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

April 2, 2019 updated by: Sunovion

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
191

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)
Time Frame: 12 weeks
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
Time Frame: Baseline to week 12 LOCF endpoint
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.
Time Frame: Baseline to week 12 LOCF endpoint
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score
Time Frame: Baseline to week 12 LOCF endpoint
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)
Time Frame: Baseline to week 12 LOCF endpoint
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.
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).
12 weeks
Intent to Attend Assessment
Time Frame: 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunovion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lurasidone Medical Director, MD, Sunovion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1050307
  • 2011-004790-90 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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