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Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lurasidone HCl
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, SM-13496, Latuda, Lurasidone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following 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.

Sites / Locations

  • K&S Professional Research Services, LLC.
  • Comprehensive Neuroscience, Inc
  • Clinical Innovations, Inc.
  • Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
  • California Clinical Trials
  • Pasadena Research Institute
  • California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
  • Sharp Mesa Vista Hospital
  • Comprehensive Neuroscience, Inc.
  • Florida Clinical Research Center, LLC
  • Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.
  • Atlanta Center for Medical Research
  • Alexian Brothers Health System
  • Lake Charles Clinical Trials LLC
  • Booker, J. Gary, MD. APMC
  • Center for Behavioral Health, LLC
  • SUNY Downstate Medical Center
  • Erie County Medical Center, Corp
  • CRI Worldwide LLC at Kirkbride
  • Research Strategies of Memphis, LLC.
  • Future Search Trials of Neurology
  • Hospital Caremeau
  • S V Medical College
  • Government Hospital for Mental Care
  • Sheth Vadilal Sarabhai General Hospital
  • Shanti Nursing Home
  • Madras Medical College & Government General Hospital
  • Deva Mental Health Care
  • Hospital Permai
  • University Malaya Medical Centre
  • Spitalul Clinic Judetean de Urgenta Arad
  • Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
  • Centrul de Recuperare si Reabilitare Gura Ocnitei
  • Spitalul Judetean Arges
  • North State Medical University
  • Republic Psychiatric Hospital
  • City Psychoneurological Dispensary #7 (with Hospital)
  • City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
  • City Psychiatric Hospital #4
  • Bekhterev Psychoneurological Research Institute
  • City Psychiatric Hospital #3 of Skvortsov-Stepanov
  • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
  • Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
  • Kyiv City Clin. Psychoneurolog. Hosp.#1
  • Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp
  • Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
  • Kherson Regional Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lurasidone 40mg

Lurasidone 80mg

Lurasidone 120mg

Sugar Pill

Arm Description

Outcomes

Primary Outcome Measures

Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
The PANSS 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

CGI-S From Baseline to the End of the Double-blind Treatment
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).

Full Information

First Posted
October 24, 2007
Last Updated
June 5, 2014
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00549718
Brief Title
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Official Title
A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, SM-13496, Latuda, Lurasidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
489 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone 40mg
Arm Type
Experimental
Arm Title
Lurasidone 80mg
Arm Type
Experimental
Arm Title
Lurasidone 120mg
Arm Type
Experimental
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lurasidone HCl
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
Description
The PANSS 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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
CGI-S From Baseline to the End of the Double-blind Treatment
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be eligible to enter the study, each patient must comply with the following 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
K&S Professional Research Services, LLC.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Comprehensive Neuroscience, Inc
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
City
Garden Grove
State/Province
California
ZIP/Postal Code
92645
Country
United States
Facility Name
California Clinical Trials
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Pasadena Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Comprehensive Neuroscience, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Alexian Brothers Health System
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Lake Charles Clinical Trials LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Booker, J. Gary, MD. APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Center for Behavioral Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Erie County Medical Center, Corp
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
CRI Worldwide LLC at Kirkbride
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Research Strategies of Memphis, LLC.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Future Search Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Hospital Caremeau
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
S V Medical College
City
Tirupati
State/Province
Andh Prad
ZIP/Postal Code
517507
Country
India
Facility Name
Government Hospital for Mental Care
City
Visakhapatnam
State/Province
Andh Prad
ZIP/Postal Code
530017
Country
India
Facility Name
Sheth Vadilal Sarabhai General Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Shanti Nursing Home
City
Aurangabad
State/Province
Mahara
ZIP/Postal Code
431005
Country
India
Facility Name
Madras Medical College & Government General Hospital
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600003
Country
India
Facility Name
Deva Mental Health Care
City
Varanasi
State/Province
Uttar Prad
ZIP/Postal Code
221005
Country
India
Facility Name
Hospital Permai
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
81200
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Spitalul Clinic Judetean de Urgenta Arad
City
Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
City
Bucuresti
ZIP/Postal Code
030442
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Centrul de Recuperare si Reabilitare Gura Ocnitei
City
Gura Ocnitei
ZIP/Postal Code
130083
Country
Romania
Facility Name
Spitalul Judetean Arges
City
Pitesti
ZIP/Postal Code
110069
Country
Romania
Facility Name
North State Medical University
City
Arkhangelsk
ZIP/Postal Code
163060
Country
Russian Federation
Facility Name
Republic Psychiatric Hospital
City
Karelia
ZIP/Postal Code
111111
Country
Russian Federation
Facility Name
City Psychoneurological Dispensary #7 (with Hospital)
City
St. Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
City Psychiatric Hospital #4
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Bekhterev Psychoneurological Research Institute
City
St. Petersburg
ZIP/Postal Code
193019
Country
Russian Federation
Facility Name
City Psychiatric Hospital #3 of Skvortsov-Stepanov
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
City
Donetsk
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
Kyiv City Clin. Psychoneurolog. Hosp.#1
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Hospital
City
vil. Stepanovka, Kherson
ZIP/Postal Code
73488
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
23421963
Citation
Nasrallah HA, Silva R, Phillips D, Cucchiaro J, Hsu J, Xu J, Loebel A. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: a 6-week, randomized, placebo-controlled study. J Psychiatr Res. 2013 May;47(5):670-7. doi: 10.1016/j.jpsychires.2013.01.020. Epub 2013 Feb 17.
Results Reference
result
PubMed Identifier
34751928
Citation
Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
Results Reference
derived
PubMed Identifier
27048911
Citation
Correll CU, Cucchiaro J, Silva R, Hsu J, Pikalov A, Loebel A. Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study. CNS Spectr. 2016 Oct;21(5):393-402. doi: 10.1017/S1092852915000917. Epub 2016 Apr 6.
Results Reference
derived
PubMed Identifier
24955752
Citation
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.
Results Reference
derived

Learn more about this trial

Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

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