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NCT01911429 · ClinicalTrials.gov registry record · Phase 3
Pediatric Schizophrenia Efficacy and Safety Study
A Phase 3 study of Schizophrenia, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 327
- Enrollment target
- 20
- Study locations
NCT01911429: Completed Phase 3 study of Schizophrenia, sponsored by Sumitomo Pharma America.
NCT01911429 is a Phase 3 study of Schizophrenia that has completed, run by Sumitomo Pharma America. The registered enrollment target is 327 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01911429, a Phase 3 study of Schizophrenia, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 327 participants
- Enrollment target
- 20
- Study locations
Study Summary
Efficacy and Safety study of Lurasidone in pediatric patients.
Primary Outcome
PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 -PANSS total score may range from 30 to 210- Higher values of PANSS total score represent greater severity of illness LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction.
Conditions Studied
Interventions
- DRUG Lurasidone 40 mg
- DRUG Lurasidone 80 mg
- DRUG Placebo 40 or 80 mg
Study Locations (20)
California
- California Pharmaceutical Research Institute, Inc - Anaheim
- Central Valley Medical Research - Bakersfield
- ProScience Research Group - Culver City
- Diligent Clinical Trials, Inc - Downey
- Collaborative Neuroscience Network, LLC - Garden Grove
- Global Clinical Trials, LLC - Irvine
- Neuropsychiatric Research Center of Orange County - Orange
- Asclepes Research - Panorama City
- CITrials, Inc. - Riverside & San Bernardino County - Riverside
Florida
- Florida Clinical Research Center, LLC - Bradenton
- Sarkis Clinical Trials - Parent - Gainesville
- APG Research, LLC - Orlando
- Medical Research Group of Central Florida - Sanford
Georgia
- Atlanta Center for Medical Research - Atlanta
- Institute for Behavioral Medicine, LLC - Smyrna
Alabama
- Harmonex Neuroscience Research - Dothan
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Baber Research Group - Naperville
Louisiana
- Lake Charles Clinical Trials, LLC - Lake Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT01911429 record still lists
NCT01911429 is an interventional study that assigns participants to a tested intervention. The registered 327 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Lurasidone 40 mg is the first listed.
NCT01911429 names 20 study sites across 8 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01911429 about?
NCT01911429 is a clinical study titled "Pediatric Schizophrenia Efficacy and Safety Study". Efficacy and Safety study of Lurasidone in pediatric patients.
What is the current status of trial NCT01911429?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 327 participants. The study started on 2013-08. Estimated completion is 2015-12.
What conditions does trial NCT01911429 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT01911429?
The interventions under investigation include: Lurasidone 40 mg (DRUG), Lurasidone 80 mg (DRUG), Placebo 40 or 80 mg (DRUG).
Who is sponsoring clinical trial NCT01911429?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01911429 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01911429's enrollment target sits among peer trials
327 52nd of 315 higher than 264 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
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