Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia. (PEARL 3)
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ClinicalTrials.gov Identifier: NCT00790192 |
Recruitment Status :
Completed
First Posted : November 13, 2008
Results First Posted : October 6, 2011
Last Update Posted : March 17, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Lurasidone Drug: Quetiapine XR Drug: Placebo | Phase 3 |
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 |

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 |
- 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: 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).

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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 |
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.

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

Study Director: | Medical Director, MD | Sunovion |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Schizophrenia SM-13496 Latuda Lurasidone |
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 |