Trial · NCT01914393
Pediatric Open-Label Extension Study
NCT01914393, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2019-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pediatric Open-Label Extension Study. Trials, record NCT01914393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01914393
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pediatric Open-Label Extension Study
- NCT number
- NCT01914393
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 702 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Schizophrenia, Autism, Bipolar Depression
- Interventions
- Lurasidone 20, 40, 60, 80 mg, flexibly dosed
- First posted
- 2013-08-02
- Last updated
- 2019-12-19
- Other registries' IDs
- eudract:2013-001694-24
- Results first posted
- 2019-12-19
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | During 104 Weeks (2-years) treatment period | The Safety population consists of all subjects who received at least one dose of study drug in this study. |
| Secondary | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score for subjects continued from study D1050301. PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210 Higher values of PANSS total score represents greater severity of illness. |
| Secondary | Change From Baseline in PANSS Positive Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | Change from Baseline in PANSS Positive Subscale Score for subjects continued from study D1050301 The Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness /persecution, and hostility; Positive subscale (range 7-49) is calculated as sum of Items P1 to P7 in the positive subscale Higher values of PANSS sub-scale scores represent greater severity |
| Secondary | Change From Baseline in PANSS Negative Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | Change from Baseline in PANSS Negative Subscale Score for subjects continued from study D1050301 The Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; Negative subscale (range 7-49) is calculated as sum of Items N1 to N7 in the negative subscale Higher values of PANSS sub-scale scores represent greater severity of illness. |
| Secondary | Change From Baseline in PANSS General Psychopathology Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | Change from Baseline in PANSS General Psychopathology Subscale Score for subjects continued from study D1050301 The General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation; General psychopathology subscale (range 16-112) is calculated as sum of Items G1 to G16 in the general psychopathology subscale Higher values of PANSS sub-scale scores represent greater severity of illness. |
| Secondary | Change From Baseline in PANSS Excitability Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | Change from Baseline in PANSS Excitability Subscale Score for subjects continued from study D1050301 Subscale of Excitability consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control. The sum of the four items ranges from 4 to 28 Higher values of PANSS sub-scale scores represent greater severity of illness. |
| Secondary | Change From Baseline in the Clinical Global Impression -Severity Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | Change from Baseline in the Clinical Global Impression -Severity Score for subjects continued from study D1050301 The CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1='Normal, not at all ill' to 7='Among the most extremely ill patients'. A higher score is associated with greater illness severity |
| Secondary | Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | Change from Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score for subjects continued from study D1050301 The Children's Global Assessment Scale (CGAS) is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children under the age of 18, where 1 represents the most impaired functioning and 100, superior functioning. Each decile (e.g., 1-10, 11-20) has a descriptive header (e.g., "Moderate impairment in functioning in most domains") and examples of behaviors and types of environmental accommodations that might be seen at that level of functioning. Scores above 70 on the CGAS indicate functioning within the range of typically developing children of the same age as the child being rated while scores below 60 indicate a definite clinical case |
| Secondary | Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score for subjects continued from study D1050301 The Pediatric Q-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 Aberrant Behavior Checklist (ABC) Irritability Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | Change from Baseline in ABC Irritability Subscale Score for subjects continued from study D1050325 The Aberrant Behavior Checklist (ABC) contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). Irritability Subscale Score is calculated as summing of items 2, 4, 8, 10, 14, 19, 25, 29, 34, 36, 41, 47, 50, 52, and 57; as a result, ABC irritability subscale score ranges from 0 to 45. In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | During 104 Weeks (2-years) treatment period | The Safety population consists of all subjects who received at least one dose of study drug in this study. | Participants | NUMBER |
| SECONDARY | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in PANSS Positive Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in PANSS Negative Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in PANSS General Psychopathology Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | for subjects continued from study D1050301 | units on a scale | MEAN |
| SECONDARY | Change From Baseline in PANSS Excitability Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | for subjects continued from study D1050301 | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Clinical Global Impression -Severity Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | for subjects continued from study D1050301 | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | percent of score | MEAN | |
| SECONDARY | Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score | Open-Label Baseline, Week 28, Week 52, and Week 104 | units on a scale | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Rollover From D1050301 | Subjects with at least one treatment emergent AE | 214 | Participants | |
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Rollover From D1050325 | Subjects with at least one treatment emergent AE | 106 | Participants | |
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Rollover From D1050326 | Subjects with at least one treatment emergent AE | 252 | Participants | |
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Lurasidone (All Indications) | Subjects with at least one treatment emergent AE | 572 | Participants | |
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Rollover From D1050301 | Subjects with at least one treatment emergent SAE | 28 | Participants | |
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Rollover From D1050325 | Subjects with at least one treatment emergent SAE | 13 | Participants | |
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Rollover From D1050326 | Subjects with at least one treatment emergent SAE | 37 | Participants | |
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Lurasidone (All Indications) | Subjects with at least one treatment emergent SAE | 78 | Participants | |
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Rollover From D1050301 | Subjects with AE Leading to Discontinuation | 28 | Participants | |
| Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) | Rollover From D1050325 | Subjects with AE Leading to Discontinuation | 18 | Participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rollover From D1050301 | 271 | |
| Overall Study | STARTED | Rollover From D1050325 | 125 | |
| Overall Study | STARTED | Rollover From D1050326 | 306 | |
| Overall Study | COMPLETED | Rollover From D1050301 | 156 | |
| Overall Study | COMPLETED | Rollover From D1050325 | 54 | |
| Overall Study | COMPLETED | Rollover From D1050326 | 168 | |
| Overall Study | NOT COMPLETED | Rollover From D1050301 | 115 | |
| Overall Study | NOT COMPLETED | Rollover From D1050325 | 71 | |
| Overall Study | NOT COMPLETED | Rollover From D1050326 | 138 |
Source ClinicalTrials.gov
Adverse events272
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 | Rollover From D1050301 | 65 | 271 | 126 |
| other | Headache | Nervous system disorders | Rollover From D1050325 | 18 | 125 | 31 |
| other | Headache | Nervous system disorders | Rollover From D1050326 | 73 | 305 | 124 |
| other | Headache | Nervous system disorders | Total D1050302 | 156 | 701 | 281 |
| other | Somnolence | Nervous system disorders | Rollover From D1050301 | 24 | 271 | 26 |
| other | Somnolence | Nervous system disorders | Rollover From D1050325 | 14 | 125 | 17 |
| other | Somnolence | Nervous system disorders | Rollover From D1050326 | 30 | 305 | 30 |
| other | Somnolence | Nervous system disorders | Total D1050302 | 68 | 701 | 73 |
| other | Akathisia | Nervous system disorders | Rollover From D1050301 | 22 | 271 | 33 |
| other | Akathisia | Nervous system disorders | Rollover From D1050325 | 8 | 125 | 12 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rollover From D1050301 | 0 | 271 |
| Total, all-cause mortality | Rollover From D1050325 | 0 | 125 |
| Total, all-cause mortality | Rollover From D1050326 | 0 | 305 |
| Total, all-cause mortality | Total D1050302 | 0 | 701 |
| Total, other adverse events | Rollover From D1050301 | 184 | 271 |
| Total, other adverse events | Rollover From D1050325 | 94 | 125 |
| Total, other adverse events | Rollover From D1050326 | 198 | 305 |
| Total, other adverse events | Total D1050302 | 560 | 701 |
| Total, serious adverse events | Rollover From D1050301 | 28 | 271 |
| Total, serious adverse events | Rollover From D1050325 | 13 | 125 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34324397 | 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.
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/NCT01914393
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