Poster
1596317
A Phase 3, safety and efficacy, adult laboratory classroom study in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) using CTx-1301 (dexmethylphenidate).
Psych Congress 2023
This work was sponsored by Cingulate Therapeutics, LLC
Purpose:
To evaluate the safety and efficacy of CTx-1301 in adults with ADHD in a laboratory classroom setting. This study assessed the onset and duration of effect by evaluating PERMP scores.
Methods:
This is a single-center, dose-optimized, randomized, double-blind, placebo-controlled, laboratory classroom study. Safety and efficacy were assessed using the AISRS, PERMP, CGI and MINI scales. The study was comprised of a 45-day screening period, 5-week dose-optimization phase, 7-day double-blind, randomized, efficacy phase, and a safety follow-up visit.
Results:
Forty-eight patients were screened, 26 were enrolled and 21 completed the study. 11 subjects received the CTx-1301 and 10 received placebo. Subjects who were randomized to their optimized dose of CTx-1301 showed improvements on the PERMP scores (effect size 0.88 to 2.6; average of 1.79) compared to subjects randomized to placebo. CTx-1301 subjects demonstrated an effect size of 1.41 at 30 minutes and 0.98 at 16 hours; corresponding to and duration of effect. During the randomized phase, CGI scale demonstrated a statistical significant change in severity of illness for CTx-1301 (-1.1) vs placebo (0.0), (p
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