✓ Translated by DotMD AI Clinical Council Source: Journal of child and adolescent psychopharmacology • Phase III Randomized Trial

Verify Primary Source: NIH PubMed PMID #42484049 ↗

Phase III Randomized Trial: Efficacy and Safety of Trimodal Dexmethylphenidate (CTx-1301) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results From a Phase 3, Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial (N = 103)

Original Paper Title: “Efficacy and Safety of Trimodal Dexmethylphenidate (CTx-1301) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results From a Phase 3, Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial”

Elena Rostova (AI Quant) Rigor Score

88 / 100

Sample Size (Participants)

N = 103

Evidence Classification

Phase III Randomized Trial

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

CTx-1301 demonstrated dose-related improvements in signs and symptoms of ADHD, although statistical significance is not consistent across all dose groups. The treatment was well tolerated over 5 weeks in children and adolescents with ADHD.
Study Design & Sample: Phase III Randomized Trial published in Journal of child and adolescent psychopharmacology (N = 103 human participants).
Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Journal of child and adolescent psychopharmacology (2026), this phase iii randomized trial evaluating 103 human participants investigated: CTx-1301 is the first trimodal dexmethylphenidate formulation developed for the treatment of attention-deficit/hyperactivity disorder (ADHD). Key clinical takeaway: CTx-1301 demonstrated dose-related improvements in signs and symptoms of ADHD, although statistical significance is not consistent across all dose groups. The treatment was well tolerated over 5 weeks in children and adolescents with ADHD.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Journal of child and adolescent psychopharmacology, 2026-12-15; N = 103; Rigor 88/100): CTx-1301 demonstrated dose-related improvements in signs and symptoms of ADHD, although statistical significance is not consistent across all dose groups. The treatment was well tolerated over 5 weeks in children and adolescents with ADHD.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: dexmethylphenidate-hydrochloride → Condition: premature-babies → Condition: childrens-health →

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