Trials / Completed
CompletedNCT01911429
Pediatric Schizophrenia Efficacy and Safety Study
A 6-Week Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study To Evaluate The Efficacy and Safety of Lurasidone in Adolescent Subjects With Schizophrenia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 327 (actual)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Efficacy and Safety study of Lurasidone in pediatric patients.
Detailed description
To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision \[DSM-IV-TR\] criteria) as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lurasidone 40 mg | Lurasidone 40 mg once daily |
| DRUG | Lurasidone 80 mg | Lurasidone 80 mg once daily |
| DRUG | Placebo 40 or 80 mg | Placebo 40 or 80 mg once daily |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2013-07-30
- Last updated
- 2017-04-18
- Results posted
- 2017-03-22
Locations
90 sites across 17 countries: United States, Belgium, Bulgaria, Colombia, France, Hungary, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01911429. Inclusion in this directory is not an endorsement.