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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Quetiapine XR; Drug: Placebo; Drug: Lurasidone

• Registration Number: NCT00790192
• Lead Sponsor: Sumitomo Pharma America, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-12
• Study First Posted: 2008-11-13
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-09-01
• Results First Submitted QC: 2011-09-01
• Results First Posted: 2011-10-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quetiapine XR	Quetiapine XR	-
Placebo	Placebo	-
Lurasidone 80mg	Lurasidone	-
Lurasidone 160mg	Lurasidone	-

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase	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

Name	Time	Method
Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment	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).

Trial Locations

Locations (61)

CNRI-Los Angeles. LLC; 🇺🇸 Pico Rivera, California, United States

Florida Clinical Research Center; 🇺🇸 Bradenton, Florida, United States

Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"; 🇷🇴 Bdul Nicolae Grigorescu nr. 41, Bucuresti, Romania

JSS Medical College and Hospital; 🇮🇳 Mysore, Karnataka, India

Vijayawada Institute of Mental Health and Neurosciences; 🇮🇳 Vijayawada, Andhra Pradesh, India

Spitalul Clinic Judetean de Urgenta Arad; 🇷🇴 Str. Octavian Goga nr. 17, Arad, Romania

Madras Medical College & Government General Hospital; 🇮🇳 Chennai, TamilNadu, India

CNRI-San Diego; 🇺🇸 San Diego, California, United States

Comprehensive Neuroscience, Inc.; 🇺🇸 Washington, District of Columbia, United States

Lake Charles Clinical Trials; 🇺🇸 Lake Charles, Louisiana, United States

Community Clinical Research; 🇺🇸 Austin, Texas, United States

S.V. Medical College; 🇮🇳 Tirupati, Andra Pradesh, India

Shanti Nursing Home; 🇮🇳 Aurangabad, Maharastra, India

Mahatma Gandhi Institute of Medical Sciences; 🇮🇳 Sewagram, Maharastra, India

Centre of Novel Treatment and Rehabilitation of Psychotic disorders; 🇺🇦 Kyiv, Ukraine

Booker, J. Gary, MD. APMC; 🇺🇸 Shreveport, Louisiana, United States

St. Petersburg SHI Psychiatrical Hosptial #1 n.a. Kaschenko; 🇷🇺 Gatchina, Russian Federation

Spitalul Clinic de Neurologie si Psihiatrie Oradea; 🇷🇴 Oradea, Romania

Pillar Clinical Research; 🇺🇸 Dallas, Texas, United States

RCH n.a.I.I.Mechnikov, Reg.Cent. of Psychosom. Pathology; 🇺🇦 Dnipropetrovsk, Ukraine

Kyiv City Psychoneurological Hospital; 🇺🇦 Kyviv, Ukraine

City Psychiatric Hospital #4; 🇷🇺 St. Petersburg, Russian Federation

CRI Worldwide; 🇺🇸 Willingboro, New Jersey, United States

K&S Professional Research Services, LLC; 🇺🇸 Little Rock, Arkansas, United States

SHI City Psychoneurological Dispensary #7; 🇷🇺 St. Petersburg, Russian Federation

Justice K.S. Hegde Charitable Hospital; 🇮🇳 Mangalore, Karnataka, India

Chair of Psychiatry and Medical Psychology; 🇺🇦 Donetsk, Ukraine

Crimean republican Clinical Psychiatric Hospital; 🇺🇦 Simferopol, Ukraine

St. Petersburg GUZ City Psychiatric Hospital #6; 🇷🇺 St. Petersburg, Russian Federation

Institution of RAMS Mental Health Research Center of RAMS; 🇷🇺 Moscow, Russian Federation

Spitalul Judetean Arges; 🇷🇴 Str. Negru Voda nr. 53, Pitesti, Romania

SEI of H.P. Educat. Northern SMU; 🇷🇺 Arkhangelsk, Russian Federation

SBKS Medical Institute and Research Centre; 🇮🇳 Vadodara, Gujarat, India

St. Louis Research, Inc.; 🇺🇸 St. Louis, Missouri, United States

St. Charles Psychiatric Associates; 🇺🇸 St Charles, Missouri, United States

Clinical Innovations, Inc.; 🇺🇸 Riverside, California, United States

Collaborative Neuroscience Network; 🇺🇸 Garden Grove, California, United States

UCSD Medical Center; 🇺🇸 Sandeigo, California, United States

Synergy Escondido; 🇺🇸 Escondido, California, United States

Pasadena Research Institute; 🇺🇸 Pasadena, California, United States

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; 🇷🇴 Bucuresti, Romania

City Clinical Psichiatric Hospital #1; 🇷🇺 Nizhniy Novgorod, Russian Federation

City Psychiatric Hospital #3 of Skvortsov-Stepanov; 🇷🇺 St. Petersburg, Russian Federation

SHI Samara Psychiatric Hospital; 🇷🇺 Samara, Russian Federation

Precise Clinical Research; 🇺🇸 Flowood, Mississippi, United States

Woodland International Research Group; 🇺🇸 Little Rock, Arkansas, United States

Clinical Pharmacological Studies, Inc.; 🇺🇸 Cerritos, California, United States

Apostle Clinical Trials, Inc.; 🇺🇸 Long Beach, California, United States

Comprehensive Neuroscience, Inc; 🇺🇸 Holliswood, New York, United States

California Clinical Trials; 🇺🇸 Paramount, California, United States

Segal Institute for Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Florida Clinical Research Center, LLC; 🇺🇸 Fruitland Park, Florida, United States

Future Search Trials of Neurology; 🇺🇸 Austin, Texas, United States

Seth K M School of P G Medicine & Research; 🇮🇳 Ahmedabad, Gujarat, India

Deenanath Mangeshkar Hospital and Research Centre; 🇮🇳 Pune, Maharastra, India

Moscow Scientific Research Institute of Psychiatry; 🇷🇺 Moscow, Russian Federation

City Psychiatric Hospital #2 of St. Nikolay Chudotvorets; 🇷🇺 St. Petersburg, Russian Federation

Kherson Regional Psychiatric Hospital; 🇺🇦 Kherson,vil., Stepanovka, Ukraine

Lviv Reg.St.Cl.Psych.Hosp; 🇺🇦 Lviv, Ukraine

Reg. Psychiatric Hospital; 🇺🇦 Odessa, Ukraine

Poltava Regional Clinical Psychiatric Hospital,; 🇺🇦 Poltava, Ukraine