Study Stopped
This trial discontinued on 2 May 2008 due to lack of enrolment
Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
2 other identifiers
interventional
83
14 countries
151
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Started Apr 2007
Shorter than P25 for phase_3 schizophrenia
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2006
CompletedFirst Posted
Study publicly available on registry
November 6, 2006
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedJune 4, 2008
May 1, 2008
9 months
November 3, 2006
May 30, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
8 weeks
Secondary Outcomes (3)
Change from baseline in Triglyceride
8 weeks
Detorioration (composite definition using PANSS total score and CGI-I)
26 weeks
Change from baseline in Weight, Triglyceride and Cardiovascular risk factors
52 weeks
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of Schizophrenia
- years
- No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solvay Pharmaceuticalslead
- H. Lundbeck A/Scollaborator
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Study Sites (151)
Site 313
Anaheim, California, United States
Site 333
Anaheim, California, United States
Site 323
Cerritos, California, United States
Site 374
Costa Mesa, California, United States
Site 326
Culver City, California, United States
Site 300
Glendale, California, United States
Site 343
Long Beach, California, United States
Site 356
Los Angeles, California, United States
Site 367
Los Angeles, California, United States
Site 322
Oceanside, California, United States
Site 316
Pasadena, California, United States
Site 302
Sacramento, California, United States
Site 315
San Diego, California, United States
Site 331
San Diego, California, United States
Site 340
San Diego, California, United States
Site 311
Santa Ana, California, United States
Site 336
Santa Ana, California, United States
Site 344
Torrance, California, United States
Site 318
Denver, Colorado, United States
Site 371
Darien, Connecticut, United States
Site 358
Hartford, Connecticut, United States
Site 360
New Britain, Connecticut, United States
Site 317
Hialeah, Florida, United States
Site 362
Largo, Florida, United States
Site 327
Miami, Florida, United States
Site 373
Miami, Florida, United States
Site 334
North Miami, Florida, United States
Site 351
North Miami, Florida, United States
Site 338
Orange City, Florida, United States
Site 332
Tampa, Florida, United States
Site 330
Atlanta, Georgia, United States
Site 308
Augusta, Georgia, United States
Site 370
Decatur, Georgia, United States
Site 366
Smyma, Georgia, United States
Site 337
Chicago, Illinois, United States
Site 361
Oakbrook Terrace, Illinois, United States
Site 335
Indianapolis, Indiana, United States
Site 341
Lake Charles, Louisiana, United States
Site 304
Shreveport, Louisiana, United States
Site 301
Glen Burnie, Maryland, United States
Site 342
Towson, Maryland, United States
Site 328
Detroit, Michigan, United States
Site 357
Minneapolis, Minnesota, United States
Site 309
St Louis, Missouri, United States
Site 369
Omaha, Nebraska, United States
Site 320
Clementon, New Jersey, United States
Site 347
Clementon, New Jersey, United States
Site 310
Buffalo, New York, United States
Site 312
Buffalo, New York, United States
Site 306
Cedarhurst, New York, United States
Site 321
New York, New York, United States
Site 353
New York, New York, United States
Site 372
New York, New York, United States
Site 324
Staten Island, New York, United States
Site 329
Cincinnati, Ohio, United States
Site 345
Oklahoma City, Oklahoma, United States
Site 368
Oklahoma City, Oklahoma, United States
Site 354
Portland, Oregon, United States
Site 314
Philadelphia, Pennsylvania, United States
Site 346
Philadelphia, Pennsylvania, United States
Site 348
Philadelphia, Pennsylvania, United States
Site 350
Sioux Falls, South Dakota, United States
Site 352
Memphis, Tennessee, United States
Site 307
Austin, Texas, United States
Site 303
Conroe, Texas, United States
Site 305
Houston, Texas, United States
Site 325
San Antonio, Texas, United States
Site 319
Richmond, Virginia, United States
Site 349
Spokane, Washington, United States
Site 502
Buenos Aires, Argentina
Site 506
Buenos Aires, Argentina
Site 505
Córdoba, Argentina
Site 507
Córdoba, Argentina
Site 508
La Plata, Argentina
Site 355
Little Rock, Argentina
Site 501
Mendoza, Argentina
Site 504
Mendoza, Argentina
Site 509
Mendoza, Argentina
Site 503
Rosario, Argentina
Site 406
Kelowna, British Columbia, Canada
Site 411
Victoria, British Columbia, Canada
Site 408
Halifax, Nova Scotia, Canada
Site 400
Burlington, Ontario, Canada
Site 401
Chatham, Ontario, Canada
Site 404
Mississauga, Ontario, Canada
Site 407
Orléans, Ontario, Canada
Site 405
Ottawa, Ontario, Canada
Site 409
Hull, Quebec, Canada
Site 403
Prince Albert, Saskatchewan, Canada
Site 410
Saskatoon, Saskatchewan, Canada
Site 413
Sydney, Canada
Site 514
Coquimbo, Chile
Site 510
Santiago, Chile
Site 511
Santiago, Chile
Site 512
Santiago, Chile
Site 513
Santiago, Chile
Site 516
Santiago, Chile
Site 517
Santiago, Chile
Site 518
Santiago, Chile
Site 519
Santiago, Chile
Site 515
Valdivia, Chile
Site 636
České Budějovice, Czechia
Site 637
Kutná Hora, Czechia
Site 604
Litoměřice, Czechia
Site 600
Olomouc, Czechia
Site 601
Pilsen, Czechia
Site 602
Prague, Czechia
Site 605
Prague, Czechia
Site 606
Tallinn, Estonia
Site 608
Tartu, Estonia
Site 607
Võru, Estonia
Site 609
Helsinki, Finland
Site 611
Helsinki, Finland
Site 610
Turku, Finland
Site 612
Berlin, Germany
Site 613
Berlin, Germany
Site 617
Berlin, Germany
Site 620
Berlin, Germany
Site 619
Bochum-Gerthe, Germany
Site 616
Bonn, Germany
Site 615
München, Germany
Site 618
Siegen, Germany
Site 621
Balassagyarmat, Hungary
Site 623
Budapest, Hungary
Site 624
Győr, Hungary
Site 625
Gyula, Hungary
Site 622
Pécs, Hungary
Site 627
Jelgava, Latvia
Site 628
Kaunas, Latvia
Site 626
Sigulda, Latvia
Site 630
Šilutė, Lithuania
Site 629
Vilnius, Lithuania
Site 520
Lima, Peru
Site 521
Lima, Peru
Site 522
Lima, Peru
Site 523
Lima, Peru
Site 524
Lima, Peru
Site 525
Lima, Peru
Site 631
Bojnice, Slovakia
Site 634
Bratislava, Slovakia
Site 632
Liptovský Mikuláš, Slovakia
Site 635
Michalovce, Slovakia
Site 633
Rimavská Sobota, Slovakia
Site 707
Aucklandpark, South Africa
Site 703
Bellair, South Africa
Site 700
Cape Town, South Africa
Site 705
Cape Town, South Africa
Site 706
Cape Town, South Africa
Site 702
Johannesburg, South Africa
Site 701
Pretoria, South Africa
Site 704
Pretoria, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 3, 2006
First Posted
November 6, 2006
Study Start
April 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
June 4, 2008
Record last verified: 2008-05