Trial · NCT02046369

Lurasidone Pediatric Bipolar Study

NCT02046369, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2017-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lurasidone Pediatric Bipolar Study. Trials, record NCT02046369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02046369

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Trial

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

Title: Lurasidone Pediatric Bipolar Study
NCT number: NCT02046369
Status: Completed
Phases: Phase 3
Enrollment: 350 participants, actual
Lead sponsor: Sumitomo Pharma America, Inc.
Conditions: Bipolar I Depression
Interventions: Lurasidone, Placebo
First posted: 2014-01-27
Last updated: 2017-12-20
Other registries' IDs: eudract:2013-004903-37
Results first posted: 2017-12-20

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline	baseline, Week 6	CDRS-R total score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness. The primary efficacy endpoint will be assessed between the placebo and treatment group.
Secondary	Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.	baseline and week 6	PARS score: changes from baseline over time - mixed model for repeated measures-LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The PARS is a clinician-rated instrument for assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety disorders in children ages 6-17 years. The PARS is administered separately to the subject and to the caregiver. The instrument has 2 sections. The first section includes a 50-item symptom checklist, which the clinician rates as present or absent during the past week. The second section is comprised of 7 severity impairment items reflecting the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during the past week). Each question is answered on a 0-5 Likert scale (0 for none, and 1-5 for minimal to extreme) with alternative responses of 8=Not Applicable and 9=Does Not Know. The PAR total score over all 7 questions ranges in value from 0 to 35.
Secondary	Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.	baseline	PQ-LES-Q percentage maximum possible score: changes from baseline over time - mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures
Secondary	Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score as Compared to Placebo.	baseline and week 6	CGAS Score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures
Secondary	Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.	baseline and week 6	ADHD-RS total score: changes from baseline over time -ANCOVA-LS Mean and SE for change from baseline are based on ANCOVA. The Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score),where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.
Secondary	Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score	baseline and week 6	Change from baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) depression score changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The CGI-BP-S is a three-question clinician-rated assessment of the subject's current illness state (depression, mania, and overall) using a 7-point scale (1(normal, not ill) to 7 (very severely ill)) for each question, where a higher score is associated with greater illness severity.

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 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline	baseline, Week 6	The ITT population includes all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.	baseline and week 6	The ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.	baseline	the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment on any efficacy variable	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score as Compared to Placebo.	baseline and week 6	the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.	baseline and week 6	The ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score	baseline and week 6	the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Spread	Units
Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline	Luradisone	baseline	59.2	Standard Deviation 8.24	units on a scale
Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline	Placebo	baseline	58.6	Standard Deviation 8.26	units on a scale
Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline	Luradisone	week 6	-21.0	Standard Deviation 1.06	units on a scale
Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline	Placebo	week 6	-15.3	Standard Deviation 1.08	units on a scale
Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.	Luradisone	baseline	10.9	Standard Deviation 7.72	units on a scale
Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.	Placebo	baseline	11.5	Standard Deviation 7.60	units on a scale
Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.	Luradisone	week 6	-3.4	Standard Deviation 0.44	units on a scale
Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.	Placebo	week 6	-2.3	Standard Deviation 0.45	units on a scale
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.	Luradisone	baseline	49.6	Standard Deviation 15.49	units on a scale
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.	Placebo	baseline	49.7	Standard Deviation 17.31	units on a scale

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Luradisone	176
Overall Study	STARTED	Placebo	174
Overall Study	COMPLETED	Luradisone	162
Overall Study	COMPLETED	Placebo	156
Overall Study	NOT COMPLETED	Luradisone	14
Overall Study	NOT COMPLETED	Placebo	18

Source ClinicalTrials.gov

Adverse events26

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	headache	Nervous system disorders	Luradisone	25	175	30
other	headache	Nervous system disorders	Placebo	26	172	38
other	somnolence	Nervous system disorders	Luradisone	16	175	20
other	somnolence	Nervous system disorders	Placebo	8	172	9
other	dizziness	Nervous system disorders	Luradisone	10	175	12
other	dizziness	Nervous system disorders	Placebo	8	172	8
other	nausea	Gastrointestinal disorders	Luradisone	28	175	35
other	nausea	Gastrointestinal disorders	Placebo	10	172	13
other	vomiting	Gastrointestinal disorders	Luradisone	11	175	15
other	vomiting	Gastrointestinal disorders	Placebo	6	172	8

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Luradisone
Total, all-cause mortality	Placebo
Total, other adverse events	Luradisone	112	175
Total, other adverse events	Placebo	75	172
Total, serious adverse events	Luradisone	2	175
Total, serious adverse events	Placebo	4	172

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29173735	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 comparisons1

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

Comparison
Luradisone vs Placebo: serious adverse events

Source Trial comparisons

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.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02046369

GET https://conductscience.org/api/trials/v1/NCT02046369/results?page=2

API reference For AI assistants