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A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lurasidone 20 mg
Lurasidone 40mg
Lurasidone 80 mg
Haloperidol 10mg
Placebo
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 - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: The patient has a primary diagnosis of schizophrenia The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening The patient has had a duration of illness of at least one year. The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS The patient is able to remain off antipsychotic medication for a 4 day washout period Exclusion criteria: The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening. The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/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
  • Affiliated Research Institute
  • Sharp Mesa Vista Hospital
  • California Neuropsychopharmacolgoy Clinical Research Insitute
  • Comprehensive Neuroscience. Inc.
  • Comprehensive Neuroscience. Inc.
  • Segal Institute for Clinical Research
  • University of South Florida
  • Coordinated Research of Florida, Inc.
  • Atlanta Center for Medical Research
  • Carman Research
  • Hawaii Research Center
  • Alexian Brothers Behavioral Health Hospital
  • American Medical Research
  • Centers for Behavioral Health, LLC
  • Lake Mead Hospital
  • Comprehensive Clinical Research CNS, PC
  • ClinSearch, Inc.
  • Psychiatric Professional Services Inc
  • Quantum Clinical Services Group
  • Albert Einstein Medical Center - Dept. of Psychiatry
  • Community Clinical Research
  • FutureSearch Trials
  • Claghorn Lesem Research Clinic, Inc.
  • St. Paul Medical Center
  • University Hills Clinical Research
  • CNS, Inc.
  • Northwest Clinical Research Center
  • Medstream, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Lurasidone 20 mg

Lurasidone 40 mg

Lurasidone 80 mg

Haloperidol 10mg

Placebo

Arm Description

Lurasidone 20 mg tablets

Lurasidone 40 mg tablets

Lurasidone 2 40 mg tablets

Haloperidol 10mg tablets

Matching Placebo to Lurasidone and Haloperidol

Outcomes

Primary Outcome Measures

Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.

Secondary Outcome Measures

Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.

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
NCT00044044
Brief Title
A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
Official Title
A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 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 efficacy of the drug SM-13496 compared to a placebo and to haloperidol 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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone 20 mg
Arm Type
Experimental
Arm Description
Lurasidone 20 mg tablets
Arm Title
Lurasidone 40 mg
Arm Type
Experimental
Arm Description
Lurasidone 40 mg tablets
Arm Title
Lurasidone 80 mg
Arm Type
Experimental
Arm Description
Lurasidone 2 40 mg tablets
Arm Title
Haloperidol 10mg
Arm Type
Active Comparator
Arm Description
Haloperidol 10mg tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo to Lurasidone and Haloperidol
Intervention Type
Drug
Intervention Name(s)
Lurasidone 20 mg
Intervention Description
Lurasidone 20mg/day tablets
Intervention Type
Drug
Intervention Name(s)
Lurasidone 40mg
Intervention Description
Lurasidone 40mg/day tablets
Intervention Type
Drug
Intervention Name(s)
Lurasidone 80 mg
Intervention Description
Lurasidone 80mg/day - 2 40mg tablets
Intervention Type
Drug
Intervention Name(s)
Haloperidol 10mg
Intervention Description
Haloperidol 10mg/day tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo to Lurasdione and Haloperidol
Primary Outcome Measure Information:
Title
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
Description
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
Description
The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
Description
The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time Frame
Baseline and 6 weeks
Title
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
Description
The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: The patient has a primary diagnosis of schizophrenia The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening The patient has had a duration of illness of at least one year. The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS The patient is able to remain off antipsychotic medication for a 4 day washout period Exclusion criteria: The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening. The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/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
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
California Neuropsychopharmacolgoy Clinical Research Insitute
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
Comprehensive Neuroscience. Inc.
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
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
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
Centers for Behavioral Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
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, PC
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
Psychiatric Professional Services Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
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 - Dept. of Psychiatry
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
University Hills Clinical Research
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
Northwest Clinical Research Center
City
Belleview
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Medstream, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

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