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NCT01143077 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
A Phase 3 study of Schizophrenia and Schizoaffective Disorder, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 244
- Enrollment target
- 20
- Study locations
NCT01143077: Completed Phase 3 study of Schizophrenia and Schizoaffective Disorder, sponsored by Sumitomo Pharma America.
NCT01143077 is a Phase 3 study of Schizophrenia and Schizoaffective Disorder that has completed, run by Sumitomo Pharma America. The registered enrollment target is 244 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01143077, a Phase 3 study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 244 participants
- Enrollment target
- 20
- Study locations
Study Summary
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.
Primary Outcome
Relapse is defined as any occurrence of: * Insufficient clinical response * Exacerbation of underlying disease * Discontinuation due to an adverse event
Conditions Studied
Interventions
- DRUG Lurasidone HCl
Study Locations (20)
California
- Synergy Clinical Research of Escondido - Escondido
- Collaborative Neuroscience Network, Inc. - Garden Grove
- Pacific Research Partners, LLC - Oakland
- California Clinical Trials - Paramount
- Pasadena Research Institute - Pasadena
- California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC - Pico Rivera
- California Neuropsychopharmacology Clinical Research Institute (CNRI) - San Diego
- University of California San Diego Medical Center - San Diego
- Collaborative Neuroscience Network, South Bay - Torrance
Georgia
- Comprehensive NeuroScience, Inc. - Atlanta
- Medical College of Georgia - Augusta
New York
- Neurobehavioral Research, Inc. - Cedarhurst
- The Zucker Hillside Hospital - Glen Oaks
North Carolina
- Duke University Dept. of Psychiatry - Durham
- Wake Forest University Health Sciences - Winston-Salem
Arkansas
- K and S Professional Research Services - Little Rock
Colorado
- Western Affiliated Research Institute - Denver
Illinois
- University of Illinois at Chicago - Chicago
Louisiana
- Lake Charles Clinical Trials, LLC - Lake Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT01143077 record still lists
NCT01143077 is an interventional study that assigns participants to a tested intervention. The registered 244 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 (12% higher).
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Lurasidone HCl is the first listed.
NCT01143077 names 20 study sites across 9 states, led by California, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT01143077 about?
NCT01143077 is a clinical study titled "A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents". Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effecti...
What is the current status of trial NCT01143077?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 244 participants. The study started on 2010-06. Estimated completion is 2011-05.
What conditions does trial NCT01143077 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder.
What interventions are being tested in trial NCT01143077?
The interventions under investigation include: Lurasidone HCl (DRUG).
Who is sponsoring clinical trial NCT01143077?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01143077 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Georgia, Illinois. 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 NCT01143077's enrollment target sits among peer trials
244 78th of 315 higher than 237 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.
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