","orcid":null,"position":0,"is_corresponding":true}],"reference_count":22,"raw_metadata":null,"created_at":"2026-07-18T22:33:00.770265Z","pmid":"32606695","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}