A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Lurasidone

Detailed Description

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Dole, France, 39100
    • Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)
  • Toulon, France, 83000
    • Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
• Italy
  • Massa, Italy, 54100
    • Dipartimento Salute Mentale ASL 1
  • Pisa, Italy, 56100
    • A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4
• Russian Federation
  • Lipetsk, Russian Federation, 398007
    • Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
  • Rostov-on-Don, Russian Federation, 344000
    • Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'
  • St. Peterburg, Russian Federation, 191167
    • St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
  • St. Petersburg, Russian Federation, 190005
    • St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7")
  • St. Petersburg, Russian Federation, 19005
    • St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1
  • St. Petersburg, Russian Federation, 191119
    • St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy, Clnic for Psychiatry
  • Dusica, Serbia, 11000
    • Institute of Mental Health
  • Kragujevac, Serbia, 34000
    • Clinical Centre Kragujevac, Clinic for psychiatry
  • Nis, Serbia, 18000
    • Clinical Centre Nis, Clinic for mental health protection
  • Novi Knezevac, Serbia, 23330
    • Specialized hospital for psychiatric diseases "Sveti Vracevi"
  • Novi Sad, Serbia, 21000
    • Clinical Centre Vojvodine, Clinic for Psychiatry
• Slovakia
  • Bojnice, Slovakia, 972 01
    • Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie
  • Bratislava, Slovakia, 82007
    • Psychiatricka Ambulancia Mentum S.R.O.
  • Michalovce, Slovakia, 071 01
    • Psychiatricka nemocnica Michalovce n.o.
  • Rimavska Sobota, Slovakia, 97901
    • PsychoLine s.r.o. Psychiatricka ambulancia
  • Roznava, Slovakia, 048 01
    • Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
  • Svidnik, Slovakia, 089 01
    • "Centrum zdravia R.B.K., spol. s.r.o.
• South Africa
  • Bloemfontein, South Africa, 9300
    • Research Unit, Department of Psychiatry Free State Psychiatric Complex
  • Pretoria, South Africa, 0081
    • Denmar Hospital Consulting Rooms
  • Western Cape
    • Tygervalley, Western Cape, South Africa, 7530
      • Cape Trial Centre
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Inc.
    • Little Rock, Arkansas, United States, 72201
      • K and S Professional Research Services
  • California
    • Cerritos, California, United States, 90703
      • Comprehensive Clinical Development Inc.
    • Downey, California, United States, 90241
      • Diligent Clinical Trials
    • Escondido, California, United States, 92025
      • Synergy Clinical Research Center
    • Garden Grove, California, United States, 92845
      • CNS Network
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • Oceanside, California, United States, 92056
      • Excell Research, Inc.
    • Pico Rivera, California, United States, 90660
      • CNRI-Los Angeles. LLC
    • San Diego, California, United States, 92126
      • California Neuropsychopharmacolgoy Clinical Research Insitute
    • Santa Ana, California, United States, 92701
      • Neuropsychiatric Research Center of Orange County
    • Torrance, California, United States, 90502
      • Collaborative Neuroscience Network
  • Florida
    • Bradenton, Florida, United States, 34208
      • Florida Clinical Research Center, LLC
    • Kissimmee, Florida, United States, 34742
      • Accurate Clinical Trials
    • Miami Springs, Florida, United States, 33166
      • Galiz Research
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
    • Atlanta, Georgia, United States, 30328
      • Comprehensive NeuroScience Inc.
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Lake Charles Clinical Trials, LLC
    • Shreveport, Louisiana, United States, 71104
      • Lousiana Clinical Research, LLC
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Center for Behavioral Health, LLC
  • Missouri
    • O'Fallon, Missouri, United States, 63368
      • Psychiatric Care and Research Center
    • Saint Louis, Missouri, United States, 63128
      • Psych Care Consultants Research
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Robert Lynn Horne, MD
  • New Jersey
    • Willingboro, New Jersey, United States, 08046
      • CRI Worldwide LLC
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center, Corp
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research Inc.
    • Fresh Meadows, New York, United States, 11366
      • Comprehensive Clinical Development, Inc
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Oklahoma Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide LLC at Kirkbride
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Lincoln Research
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • Austin, Texas, United States, 78756
      • FutureSearch Clinical Trials LP
    • Dallas, Texas, United States, 75243
      • Pillar Clinical Research, LLC
    • Dallas, Texas, United States, 75231
      • FutureSearch Clinical Trials, LP
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Department of Psychiatry, University of Utah Health Sciences Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subject has agreed to participate by providing written informed consent.
• Subject will be eligible to participate if one of the following criteria is met:
• Subject has completed the 28-week double-blind phase of study D1050238
• Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
• Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
• Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.
• Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

• Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
• Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
• Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lurasidone; Lurasidone 40 - 80mg flexible dose	Drug: Lurasidone; Lurasidone 40-80 mg taken orally taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)	Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)	12 weeks
Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score	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.	Baseline to week 12 LOCF endpoint
Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.	The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.	Baseline to week 12 LOCF endpoint

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score	The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.	Baseline to week 12 LOCF endpoint
Short Form-12 Health Survey (SF-12)	The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.	Baseline to week 12 LOCF endpoint
Modified Specific Levels of Functioning (SLOF) Total Score.	The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.	12 weeks
Brief Adherence Rating Scale (BARS)	The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.	12 weeks
Smoking Questionnaire	Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).	12 weeks
Intent to Attend Assessment	The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = "Not at all" and 9 = "Extremely". The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: "How likely is it that you will complete the study?"	12 weeks

Collaborators and Investigators

• Sponsor: Sunovion
• Investigators: Study Director: Lurasidone Medical Director, MD, Sunovion

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Schizophrenia; Lurasidone; Latuda
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; 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; Lurasidone Hydrochloride
• Other Study ID Numbers: D1050307; 2011-004790-90 (EudraCT Number)