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Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia (PEARL 3 Ext)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789698
First Posted: November 13, 2008
Last Update Posted: June 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunovion
  Purpose
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 long term among schizophrenic outpatients with chronic schizophrenia.

Condition Intervention Phase
Chronic Schizophrenia Drug: Lurasidone HC1 Drug: Quetiapine XR Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study)

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Relapse of Psychotic Symptoms [ Time Frame: 12 Months ]

    Time to relapse will be defined as the earliest occurrence of any of the following:

    • Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3
    • rehospitalization for worsening of psychosis
    • emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.


Secondary Outcome Measures:
  • Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores. [ Time Frame: Baseline and 6 Months ]
    The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.

  • Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline and 12 months ]
    The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).

  • Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores [ Time Frame: Baseline and 12 months ]
    The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.


Enrollment: 240
Study Start Date: December 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone HC1 Drug: Lurasidone HC1
Lurasidone 40-160 mg/day flexibly dosed.
Active Comparator: Quetiapine Drug: Quetiapine XR
Quetiapine XR 200-800 mg/day flexibly dosed.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Entry Criteria:

  • Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent.

Inclusion Criteria:

  • Completed all required assessments on the final study visit in Study D1050233.
  • Suitable for treatment in an outpatient setting.

Exclusion Criteria:

  • Any chronic organic disease of the CNS (other than schizophrenia).
  • Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789698


  Show 65 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00789698     History of Changes
Other Study ID Numbers: D1050234
First Submitted: November 10, 2008
First Posted: November 13, 2008
Results First Submitted: March 27, 2012
Results First Posted: August 21, 2012
Last Update Posted: June 12, 2015
Last Verified: May 2015

Keywords provided by Sunovion:
Schizophrenia
SM-13496
Latuda
Lurasidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents