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COMPLETED Phase 3

A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

NCT01143077 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 244 participants
Start Date 2010-06
Est. Completion 2011-05
Phase Phase 3

Sponsor

Sumitomo Pharma America

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01143077

The ClinicalTrials.gov registry entry for NCT01143077 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01143077 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Georgia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01143077?

The interventions under investigation include: Lurasidone HCl (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01143077?

This trial is sponsored by Sumitomo Pharma America, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial