Trial · NCT01911442

Lurasidone Pediatric Autism Study

NCT01911442, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2016-02-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lurasidone Pediatric Autism Study. Trials, record NCT01911442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01911442

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Trial

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

Title: Lurasidone Pediatric Autism Study
NCT number: NCT01911442
Status: Completed
Phases: Phase 3
Enrollment: 150 participants, actual
Lead sponsor: Sumitomo Pharma America, Inc.
Conditions: Autism
Interventions: Lurasidone 20 mg daily, Lurasidone, Placebo
First posted: 2013-07-30
Last updated: 2016-02-25
Results first posted: 2016-02-25

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6	Baseline to 6 Weeks	The ABC irritability subscale score is the sum of 15 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC irritability subscale score ranges from 0 to 45. Higher values of ABC subscale scores represent greater severity of illness.
Secondary	Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6	Baseline to 6 Weeks	The Clinical Global Impression - Severity of Illness (CGI-S) Scale is rated on a 7-point scale of severity with 1 = Normal, not at all ill to 7 = Among the most extremely ill patients. Higher values of CGI-S scores represent greater severity of illness.
Secondary	Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6	Baseline to 6 Weeks	The ABC hyperactivity and noncompliance subscale score is the sum of 16 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC hyperactivity and noncompliance subscale score may range from 0 to 48. In general, higher values of ABC subscale scores represent greater severity of illness.
Secondary	Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)	6 Weeks	CY-BOCS total score ranges from 0 to 20. The higher value of CY-BOCS scores the greater severity of illness. This table is a summary of Y-BOCS compulsion total score.
Secondary	Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)	6 Weeks	CGSQ is a caregiver reported assessment to assesses extent to which caregivers are affected by special demands associated with caring for a child with emotional/behavioral problems. CGSQ is comprised of three subscales which range in severity from 1 to 5 (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain), The 3 subscales are calculated as the averages of the corresponding individual items. Higher scores on each indicates greater strain. A Global Strain score is calculated by summing the three subscales (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain) to provide an indication of the total impact of the special demands on the family. Global Strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain.
Secondary	Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6	6 Weeks
Secondary	Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.	6 Weeks

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6	Baseline to 6 Weeks	Intent to treat (ITT) population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6	Baseline to 6 Weeks	Intent to treat population. 49 in the placebo arm is correct. One subject in the placebo group did not receive the study medication, and therefore that subject was removed from the ITT population. A total of 50 subjects were randomized and 49 subjects were included in the placebo group of the ITT population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6	Baseline to 6 Weeks	ITT	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)	6 Weeks	ITT	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)	6 Weeks	ITT	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6	6 Weeks	ITT - the current data presented is at week 6.	percentage of subjects	NUMBER
SECONDARY	Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.	6 Weeks	ITT	percentage of subjects	NUMBER

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Value	Spread	Units
Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6	Lurasidone 20 mg Once Daily	8.8	Standard Error 1.5	units on a scale
Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6	Lurasidone 60 mg Once Daily	9.4	Standard Error 1.43	units on a scale
Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6	Placebo	7.5	Standard Error 1.52	units on a scale
Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6	Lurasidone 20 mg Once Daily	-1.1	Standard Error 0.17	units on a scale
Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6	Lurasidone 60 mg Once Daily	-1.0	Standard Error 0.16	units on a scale
Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6	Placebo	-0.7	Standard Error 0.17	units on a scale
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6	Lurasidone 20 mg Once Daily	-9.7	Standard Error 1.50	units on a scale
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6	Lurasidone 60 mg Once Daily	-6.6	Standard Error 1.43	units on a scale
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6	Placebo	-7.1	Standard Error 1.52	units on a scale
Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)	Lurasidone 20 mg Once Daily	-1.0	Standard Error 0.46	units on a scale

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lurasidone 20 mg Once Daily	49
Overall Study	STARTED	Lurasidone 60 mg Once Daily	51
Overall Study	STARTED	Placebo	50
Overall Study	COMPLETED	Lurasidone 20 mg Once Daily	43
Overall Study	COMPLETED	Lurasidone 60 mg Once Daily	47
Overall Study	COMPLETED	Placebo	38
Overall Study	NOT COMPLETED	Lurasidone 20 mg Once Daily	6
Overall Study	NOT COMPLETED	Lurasidone 60 mg Once Daily	4
Overall Study	NOT COMPLETED	Placebo	12

Source ClinicalTrials.gov

Adverse events93

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	Events
other	Vomiting	Gastrointestinal disorders	Lurasidone 20 mg Once Daily	4	49	4
other	Vomiting	Gastrointestinal disorders	Lurasidone 60 mg Once Daily	14	51	17
other	Vomiting	Gastrointestinal disorders	Placebo	2	49	2
other	Diarrhoea	Gastrointestinal disorders	Lurasidone 20 mg Once Daily	1	49	1
other	Diarrhoea	Gastrointestinal disorders	Lurasidone 60 mg Once Daily	4	51	4
other	Diarrhoea	Gastrointestinal disorders	Placebo	4	49	4
other	Nausea	Gastrointestinal disorders	Lurasidone 20 mg Once Daily	2	49	2
other	Nausea	Gastrointestinal disorders	Lurasidone 60 mg Once Daily	3	51	6
other	Nausea	Gastrointestinal disorders	Placebo	0	49	0
other	Constipation	Gastrointestinal disorders	Lurasidone 20 mg Once Daily	0	49	0

1 to 10 of 93Source ClinicalTrials.gov

See all 93 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lurasidone 20 mg Once Daily
Total, all-cause mortality	Lurasidone 60 mg Once Daily
Total, all-cause mortality	Placebo
Total, other adverse events	Lurasidone 20 mg Once Daily	33	49
Total, other adverse events	Lurasidone 60 mg Once Daily	38	51
Total, other adverse events	Placebo	28	49
Total, serious adverse events	Lurasidone 20 mg Once Daily	3	49
Total, serious adverse events	Lurasidone 60 mg Once Daily	2	51
Total, serious adverse events	Placebo	0	49

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37811711	DERIVED

Source 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.

For software

Read this trial from software.

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