Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: Lurasidone HCl; Drug: Risperidone

• Study Type: Interventional
• Enrollment (Actual): 629
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5009BIN
    • Sanatorio 'Prof. Leon S. Morra' S.A.
  • BUE
    • Capital Federal, BUE, Argentina, C1425AHP
      • Fundación para el Estudio y Tratamiento de las Enf. Mentales
    • La Plata, BUE, Argentina, 1900
      • Clinica Privada Neuropsiquiatrica San Agustin
  • MEN
    • Mendoza, MEN, Argentina, M5502HLE
      • Resolution Psychopharmacology Research Institute
  • SFE
    • Rosario, SFE, Argentina, S2000QJI
      • CIAP
• Brazil
  • Aparecida de Goiania, Brazil, 74922-810
    • PAX Clinica Psiquiatrica Ltda
  • BA
    • Salvador, BA, Brazil, 40301-500
      • Sanatorio Sao Paulo
  • PR
    • Curitiba, PR, Brazil, 80520-000
      • Hospital Espirita de Psiquiatria Bom Retiro
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21020-130
      • Hospital Mario Kroeff
• Chile
  • Santiago, Chile
    • CIPAM - Clínica Pedro Montt
  • Valdivia, Chile
    • Hospital Base Valdivia
  • Santiago
    • Quinta Normal, Santiago, Chile
      • Hospital Clincio Felix Bulnes
    • Recoleta, Santiago, Chile
      • Instituto Psiquiátrico Dr. José Horwitz Barak
    • San Miguel, Santiago, Chile
      • Hospital Barros Luco Trudeau
• Croatia
  • Rijeka, Croatia, 51 000
    • Clinical Hospital Centre Rijeka
  • Zagreb, Croatia, 10 090
    • Psychiatric Hospital Vrapce
  • Zagreb, Croatia, 10000
    • Croatian institute for brain research Neuron
• Israel
  • Beer Yaakov, Israel, 70300
    • Beer Ya'acov Mental Health Center
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Hod Hasharon, Israel, 45100
    • Shalvata Mental Health Center
  • Hod Hasharon, Israel, 45100
    • Shalvata Mental Health Center, Ward B
  • Ramat Gan, Israel, 52621
    • Chaim Sheba Medical Center
• South Africa
  • Cape Town, South Africa, 7530
    • Cape Trial Centre
  • Natal, South Africa, 3600
    • Crompton Medical Centre East
  • Pretoria West, South Africa, 0001
    • Weskoppies Hospital
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Oranje Hospital
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2198
      • Rand Clinic
    • Pretoria, Gauteng, South Africa, 0181
      • Private Practice
  • W Cape
    • Cape Town, W Cape, South Africa, 7535
      • Flexivest Fourteen Research Centre
• Thailand
  • Bangkok
    • Chulalongkorn University, Bangkok, Thailand
      • King Chulalongkorn Memorial Hospital
    • Klongsan, Bangkok, Thailand
      • Somdet Chaopraya Institute of Psychiatry
  • Chiang Mai
    • Muang, Chiang Mai, Thailand
      • Suan Prung Psychiatric Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group, LLC
    • Little Rock, Arkansas, United States, 72201
      • K&S Professional Research Services LLC
  • California
    • Anaheim, California, United States, 92804
      • South Coast Clinical Trials, Inc.
    • Cerritos, California, United States, 90703
      • Comprehensive NeuroScience, Inc. - Cerritos
    • Costa Mesa, California, United States, 92626
      • Clinical Innovations Inc.
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network Inc
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Oceanside, California, United States, 92056
      • Excell Research
    • Orange, California, United States, 92868
      • University of California at Irvine Medical Center
    • Pasadena, California, United States, 91107
      • Pasadena Research Institute
    • Pico Rivera, California, United States, 90660
      • CNRI-Los Angeles, LLC
    • Riverside, California, United States, 92506
      • Clinical Innovations Inc.
    • San Diego, California, United States, 92102
      • CNRI-San Diego LLC
    • San Diego, California, United States, 92103
      • UCSD, Outpatient Psychiatric Services
    • Santa Ana, California, United States, 92705
      • Clinical Innovations Inc.
    • Torrance, California, United States, 90502
      • Collaborative Neuroscience Network Inc
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Comprehensive NeuroScience, Inc.
  • Florida
    • North Miami, Florida, United States, 33161
      • Fidelity Clinical Research Inc., c/o Segal Institute for Clinical Research
    • North Miami, Florida, United States, 33161
      • Fidelity Clinical Research Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
    • Tucker, Georgia, United States, 30084
      • Northlake Medical Research Center
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Alexian Brothers Medical Center
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Lake Charles Clinical Trials
  • Maryland
    • Baltimore, Maryland, United States, 21285
      • Sheppard Pratt Health System
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Center
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • St. Charles Psychiatric Associates - Midwest Research
    • St. Louis, Missouri, United States, 63118
      • St. Louis Clinical Trials
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University
  • New Jersey
    • Willingboro, New Jersey, United States, 08046
      • CRI Worldwide
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate University
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research Inc.
    • New York, New York, United States, 10035
      • Manhattan Psychiatric Center
    • New York, New York, United States, 10454
      • Social Psychiatry Research Institute
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • University of North Carolina at Chapel Hill
  • Pennsylvania
    • Norristown, Pennsylvania, United States, 19403
      • Keystone Clinical Studies, LLC
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Strategies of Memphis LLC
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • Dallas, Texas, United States, 75243
      • Pillar Clinical Research LLC
    • Houston, Texas, United States, 77008
      • Claghorn-Lesem Research Clinic, Inc.
  • Virginia
    • Richmond, Virginia, United States, 23230
      • Alliance Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

• Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
• Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
• Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
• Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
• Subject voluntarily agrees to participate in the study by giving written informed consent.

Main Exclusion Criteria:

To be excluded from entering this study if they fulfil any of the criteria below:

• Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
• Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
• In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
• Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2; Risperidone	Drug: Risperidone; Risperidone
Experimental: 1; Lurasidone	Drug: Lurasidone HCl; 40 - 120mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events.	12 months

Collaborators and Investigators

• Sponsor: Sunovion

Publications and helpful links

General Publications

• Keefe RS, Fox KH, Harvey PD, Cucchiaro J, Siu C, Loebel A. Characteristics of the MATRICS Consensus Cognitive Battery in a 29-site antipsychotic schizophrenia clinical trial. Schizophr Res. 2011 Feb;125(2-3):161-8. doi: 10.1016/j.schres.2010.09.015. Epub 2010 Dec 31.
• Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
• Citrome L, Cucchiaro J, Sarma K, Phillips D, Silva R, Tsuchiya S, Loebel A. Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. Int Clin Psychopharmacol. 2012 May;27(3):165-76. doi: 10.1097/YIC.0b013e32835281ef.
• Patel PJ, Weidenfeller C, Jones AP, Nilsson J, Hsu J. Long-Term Assessment of Lurasidone in Schizophrenia: Post Hoc Analysis of a 12-Month, Double Blind, Active-Controlled Trial and 6-Month Open-Label Extension Study. Neurol Ther. 2021 Jun;10(1):121-147. doi: 10.1007/s40120-020-00221-4. Epub 2020 Oct 24.
• Mattingly GW, Haddad PM, Tocco M, Xu J, Phillips D, Pikalov A, Loebel A. Switching to Lurasidone following 12 months of treatment with Risperidone: results of a 6-month, open-label study. BMC Psychiatry. 2020 May 5;20(1):199. doi: 10.1186/s12888-020-02523-1.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 18, 2008
• First Submitted That Met QC Criteria: March 21, 2008
• First Posted (Estimate): March 24, 2008

Study Record Updates

• Last Update Posted (Estimate): June 22, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Schizophrenia; Lurasidone; Latuda
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Risperidone; Lurasidone Hydrochloride
• Other Study ID Numbers: D1050237