Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
- Registration Number
- NCT00789698
- 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 long term among schizophrenic outpatients with chronic schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- Completed all required assessments on the final study visit in Study D1050233.
- Suitable for treatment in an outpatient setting.
- Any chronic organic disease of the CNS (other than schizophrenia).
- Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quetiapine Quetiapine XR - Lurasidone HC1 Lurasidone HC1 -
- Primary Outcome Measures
Name Time Method Relapse of Psychotic Symptoms 12 Months Time to relapse will be defined as the earliest occurrence of any of the following:
* Worsening of \>= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale \>=3
* rehospitalization for worsening of psychosis
* emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.
- Secondary Outcome Measures
Name Time Method Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores. Baseline and 6 Months The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores Baseline and 12 months The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS) Baseline and 12 months The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).
Trial Locations
- Locations (62)
Florida Clinical Research Center LLC
🇺🇸Bradenton, Florida, United States
Pillar Clinical Research
🇺🇸Dallas, Texas, United States
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳Pune, Maharastra, India
Spitalul Judetean Arges
🇷🇴Pitesti, Romania
City Psychoneurological Dispensary #7 (with Hospital)
🇷🇺St-Petersburg, Russian Federation
Crimean republican Clinical Psychiatric Hospital
🇺🇦Simferopol, Ukraine
Kherson Regional Psychiatric Hospital
🇺🇦vil. Stepanovka, Kherson, Ukraine
Comprehensive Neuroscience, Inc.
🇺🇸Washington, District of Columbia, United States
Kyiv City Psychoneurological Hospital
🇺🇦Kyviv, Ukraine
Vijayawada Institute of Mental Health and Neurosciences
🇮🇳Vijayawada, Andhra Pradesh, India
Centro de Investigacion y Atencion para la Salud Mental
🇨🇴Calle 103A # 21-49, Bogota S/N, Colombia
Andreev, Boris
🇷🇺Gatchina, Russian Federation
CRI Worldwide
🇺🇸Willingboro, New Jersey, United States
Madras Medical College & Government General Hospital
🇮🇳Chennai, TamilNadu, India
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
🇺🇸Lake Charles, Louisiana, United States
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
🇨🇴Calle 80#47-43 Consultorio 5C, Barranquila S/N, Colombia
S.V. Medical College
🇮🇳Tirupati, Andra Pradesh, India
JSS Medical College and Hospital - Dept of Psychiatry
🇮🇳Mysore, Karna, India
Spitalul Clinic Judetean de Urgenta Arad
🇷🇴Str. Octavian Goga nr. 17, Arad, Romania
City Psychiatric Hospital #3 of Skvortsov-Stepanov
🇷🇺St. Petersburg, Russian Federation
Gurovich, Isaak
🇷🇺Moscow, Russian Federation
K&S Professional Research Services, LLC
🇺🇸Little Rock, Arkansas, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Comprehensive Neuroscience, Inc
🇺🇸Holliswood, New York, United States
Clinical Innovations, Inc.
🇺🇸Riverside, California, United States
Synergy Escondido,710 East Grand Ave.
🇺🇸Escondido, California, United States
Apostle Clinical Trials, Inc.
🇺🇸Long Beach, California, United States
Pasadena Research Institute
🇺🇸Pasadena, California, United States
California Clinical Trials
🇺🇸Paramount, California, United States
CNRI - Los Angeles LLC,8309 Telegraph Road
🇺🇸Pico Rivera, California, United States
CNRI- LOs Angeles, LLC
🇺🇸Pico Rivera, California, United States
UCSD Medical Drive
🇺🇸Sandeigo, California, United States
CNRI - San Diego
🇺🇸San Diego, California, United States
Booker, J. Gary, MD. APMC
🇺🇸Shreveport, Louisiana, United States
St. Charles Psychiatric Associates
🇺🇸St. Charles, Missouri, United States
St. Louis Research, Inc.
🇺🇸St. Louis, Missouri, United States
Community Clinical Research
🇺🇸Austin, Texas, United States
FutureSearch Clinical Trials, LLC.
🇺🇸Austin, Texas, United States
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
🇨🇴Barranquilla, Colombia
Centro de Investigación y Atención para la Salud Mental
🇨🇴Bogota, Colombia
CISNE - UIC Campo Abierto
🇨🇴Bogota, Colombia
Instituto Colombiano del Sistema Nervioso ClÃnica Montserrat
🇨🇴Bogota, Colombia
Shanti Nursing Home
🇮🇳Kanchanpalli, Aurangabad, Maharashtra, India
Seth K M School of P G Medicine & Research
🇮🇳Ahmedabad, Gujarat, India
SBKS Medical College and Hospital, Brij Psychiatry Hospital
🇮🇳Vadodara, Gujarat, India
Justice K.S. Hedge Charitable Hospital
🇮🇳Mangalore, Karna, India
Mahatma Gandhi Institute of Medical Sciences
🇮🇳Sewagram, Maharashtra, India
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
🇷🇴Bucuresti, Romania
Spitalul Clinic de Neurologie si Psihiatrie Oradea
🇷🇴Oradea, Romania
Morozova, Margarita
🇷🇺Moscow, Russian Federation
Sheifer, Mikhail
🇷🇺Samara, Russian Federation
City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
🇷🇺St. Petersburg, Russian Federation
City Psychiatric Hospital #4
🇷🇺St. Petersburg, Russian Federation
Neznanov, Nikolay
🇷🇺St. Petersburg, Russian Federation
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
🇺🇦Dnipropetrovsk, Ukraine
Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy
🇺🇦Donetsk, Ukraine
Kyiv City Clin. Psychoneurolog. Hosp.#1
🇺🇦Kyiv, Ukraine
Lviv Reg.St.Cl.Psych.Hosp
🇺🇦Lviv, Ukraine
Reg. Psychiatric Hospital
🇺🇦Odessa, Ukraine
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Segal Institute for Clinical Research
🇺🇸Highlands Ranch, Colorado, United States
Collaborative Neuroscience Network Inc
🇺🇸Garden Grove, California, United States