Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia. (PEARL 3)

March 11, 2016 updated by: Sunovion

A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic 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.

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.
488

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

  • India
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • Vijayawada Institute of Mental Health and Neurosciences
    • Andra Pradesh
      • Tirupati, Andra Pradesh, India, 517507
        • S.V. Medical College
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Seth K M School of P G Medicine & Research
      • Vadodara, Gujarat, India, 391760
        • SBKS Medical Institute and Research Centre
    • Karnataka
      • Mangalore, Karnataka, India, 574160
        • Justice K.S. Hegde Charitable Hospital
      • Mysore, Karnataka, India, 570004
        • JSS Medical College and Hospital
    • Maharastra
      • Aurangabad, Maharastra, India, 431005
        • Shanti Nursing Home
      • Pune, Maharastra, India, 411004
        • Deenanath Mangeshkar Hospital and Research Centre
      • Sewagram, Maharastra, India, 442102
        • Mahatma Gandhi Institute of Medical Sciences
    • TamilNadu
      • Chennai, TamilNadu, India, 600003
        • Madras Medical College & Government General Hospital
  • Romania
      • Bucuresti, Romania
        • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
      • Oradea, Romania
        • Spitalul Clinic de Neurologie si Psihiatrie Oradea
    • Arad
      • Str. Octavian Goga nr. 17, Arad, Romania, 310022
        • Spitalul Clinic Județean De Urgența Arad
    • Bucuresti
      • Bdul Nicolae Grigorescu nr. 41, Bucuresti, Romania, 030440
        • Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
      • Sos. Berceni nr. 10-12, Bucuresti, Romania, 041914
        • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
    • Pitesti
      • Str. Negru Voda nr. 53, Pitesti, Romania, 110069
        • Spitalul Judetean Arges
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163060
        • SEI of H.P. Educat. Northern SMU
      • Gatchina, Russian Federation, 188357
        • St. Petersburg SHI Psychiatrical Hosptial #1 n.a. Kaschenko
      • Moscow, Russian Federation, 107076
        • Moscow Scientific Research Institute of Psychiatry
      • Moscow, Russian Federation, 115522
        • Institution of RAMS Mental Health Research Center of RAMS
      • Nizhniy Novgorod, Russian Federation, 603 155
        • City Clinical Psichiatric Hospital #1
      • Samara, Russian Federation, 443016
        • SHI Samara Psychiatric Hospital
      • St. Petersburg, Russian Federation
        • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
      • St. Petersburg, Russian Federation
        • City Psychiatric Hospital #3 of Skvortsov-Stepanov
      • St. Petersburg, Russian Federation
        • City Psychiatric Hospital #4
      • St. Petersburg, Russian Federation
        • SHI City Psychoneurological Dispensary #7
      • St. Petersburg, Russian Federation
        • St. Petersburg GUZ City Psychiatric Hospital #6
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • RCH n.a.I.I.Mechnikov, Reg.Cent. of Psychosom. Pathology
      • Donetsk, Ukraine, 83008
        • Chair of Psychiatry and Medical Psychology
      • Kyiv, Ukraine
        • Centre of Novel Treatment and Rehabilitation of Psychotic disorders
      • Kyviv, Ukraine
        • Kyiv City Psychoneurological Hospital
      • Lviv, Ukraine
        • Lviv Reg.St.Cl.Psych.Hosp
      • Odessa, Ukraine
        • Reg. Psychiatric Hospital
      • Poltava, Ukraine
        • Poltava Regional Clinical Psychiatric Hospital,
      • Simferopol, Ukraine
        • Crimean republican Clinical Psychiatric Hospital
    • Stepanovka
      • Kherson,vil., Stepanovka, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group
      • Little Rock, Arkansas, United States, 72201
        • K&S Professional Research Services, LLC
    • California
      • Cerritos, California, United States, 90703
        • Clinical Pharmacological Studies, Inc.
      • Cerritos, California, United States, 90703
        • Comprehensive Neuroscience, Inc
      • Costa Mesa, California, United States, 92647
        • Clinical Innovations, Inc.
      • Escondido, California, United States, 92025
        • Synergy Escondido
      • Garden Grove, California, United States, 92645
        • Collaborative Neuroscience Network
      • Long Beach, California, United States, 90813
        • Apostle Clinical Trials, Inc.
      • Paramount, California, United States, 90723
        • California Clinical Trials
      • Pasadena, California, United States, 91107
        • Pasadena Research Institute
      • Pico Rivera, California, United States, 90660
        • CNRI-Los Angeles. LLC
      • Riverside, California, United States, 92647
        • Clinical Innovations, Inc.
      • San Diego, California, United States, 92126
        • Cnri-San Diego
      • Sandeigo, California, United States, 92103
        • UCSD Medical Center
    • Colorado
      • Highlands Ranch, Colorado, United States, 80103
        • Segal Institute for Clinical Research
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Comprehensive NeuroScience, Inc.
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center
      • Fruitland Park, Florida, United States, 34731
        • Florida Clinical Research Center, LLC
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Lake Charles Clinical Trials
      • Shreveport, Louisiana, United States, 71104
        • Booker, J. Gary, MD. APMC
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Clinical Research
    • Missouri
      • St Charles, Missouri, United States, 63301
        • St. Charles Psychiatric Associates
      • St. Louis, Missouri, United States, 63118
        • St. Louis Research, Inc.
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide
    • New York
      • Holliswood, New York, United States, 11423
        • Comprehensive Neuroscience, Inc
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Segal Institute for Clinical Research
    • Texas
      • Austin, Texas, United States, 78756
        • Future Search Trials of Neurology
      • Austin, Texas, United States, 78729
        • Community Clinical Research
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provide written informed consent and aged between 18 and 75 years of age.
  • Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
  • Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
  • Able and agrees to remain off prior antipsychotic medication for the duration of study.
  • Good physical health on the basis of medical history, physical examination, and laboratory screening.
  • Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

  • Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
  • Any chronic organic disease of the CNS (other than schizophrenia).
  • Used investigational compound within 30 days.
  • Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Placebo Comparator: Placebo
Drug: Placebo
Matching Placebo to Lurasidone or Quetiapine
Active Comparator: Quetiapine XR
Drug: Quetiapine XR
Quetiapine XR 600mg
Experimental: Lurasidone 80mg
Drug: Lurasidone
Lurasidone 80 mg tablets
Drug: Lurasidone
Lurasidone 4 40 mg tablets
Experimental: Lurasidone 160mg
Drug: Lurasidone
Lurasidone 80 mg tablets
Drug: Lurasidone
Lurasidone 4 40 mg tablets

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
Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
Time Frame: Week 6
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Week 6

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
Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
Time Frame: 6-Weeks
Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
6-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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 1, 2008

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.
July 1, 2010

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.
July 1, 2010

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).
November 10, 2008

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.
November 12, 2008

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.
November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

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.
March 17, 2016

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.
March 11, 2016

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.
March 1, 2016

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.
  • D1050233

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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