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Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bifeprunox
Quetiapine
Bifeprunox
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, weight changes

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of Schizophrenia
  • 18-65 years
  • No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period

Exclusion Criteria:

  • Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
  • At significant risk of suicide, and the potential for violent behavior (likely to harm themselves or others) based on history

Sites / Locations

  • Site 313
  • Site 333
  • Site 323
  • Site 374
  • Site 326
  • Site 300
  • Site 343
  • Site 356
  • Site 367
  • Site 322
  • Site 316
  • Site 302
  • Site 315
  • Site 331
  • Site 340
  • Site 311
  • Site 336
  • Site 344
  • Site 318
  • Site 371
  • Site 358
  • Site 360
  • Site 317
  • Site 362
  • Site 327
  • Site 373
  • Site 334
  • Site 351
  • Site 338
  • Site 332
  • Site 330
  • Site 308
  • Site 370
  • Site 366
  • Site 337
  • Site 361
  • Site 335
  • Site 341
  • Site 304
  • Site 301
  • Site 342
  • Site 328
  • Site 357
  • Site 309
  • Site 369
  • Site 320
  • Site 347
  • Site 310
  • Site 312
  • Site 306
  • Site 321
  • Site 353
  • Site 372
  • Site 324
  • Site 329
  • Site 345
  • Site 368
  • Site 354
  • Site 314
  • Site 346
  • Site 348
  • Site 350
  • Site 352
  • Site 307
  • Site 303
  • Site 305
  • Site 325
  • Site 319
  • Site 349
  • Site 502
  • Site 506
  • Site 505
  • Site 507
  • Site 508
  • Site 355
  • Site 501
  • Site 504
  • Site 509
  • Site 503
  • Site 406
  • Site 411
  • Site 408
  • Site 400
  • Site 401
  • Site 404
  • Site 407
  • Site 405
  • Site 409
  • Site 403
  • Site 410
  • Site 413
  • Site 514
  • Site 510
  • Site 511
  • Site 512
  • Site 513
  • Site 516
  • Site 517
  • Site 518
  • Site 519
  • Site 515
  • Site 636
  • Site 637
  • Site 604
  • Site 600
  • Site 601
  • Site 602
  • Site 605
  • Site 606
  • Site 608
  • Site 607
  • Site 609
  • Site 611
  • Site 610
  • Site 612
  • Site 613
  • Site 617
  • Site 620
  • Site 619
  • Site 616
  • Site 615
  • Site 618
  • Site 621
  • Site 623
  • Site 624
  • Site 625
  • Site 622
  • Site 627
  • Site 628
  • Site 626
  • Site 630
  • Site 629
  • Site 520
  • Site 521
  • Site 522
  • Site 523
  • Site 524
  • Site 525
  • Site 631
  • Site 634
  • Site 632
  • Site 635
  • Site 633
  • Site 707
  • Site 703
  • Site 700
  • Site 705
  • Site 706
  • Site 702
  • Site 701
  • Site 704

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Weight

Secondary Outcome Measures

Change from baseline in Triglyceride
Detorioration (composite definition using PANSS total score and CGI-I)
Change from baseline in Weight, Triglyceride and Cardiovascular risk factors

Full Information

First Posted
November 3, 2006
Last Updated
May 30, 2008
Sponsor
Solvay Pharmaceuticals
Collaborators
H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00396214
Brief Title
Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
Official Title
A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
This trial discontinued on 2 May 2008 due to lack of enrolment
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals
Collaborators
H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, weight changes

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bifeprunox
Intervention Description
52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.
Intervention Type
Drug
Intervention Name(s)
Bifeprunox
Intervention Description
52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
Primary Outcome Measure Information:
Title
Weight
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Triglyceride
Time Frame
8 weeks
Title
Detorioration (composite definition using PANSS total score and CGI-I)
Time Frame
26 weeks
Title
Change from baseline in Weight, Triglyceride and Cardiovascular risk factors
Time Frame
52 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: Diagnosis of Schizophrenia 18-65 years No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period Exclusion Criteria: Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric diagnosis other than schizophrenia At significant risk of suicide, and the potential for violent behavior (likely to harm themselves or others) based on history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 313
City
Anaheim
State/Province
California
Country
United States
Facility Name
Site 333
City
Anaheim
State/Province
California
Country
United States
Facility Name
Site 323
City
Cerritos
State/Province
California
Country
United States
Facility Name
Site 374
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
Site 326
City
Culver City
State/Province
California
Country
United States
Facility Name
Site 300
City
Glendale
State/Province
California
Country
United States
Facility Name
Site 343
City
Long Beach
State/Province
California
Country
United States
Facility Name
Site 356
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site 367
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site 322
City
Oceanside
State/Province
California
Country
United States
Facility Name
Site 316
City
Pasadena
State/Province
California
Country
United States
Facility Name
Site 302
City
Sacramento
State/Province
California
Country
United States
Facility Name
Site 315
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 331
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 340
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 311
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 336
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 344
City
Torrance
State/Province
California
Country
United States
Facility Name
Site 318
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Site 371
City
Darien
State/Province
Connecticut
Country
United States
Facility Name
Site 358
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Site 360
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Site 317
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Site 362
City
Largo
State/Province
Florida
Country
United States
Facility Name
Site 327
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 373
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 334
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Site 351
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Site 338
City
Orange City
State/Province
Florida
Country
United States
Facility Name
Site 332
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site 330
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 308
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Site 370
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Site 366
City
Smyma
State/Province
Georgia
Country
United States
Facility Name
Site 337
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 361
City
Oakbrook Terrace
State/Province
Illinois
Country
United States
Facility Name
Site 335
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Site 341
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Site 304
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Site 301
City
Glen Burnie
State/Province
Maryland
Country
United States
Facility Name
Site 342
City
Towson
State/Province
Maryland
Country
United States
Facility Name
Site 328
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Site 357
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Site 309
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 369
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Site 320
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Site 347
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Site 310
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Site 312
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Site 306
City
Cedarhurst
State/Province
New York
Country
United States
Facility Name
Site 321
City
New York
State/Province
New York
Country
United States
Facility Name
Site 353
City
New York
State/Province
New York
Country
United States
Facility Name
Site 372
City
New York
State/Province
New York
Country
United States
Facility Name
Site 324
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Site 329
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 345
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site 368
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site 354
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Site 314
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 346
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 348
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 350
City
Sioux Falls
State/Province
South Dakota
Country
United States
Facility Name
Site 352
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Site 307
City
Austin
State/Province
Texas
Country
United States
Facility Name
Site 303
City
Conroe
State/Province
Texas
Country
United States
Facility Name
Site 305
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 325
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 319
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Site 349
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Site 502
City
Buenos Aires
Country
Argentina
Facility Name
Site 506
City
Buenos Aires
Country
Argentina
Facility Name
Site 505
City
Cordoba
Country
Argentina
Facility Name
Site 507
City
Cordoba
Country
Argentina
Facility Name
Site 508
City
La Plata
Country
Argentina
Facility Name
Site 355
City
Little Rock
Country
Argentina
Facility Name
Site 501
City
Mendoza
Country
Argentina
Facility Name
Site 504
City
Mendoza
Country
Argentina
Facility Name
Site 509
City
Mendoza
Country
Argentina
Facility Name
Site 503
City
Rosario
Country
Argentina
Facility Name
Site 406
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Site 411
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Site 408
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Site 400
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
Site 401
City
Chatham
State/Province
Ontario
Country
Canada
Facility Name
Site 404
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Site 407
City
Orleans
State/Province
Ontario
Country
Canada
Facility Name
Site 405
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Site 409
City
Hull
State/Province
Quebec
Country
Canada
Facility Name
Site 403
City
Prince Albert
State/Province
Saskatchewan
Country
Canada
Facility Name
Site 410
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Site 413
City
Sydney
Country
Canada
Facility Name
Site 514
City
Coquimbo
Country
Chile
Facility Name
Site 510
City
Santiago
Country
Chile
Facility Name
Site 511
City
Santiago
Country
Chile
Facility Name
Site 512
City
Santiago
Country
Chile
Facility Name
Site 513
City
Santiago
Country
Chile
Facility Name
Site 516
City
Santiago
Country
Chile
Facility Name
Site 517
City
Santiago
Country
Chile
Facility Name
Site 518
City
Santiago
Country
Chile
Facility Name
Site 519
City
Santiago
Country
Chile
Facility Name
Site 515
City
Valdivia
Country
Chile
Facility Name
Site 636
City
Ceske Budejovice
Country
Czech Republic
Facility Name
Site 637
City
Kutna Hora
Country
Czech Republic
Facility Name
Site 604
City
Litomerice
Country
Czech Republic
Facility Name
Site 600
City
Olomouc
Country
Czech Republic
Facility Name
Site 601
City
Plzen
Country
Czech Republic
Facility Name
Site 602
City
Praha
Country
Czech Republic
Facility Name
Site 605
City
Praha
Country
Czech Republic
Facility Name
Site 606
City
Tallinn
Country
Estonia
Facility Name
Site 608
City
Tartu
Country
Estonia
Facility Name
Site 607
City
Voru
Country
Estonia
Facility Name
Site 609
City
Helsinki
Country
Finland
Facility Name
Site 611
City
Helsinki
Country
Finland
Facility Name
Site 610
City
Turku
Country
Finland
Facility Name
Site 612
City
Berlin
Country
Germany
Facility Name
Site 613
City
Berlin
Country
Germany
Facility Name
Site 617
City
Berlin
Country
Germany
Facility Name
Site 620
City
Berlin
Country
Germany
Facility Name
Site 619
City
Bochum-Gerthe
Country
Germany
Facility Name
Site 616
City
Bonn
Country
Germany
Facility Name
Site 615
City
München
Country
Germany
Facility Name
Site 618
City
Siegen
Country
Germany
Facility Name
Site 621
City
Balassagyarmat
Country
Hungary
Facility Name
Site 623
City
Budapest
Country
Hungary
Facility Name
Site 624
City
Gyor
Country
Hungary
Facility Name
Site 625
City
Gyula
Country
Hungary
Facility Name
Site 622
City
Pecs
Country
Hungary
Facility Name
Site 627
City
Jelgava
Country
Latvia
Facility Name
Site 628
City
Kaunas
Country
Latvia
Facility Name
Site 626
City
Sigulda
Country
Latvia
Facility Name
Site 630
City
Silute
Country
Lithuania
Facility Name
Site 629
City
Vilnius
Country
Lithuania
Facility Name
Site 520
City
Lima
Country
Peru
Facility Name
Site 521
City
Lima
Country
Peru
Facility Name
Site 522
City
Lima
Country
Peru
Facility Name
Site 523
City
Lima
Country
Peru
Facility Name
Site 524
City
Lima
Country
Peru
Facility Name
Site 525
City
Lima
Country
Peru
Facility Name
Site 631
City
Bojnice
Country
Slovakia
Facility Name
Site 634
City
Bratislava
Country
Slovakia
Facility Name
Site 632
City
Liptovsky Mikulas
Country
Slovakia
Facility Name
Site 635
City
Michalovce
Country
Slovakia
Facility Name
Site 633
City
Rimavska Sobota
Country
Slovakia
Facility Name
Site 707
City
Aucklandpark
Country
South Africa
Facility Name
Site 703
City
Bellair
Country
South Africa
Facility Name
Site 700
City
Cape Town
Country
South Africa
Facility Name
Site 705
City
Cape Town
Country
South Africa
Facility Name
Site 706
City
Cape Town
Country
South Africa
Facility Name
Site 702
City
Johannesburg
Country
South Africa
Facility Name
Site 701
City
Pretoria
Country
South Africa
Facility Name
Site 704
City
Pretoria
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

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