Evidence map›Paper›PMID 35652746›Full record

Trial reportJournal of clinical psychopharmacology

Efficacy, Safety, and Tolerability of Centanafadine Sustained-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder: Results of 2 Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Trials.

Lenard A Adler, Julie Adams, Jessica Madera-McDonough, Eva Kohegyi, Mary Hobart, Denise Chang, Mark Angelicola, Robert McQuade, Michael Liebowitz

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical psychopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
5.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 38 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Lenard A AdlerFrom the Departments of Psychiatry and Child and Adolescent Psychiatry, NYU Grossman School of Medicine, New York, NY.
Julie AdamsOtsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ.
Jessica Madera-McDonoughOtsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ.
Eva KohegyiOtsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ.
Mary HobartOtsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ.
Denise ChangOtsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ.
Mark AngelicolaOtsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ.
Robert McQuadeOtsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ.
Michael LiebowitzThe Medical Research Network, LLC, New York, NY.
Otsuka (United States) · USNew York University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PURPOSE/

backgroundCentanafadine is an inhibitor of norepinephrine, dopamine, and serotonin reuptake transporters under investigation for the treatment of attention-deficit/hyperactivity disorder (ADHD). METHODS/PROCEDURES: Two phase 3 randomized, double-blind, placebo-controlled, parallel-group studies of 200 mg/d or 400 mg/d centanafadine sustained-release tablets versus placebo included adults (18-55 years of age) with a diagnosis of ADHD. The primary and key secondary efficacy endpoints were the change from baseline at day 42 in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score and the Clinical Global Impression-Severity of Illness Scale, respectively. FINDINGS/

resultsSubjects randomized in study 1 (centanafadine 200 mg/d, n = 149; centanafadine 400 mg/d, n = 149; placebo, n = 148) and study 2 (centanafadine 200 mg/d, n = 145; centanafadine 400 mg/d, n = 143; placebo, n = 142) had moderate to severe ADHD (mean AISRS total score, 38.7 [SD, 6.8] across both studies). At day 42, statistically significant least-squares mean differences in AISRS total score were observed in favor of centanafadine versus placebo in study 1 (200 mg/d: -3.16, P = 0.019; 400 mg/d: -2.74, P = 0.039) and study 2 (200 mg/d: -4.01, P = 0.002; 400 mg/d: -4.47, P = 0.001). Effect sizes versus placebo were -0.28 for 200 mg/d and -0.24 for 400 mg/d in study 1 and -0.37 for 200 mg/d and -0.40 for 400 mg/d in study 2. The overall rate of treatment-emergent adverse events (TEAEs) was low, but there was a small increase in TEAE occurrence with increasing dose. Incidences of serious TEAEs and abuse potential-related AEs were low. IMPLICATIONS/

conclusionsThese are the first large-scale studies to demonstrate the efficacy and safety profiles of 200 mg/d and 400 mg/d centanafadine in adults with ADHD.

Indexed as

Attention Deficit Disorder with HyperactivityCentral Nervous System StimulantsAdultDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodHumansTabletsTreatment OutcomeCentral Nervous System StimulantsDelayed-Action PreparationsTablets

Identifiers

PMID35652746
PMCPMC9426730
OpenAlexW4281998852

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.