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

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.
 
ClinicalTrials.gov Identifier: NCT00790192
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : October 6, 2011
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone Drug: Quetiapine XR Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Lurasidone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lurasidone 80mg Drug: Lurasidone
Lurasidone 80 mg tablets
Experimental: Lurasidone 160mg Drug: Lurasidone
Lurasidone 4 40 mg tablets
Active Comparator: Quetiapine XR Drug: Quetiapine XR
Quetiapine XR 600mg
Placebo Comparator: Placebo Drug: Placebo
Matching Placebo to Lurasidone or Quetiapine


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


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

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.
Contacts and Locations
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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): NCT00790192


Locations
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Sponsors and Collaborators
Sunovion
Investigators
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Study Director: Medical Director, MD Sunovion
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00790192    
Other Study ID Numbers: D1050233
First Posted: November 13, 2008    Key Record Dates
Results First Posted: October 6, 2011
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by Sunovion:
Schizophrenia
SM-13496
Latuda
Lurasidone
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Lurasidone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of 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