Evidence map›Paper›PMID 32606695›Full record

Trial reportNeuropsychiatric disease and treatment2020

Safety and Efficacy of Centanafadine Sustained-Release in Adults With Attention-Deficit Hyperactivity Disorder: Results of Phase 2 Studies.

Sharon B Wigal, Tim Wigal, Mary Hobart, Jessica J Madera, Ross A Baker, Eva Kohegyi, Anthony McKinney, Timothy E Wilens

Open access · goldAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Neuropsychiatric disease and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.4field-weighted citation impact, top 11% 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

15 citing papers in PubMed, 34 citations in OpenAlex.

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  13. Dopamine, Immunity, and Disease.Pharmacological reviews · 2023
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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

8 authors at 3 institutions in 1 country.

Sharon B WigalAVIDA Inc., Newport Beach, California, USA.
Tim WigalAVIDA Inc., Newport Beach, California, USA.
Mary HobartOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.
Jessica J MaderaOtsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA.
Ross A BakerOtsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA.ORCID 0000-0001-5256-0470
Eva KohegyiOtsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA.ORCID 0000-0003-1480-1362
Anthony McKinneyEthismos Research, Inc, Cambridge, Massachusetts, USA.ORCID 0000-0001-6401-4661
Timothy E WilensMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Otsuka (United States) · USHarvard University · USPharmaceutical Product Development (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTwo phase 2 studies evaluated the efficacy and tolerability of centanafadine sustained-release (SR) for adults with attention-deficit/hyperactivity disorder (ADHD). PATIENTS AND

methodsIn 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.

resultsIn 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 (

conclusionThese results support the continued development of centanafadine-SR at doses up to 400 mg/d.

Indexed as

ADHD Rating Scale-IVefficacynorepinephrine-dopamine-serotonin reuptake inhibitortolerability

Identifiers

PMID32606695
PMCPMC7292254
OpenAlexW3033192775

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.