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NCT01821378 · ClinicalTrials.gov registry record · Phase 3
Lurasidone Low-Dose - High-Dose Study Study
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 412
- Enrollment target
NCT01821378: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT01821378 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 412 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01821378, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 412 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.
Primary Outcome
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. 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. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
Interventions
- DRUG Placebo
- DRUG Lurasidone
- DRUG Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01821378 record still lists
NCT01821378 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01821378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01821378 about?
NCT01821378 is a clinical study titled "Lurasidone Low-Dose - High-Dose Study Study". The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.
What is the current status of trial NCT01821378?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2013-05. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01821378?
The interventions under investigation include: Placebo (DRUG), Lurasidone (DRUG), Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 (DRUG).
Who is sponsoring clinical trial NCT01821378?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01821378's enrollment target sits among peer trials
412 906th of 2000 higher than 1,092 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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