Primary: To evaluate the efficacy of CTN in adults ages with ADHD and comorbid anxiety (AISRS) Key Secondary: To assess the efficacy of CTN in adults ages with ADHD and comorbid anxiety

P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety

ADHD

ADD / ADHD

Anxiety

Generalized Anxiety

Social Anxiety Disorder

Placebo

Centanafadine

A Phase 3b, Randomized, Double-blind, 8-week, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Centanafadine Once Daily Extended-release Capsules for the Treatment of Adults With Attention-deficit/Hyperactivity Disorder and Comorbid Anxiety

The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement.

The HAM-A consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a 5-point scale, ranging from 0 = not present to 4 = very severe. Negative change from Baseline indicates improvement.

Primary: To evaluate the efficacy of CTN in adults ages with ADHD and comorbid anxiety
(AISRS) Key Secondary: To assess the efficacy of CTN in adults ages with ADHD and
comorbid anxiety

Clinical Research Site #017 - Harmonex Neuroscience Research

Clinical Research Center #033 - Woodland International Research Group

Clinical Research Center #048 - Woodland Research Northwest

Clinical Research Site #052 - Leading Edge Research LA, LLC

Clinical Research Center #008 - Long Beach Clinical Trial Services Inc.

Clinical Research Site #008 - Long Beach Clinical Trial Services Inc.

Clinical Research Site #011 - NRC Research Institute

Clinical Research Center #042 - Anderson Clinical Research

Clinical Research Site #037 - Cenexel CIT IE (Clinical Innovations Inc)

Clinical Research Site #039 - California Neuroscience Research, LLC

Clinical Research Site #038 - Sunwise Clinical Research

Clinical Research Site #030 - MCB Clinical Research Centers

Clinical Research Site #045 - Research Center for Clinical Studies

Clinical Research Center #035 - Sarkis Clinical Trials

Clinical Research Site #005 - Clinical Neuroscience Solutions, Inc.

Clinical Research Site #046 - ARSN-Largo CRU

Clinical Research Site #010 - Meridien Research/Accel Clinical

Clinical Research Site #015 - Medical Research Group of Central Florida

Clinical Research Site #006 - CNS Healthcare Orlando

Clinical Research Site #019 - Segal Trials Innovatice Clinical Research, Inc.

Clinical Research Site #004 - CenExel iResearch, LLC

Clinical Research Site #002 - Psych Atlanta, PC

Clinical Research Center #032 - CenExel iResearch, LLC

Clinical Research Center #056 - Research Works INC.

Clinical Research Site # 027 - Copley Clinical

Clinical Research Center #022 - Boston Clinical Trials - Alcanza Clinical Research, LLC

Clinical Research Site #025 - Adams Clinical

Clinical Research Site #016 - Clinical Research of Southern Nevada, LLC

Clinical Research Center #031 - Center for Emotional Fitness

Clinical Research Site #026 - Neurobehavioral Research Inc

Clinical Research Site #021 - The Medical Research Network, LLC

Clinical Research Site #028 - Patient Priority Clinical Sites LLC

Clinical Research Site #047 - Insight Clinical Trials

Clinical Research Site #009 - Paradigm Research Professionals LLC

Clinical Research Site #023 - Summit Headlands LLC

Clinical Research Site # 029 - Lehigh Center for Clinical Research

Clinical Research Site #014 - Suburban Research Associates

Clinical Research Center #059 - Adams Clinical Philadelphia

Clinical Research Center #034 - Coastal Carolina Research Center

Clinical Research Site #001 - CNS Healthcare - Memphis

Clinical Research Site #013 - Donald J. Garcia, Jr. MD., PA

Clinical Research Site #020 - Houston Clinical Trials LLC

Clinical Research Site #003 - FutureSearch Trials of Dallas LP

Clinical Research Site #012 - Clinical Trials of Texas

Clinical Research Site #036 - Grayline Research Center

Clinical Research Site #024 - Core Clinical Research

Clinical Research Center #062 - Research Works - San Juan

The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a
scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54
(extremely severe ADHD symptoms). Negative change from Baseline indicates improvement.

The HAM-A consists of 14 items, each defined by a series of symptoms, and measures both
psychic anxiety (mental agitation and psychological distress) and somatic anxiety
(physical complaints related to anxiety). Each item is scored on a 5-point scale, ranging
from 0 = not present to 4 = very severe. Negative change from Baseline indicates
improvement.

Trial at a glance

Trial results

P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety

CT.gov ID:

Summary

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