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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00790192
First received: November 10, 2008
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  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 short term among acutely psychotic patients with chronic schizophrenia.


Condition Intervention Phase
Schizophrenia
 Drug: Lurasidone
Drug: Quetiapine XR
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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:
  • Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment [ Time Frame: 6-Weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 488
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790192

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

Publications:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00790192     History of Changes
Other Study ID Numbers: D1050233
Study First Received: November 10, 2008
Results First Received: September 1, 2011
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Schizophrenia
SM-13496
Latuda
Lurasidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013