A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder

NCT ID: NCT01143090

Last Updated: 2015-06-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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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 purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).

Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label

Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study.

Group Type EXPERIMENTAL

Lurasidone HCl

Intervention Type DRUG

40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months

Interventions

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Lurasidone HCl

40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).

Exclusion Criteria

* Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.
* Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director, MD

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

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K and S Professional Research Services

Little Rock, Arkansas, United States

Site Status

Synergy Clinical Research of Escondido

Escondido, California, United States

Site Status

Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

Site Status

Pacific Research Partners, LLC

Oakland, California, United States

Site Status

California Clinical Trials

Paramount, California, United States

Site Status

Pasadena Research Institute

Pasadena, California, United States

Site Status

California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC

Pico Rivera, California, United States

Site Status

California Neuropsychopharmacology Clinical Research Institute (CNRI)

San Diego, California, United States

Site Status

University of California San Diego Medical Center

San Diego, California, United States

Site Status

Collaborative Neuroscience Network, South Bay

Torrance, California, United States

Site Status

Western Affiliated Research Institute

Denver, Colorado, United States

Site Status

Comprehensive NeuroScience, Inc.

Atlanta, Georgia, United States

Site Status

Medical College of Georgia

Augusta, Georgia, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Site Status

St. Charles Psychiatric Associates - Midwest Research

Saint Charles, Missouri, United States

Site Status

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

Site Status

The Zucker Hillside Hospital

Glen Oaks, New York, United States

Site Status

Duke University Dept. of Psychiatry

Durham, North Carolina, United States

Site Status

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

CRI Worldwide - Kirkbride Center

Philadelphia, Pennsylvania, United States

Site Status

FutureSearch Clinical Trials, LP

Austin, Texas, United States

Site Status

FutureSearch Trials of Dallas

Dallas, Texas, United States

Site Status

Pillar Clinical Research, LLC

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Wharton Research Center

Wharton, Texas, United States

Site Status

University of Utah School of Medicine

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Citrome L, Weiden PJ, McEvoy JP, Correll CU, Cucchiaro J, Hsu J, Loebel A. Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study. CNS Spectr. 2014 Aug;19(4):330-9. doi: 10.1017/S109285291300093X. Epub 2013 Dec 16.

Reference Type RESULT
PMID: 24330868 (View on PubMed)

Awad G, Ng-Mak D, Rajagopalan K, Hsu J, Pikalov A, Loebel A. Long-term health-related quality of life improvements among patients treated with lurasidone: results from the open-label extension of a switch trial in schizophrenia. BMC Psychiatry. 2016 Jun 1;16:176. doi: 10.1186/s12888-016-0879-5.

Reference Type DERIVED
PMID: 27245981 (View on PubMed)

Other Identifiers

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D1050290

Identifier Type: -

Identifier Source: org_study_id

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