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Safety and Tolerability Study of Drug to Treat Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lurasidone 20 mg
Lurasidone 40 mg
Lurasidone 80mg
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, Latuda, Lurasidone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Successful completion of participation in protocol #D1050049 Exclusion criteria: Substance abuse Prolactin level of ≥200ng/mL at baseline Pregnancy

Sites / Locations

  • Birmingham Psychiatry Pharmaceutical
  • Institute for Psychopharmacology Research
  • CNS Network
  • California Clinical Trials Medical Group
  • Optimum Health Services
  • University of California, Irvine
  • California Neuropsychopharmacology Clinical Research Institute
  • Psychiatric Institute of Washington
  • Comprehensive Neuroscience. Inc.
  • Segal Institute for Clinical Research
  • University of South Florida
  • Coordinated Research of Florida, Inc
  • Hawaii Research Center
  • Alexian Brothers Behavioral Health Hospital
  • American Medical Research
  • Lake Mead Hospital
  • Comprehensive Clinical Research, CNS
  • ClinSearch, Inc.
  • Quantum Clinical Services Group
  • Albert Einstein Medical Center
  • Community Clinical Research
  • FutureSearch Trials
  • Claghorn Lesem Research Clinic, Inc.
  • St. Paul Medical Center
  • CNS, Inc.
  • Medstream, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lurasidone 20 mg

Lurasidione 40 mg

Lurasidone 80mg

Arm Description

Lurasidone 20 mg oral tablet

Lurasidone 40 mg oral tablet

Lurasidone 80mg oral tablet

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2002
Last Updated
March 31, 2014
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00044005
Brief Title
Safety and Tolerability Study of Drug to Treat Schizophrenia
Official Title
A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone 20 mg
Arm Type
Experimental
Arm Description
Lurasidone 20 mg oral tablet
Arm Title
Lurasidione 40 mg
Arm Type
Experimental
Arm Description
Lurasidone 40 mg oral tablet
Arm Title
Lurasidone 80mg
Arm Type
Experimental
Arm Description
Lurasidone 80mg oral tablet
Intervention Type
Drug
Intervention Name(s)
Lurasidone 20 mg
Intervention Description
Lurasidone 20mg oral tablet taken once daily for 6-months
Intervention Type
Drug
Intervention Name(s)
Lurasidone 40 mg
Intervention Description
Lurasidone 40mg oral tablets taken once daily
Intervention Type
Drug
Intervention Name(s)
Lurasidone 80mg
Intervention Description
Lurasidone 80mg oral tablet taken once daily
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Successful completion of participation in protocol #D1050049 Exclusion criteria: Substance abuse Prolactin level of ≥200ng/mL at baseline Pregnancy
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
Birmingham Psychiatry Pharmaceutical
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Institute for Psychopharmacology Research
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
CNS Network
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
California Clinical Trials Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Optimum Health Services
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Neuropsychopharmacology Clinical Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
Psychiatric Institute of Washington
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Comprehensive Neuroscience. Inc.
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Coordinated Research of Florida, Inc
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Hawaii Research Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Alexian Brothers Behavioral Health Hospital
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
American Medical Research
City
Oakbrook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Lake Mead Hospital
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Comprehensive Clinical Research, CNS
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
ClinSearch, Inc.
City
Kenilworth
State/Province
New Jersey
ZIP/Postal Code
07033
Country
United States
Facility Name
Quantum Clinical Services Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Claghorn Lesem Research Clinic, Inc.
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
St. Paul Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
CNS, Inc.
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22041
Country
United States
Facility Name
Medstream, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53210
Country
United States

12. IPD Sharing Statement

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Safety and Tolerability Study of Drug to Treat Schizophrenia

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