Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia. - Full Text View

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 (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)

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Lurasidone

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 ]
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 ]
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)
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

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

Sponsors and Collaborators

Sunovion

Investigators


Study Director:	Medical Director, MD	Sunovion

More Information

Publications:

Loebel A, Cucchiaro J, Sarma K, Xu L, Hsu C, Kalali AH, Pikalov A, Potkin SG. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophr Res. 2013 Apr;145(1-3):101-9. doi: 10.1016/j.schres.2013.01.009. Epub 2013 Feb 13.

Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.

Loebel AD, Siu CO, Cucchiaro JB, Pikalov AA, Harvey PD. Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia. CNS Spectr. 2014 Apr;19(2):197-205. doi: 10.1017/S1092852913000904. Epub 2013 Dec 13.

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

Harvey PD, Siu CO, Ogasa M, Loebel A. Effect of lurasidone dose on cognition in patients with schizophrenia: post-hoc analysis of a long-term, double-blind continuation study. Schizophr Res. 2015 Aug;166(1-3):334-8. doi: 10.1016/j.schres.2015.06.008. Epub 2015 Jun 24.

Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.


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

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 June 23, 2017

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