Back to resultsStudy Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
bifeprunox
risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion criteria: Current treatment of at least 3 months with risperidone. Primary diagnosis of schizophrenia. Total Positive and Negative Symptoms Scale (PANSS) score < or = 70 at screening and baseline. Exclusion criteria: Psychiatric diagnosis other than schizophrenia as assessed by the modified Mini International Neuropsychiatric Interview (MINI) and considered by the investigator to be the primary psychiatric diagnosis. History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study. History of any suicide attempt within 3 years of day 1 or significant immediate risk of violence or suicidality.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
The primary analysis will be the change from baseline on body weight at the final evaluation.
Secondary Outcome Measures
Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.
Full Information
NCT ID
NCT00366704
First Posted
August 17, 2006
Last Updated
February 7, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Solvay Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00366704
Brief Title
Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
Official Title
A Multicenter, Randomized, Double-blind, Parallel-group Fixed-dose Study of the Effect on Weight of Bifeprunox Versus Risperidone in the Treatment of Outpatients With Schizophrenia.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Solvay Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
bifeprunox
Intervention Description
.25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Description
4mg, QD, 8 week treatment
Primary Outcome Measure Information:
Title
The primary analysis will be the change from baseline on body weight at the final evaluation.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.
Time Frame
8 weeks
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:
Current treatment of at least 3 months with risperidone.
Primary diagnosis of schizophrenia.
Total Positive and Negative Symptoms Scale (PANSS) score < or = 70 at screening and baseline.
Exclusion criteria:
Psychiatric diagnosis other than schizophrenia as assessed by the modified Mini International Neuropsychiatric Interview (MINI) and considered by the investigator to be the primary psychiatric diagnosis.
History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
History of any suicide attempt within 3 years of day 1 or significant immediate risk of violence or suicidality.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92802
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
City
Boynton Beach
State/Province
California
ZIP/Postal Code
33426
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92363
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
City
Rosemead
State/Province
California
ZIP/Postal Code
91770
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30307
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Coevr d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14624
Country
United States
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
City
Butner
State/Province
North Carolina
ZIP/Postal Code
27509
Country
United States
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73139
Country
United States
City
East Stroudsberg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38157
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
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