Trial · NCT03605836

A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder

NCT03605836, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2021-10-18

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder. Trials, record NCT03605836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03605836

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
NCT number: NCT03605836
Status: Completed
Phases: Phase 3
Enrollment: 590 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
Interventions: Centanafadine SR, Placebo, Centanafadine SR
First posted: 2018-07-30
Last updated: 2021-10-18
Results first posted: 2021-10-18

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) Score at Day 42	Baseline and Day 42	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). Mixed-effect model repeated measure (MMRM) was used for the analysis.
Secondary	Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Day 42	Baseline and Day 42	CGI-S is an observer-rated scale used to measure symptom severity with a total score range of 0 to 7 where 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A negative change from Baseline indicates improvement. MMRM was used for the analysis.
Other	Adverse Event Reporting	Up to 59 days	Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine safety and tolerability of centanafadine SR tablets
Other	ADHD Impact Module - Adult (AIM-A)	Up to 42 days	Scale composed of 3 subscales with a maximum score of 100. A lower score indicates a worse outcome. Exploratory endpoint; comparison of baseline score to other points throughout the study.
Other	Adult ADHD Self Report Scale (ASRS)	Up to 42 days	An 18 question report, total score ranges from 0 to 124. A higher score denotes a worse outcome. Exploratory endpoint; comparison of baseline score to other points throughout the study
Other	AISRS	Up to 42 days	Change from baseline total score compared to every scheduled visit. Each subscale is composed of 9 items each. Scores can range from 0 to 27, with a higher score representing a worse outcome. Change from baseline scores are compared to every scheduled visit score.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) Score at Day 42	Baseline and Day 42	Efficacy Sample FAS includes all participants in the safety sample who had a Baseline value and at least one valid post-randomization efficacy evaluation for AISRS total score in the Double-blind Treatment Period. Overall number analysed are the participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Day 42	Baseline and Day 42	Efficacy sample FAS included all participants in the safety sample who had a Baseline value and at least one valid post-randomization efficacy evaluation for AISRS total score in the Double-blind Treatment Period. Overall number analysed are the participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Adverse Event Reporting	Up to 59 days
OTHER_PRE_SPECIFIED	ADHD Impact Module - Adult (AIM-A)	Up to 42 days
OTHER_PRE_SPECIFIED	Adult ADHD Self Report Scale (ASRS)	Up to 42 days
OTHER_PRE_SPECIFIED	AISRS	Up to 42 days

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) Score at Day 42	Double-blind Treatment Period: Centanafadine SR 200 mg	-12.1	Standard Error 0.96	score on a scale
Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) Score at Day 42	Double-blind Treatment Period: Centanafadine SR 400 mg	-12.5	Standard Error 0.99	score on a scale
Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) Score at Day 42	Double-blind Treatment Period: Placebo	-8.07	Standard Error 0.94	score on a scale
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Day 42	Double-blind Treatment Period: Centanafadine SR 200 mg	-1.04	Standard Error 0.09	score on a scale
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Day 42	Double-blind Treatment Period: Centanafadine SR 400 mg	-0.99	Standard Error 0.09	score on a scale
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Day 42	Double-blind Treatment Period: Placebo	-0.71	Standard Error 0.09	score on a scale

Source ClinicalTrials.gov

Participant flow32

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
OL Placebo Run-in Period [1 Week]	STARTED	Single-blind Run-in Period: Placebo	590
OL Placebo Run-in Period [1 Week]	STARTED	Double-blind Treatment Period: Centanafadine SR 200 mg	0
OL Placebo Run-in Period [1 Week]	STARTED	Double-blind Treatment Period: Centanafadine SR 400 mg	0
OL Placebo Run-in Period [1 Week]	STARTED	Double-blind Treatment Period: Placebo	0
OL Placebo Run-in Period [1 Week]	Treated	Single-blind Run-in Period: Placebo	579
OL Placebo Run-in Period [1 Week]	Treated	Double-blind Treatment Period: Centanafadine SR 200 mg	0
OL Placebo Run-in Period [1 Week]	Treated	Double-blind Treatment Period: Centanafadine SR 400 mg	0
OL Placebo Run-in Period [1 Week]	Treated	Double-blind Treatment Period: Placebo	0
OL Placebo Run-in Period [1 Week]	COMPLETED	Single-blind Run-in Period: Placebo	440
OL Placebo Run-in Period [1 Week]	COMPLETED	Double-blind Treatment Period: Centanafadine SR 200 mg	0

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Placebo: Single-blind Run-in Period Only	0	149
other	Diarrhoea	Gastrointestinal disorders	Placebo + Centanafadine SR 200 mg	4	145
other	Diarrhoea	Gastrointestinal disorders	Placebo + Centanafadine SR 400 mg	8	143
other	Diarrhoea	Gastrointestinal disorders	Placebo + Placebo	3	142
other	Dry Mouth	Gastrointestinal disorders	Placebo: Single-blind Run-in Period Only	1	149
other	Dry Mouth	Gastrointestinal disorders	Placebo + Centanafadine SR 200 mg	3	145
other	Dry Mouth	Gastrointestinal disorders	Placebo + Centanafadine SR 400 mg	9	143
other	Dry Mouth	Gastrointestinal disorders	Placebo + Placebo	1	142
other	Nausea	Gastrointestinal disorders	Placebo: Single-blind Run-in Period Only	3	149
other	Nausea	Gastrointestinal disorders	Placebo + Centanafadine SR 200 mg	5	145

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo: Single-blind Run-in Period Only	0	149
Total, all-cause mortality	Placebo + Centanafadine SR 200 mg	0	145
Total, all-cause mortality	Placebo + Centanafadine SR 400 mg	0	143
Total, all-cause mortality	Placebo + Placebo	0	142
Total, other adverse events	Placebo: Single-blind Run-in Period Only	9	149
Total, other adverse events	Placebo + Centanafadine SR 200 mg	31	145
Total, other adverse events	Placebo + Centanafadine SR 400 mg	47	143
Total, other adverse events	Placebo + Placebo	24	142
Total, serious adverse events	Placebo: Single-blind Run-in Period Only	0	149
Total, serious adverse events	Placebo + Centanafadine SR 200 mg	1	145

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
38824626	DERIVED	PubMed
43010330	DERIVED	PubMed
43010387	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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