Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia. (PEARL 3)
This study has been completed.
Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00790192
First received: November 10, 2008
Last updated: March 11, 2016
Last verified: March 2016
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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:
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 (Adult, Senior) |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790192
Show 65 Study 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | March 11, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 29, 2016