Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
- Registration Number
- NCT00396214
- Lead Sponsor
- Solvay Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 83
- Diagnosis of Schizophrenia
- 18-65 years
- No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Bifeprunox - 1 Bifeprunox - 3 Quetiapine -
- Primary Outcome Measures
Name Time Method Weight 8 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (151)
Site 311
🇺🇸Santa Ana, California, United States
Site 330
🇺🇸Atlanta, Georgia, United States
Site 370
🇺🇸Decatur, Georgia, United States
Site 324
🇺🇸Staten Island, New York, United States
Site 348
🇺🇸Philadelphia, Pennsylvania, United States
Site 411
🇨🇦Victoria, British Columbia, Canada
Site 355
🇦🇷Little Rock, Argentina
Site 507
🇦🇷Cordoba, Argentina
Site 344
🇺🇸Torrance, California, United States
Site 316
🇺🇸Pasadena, California, United States
Site 326
🇺🇸Culver City, California, United States
Site 313
🇺🇸Anaheim, California, United States
Site 343
🇺🇸Long Beach, California, United States
Site 333
🇺🇸Anaheim, California, United States
Site 308
🇺🇸Augusta, Georgia, United States
Site 374
🇺🇸Costa Mesa, California, United States
Site 367
🇺🇸Los Angeles, California, United States
Site 304
🇺🇸Shreveport, Louisiana, United States
Site 318
🇺🇸Denver, Colorado, United States
Site 323
🇺🇸Cerritos, California, United States
Site 338
🇺🇸Orange City, Florida, United States
Site 317
🇺🇸Hialeah, Florida, United States
Site 362
🇺🇸Largo, Florida, United States
Site 707
🇿🇦Aucklandpark, South Africa
Site 702
🇿🇦Johannesburg, South Africa
Site 309
🇺🇸St. Louis, Missouri, United States
Site 700
🇿🇦Cape Town, South Africa
Site 301
🇺🇸Glen Burnie, Maryland, United States
Site 372
🇺🇸New York, New York, United States
Site 508
🇦🇷La Plata, Argentina
Site 310
🇺🇸Buffalo, New York, United States
Site 510
🇨🇱Santiago, Chile
Site 633
🇸🇰Rimavska Sobota, Slovakia
Site 504
🇦🇷Mendoza, Argentina
Site 519
🇨🇱Santiago, Chile
Site 705
🇿🇦Cape Town, South Africa
Site 610
🇫🇮Turku, Finland
Site 617
🇩🇪Berlin, Germany
Site 703
🇿🇦Bellair, South Africa
Site 701
🇿🇦Pretoria, South Africa
Site 704
🇿🇦Pretoria, South Africa
Site 632
🇸🇰Liptovsky Mikulas, Slovakia
Site 635
🇸🇰Michalovce, Slovakia
Site 706
🇿🇦Cape Town, South Africa
Site 315
🇺🇸San Diego, California, United States
Site 331
🇺🇸San Diego, California, United States
Site 335
🇺🇸Indianapolis, Indiana, United States
Site 340
🇺🇸San Diego, California, United States
Site 327
🇺🇸Miami, Florida, United States
Site 373
🇺🇸Miami, Florida, United States
Site 305
🇺🇸Houston, Texas, United States
Site 624
ðŸ‡ðŸ‡ºGyor, Hungary
Site 600
🇨🇿Olomouc, Czech Republic
Site 605
🇨🇿Praha, Czech Republic
Site 607
🇪🇪Voru, Estonia
Site 634
🇸🇰Bratislava, Slovakia
Site 328
🇺🇸Detroit, Michigan, United States
Site 357
🇺🇸Minneapolis, Minnesota, United States
Site 369
🇺🇸Omaha, Nebraska, United States
Site 345
🇺🇸Oklahoma City, Oklahoma, United States
Site 368
🇺🇸Oklahoma City, Oklahoma, United States
Site 354
🇺🇸Portland, Oregon, United States
Site 332
🇺🇸Tampa, Florida, United States
Site 336
🇺🇸Santa Ana, California, United States
Site 371
🇺🇸Darien, Connecticut, United States
Site 334
🇺🇸North Miami, Florida, United States
Site 356
🇺🇸Los Angeles, California, United States
Site 358
🇺🇸Hartford, Connecticut, United States
Site 337
🇺🇸Chicago, Illinois, United States
Site 361
🇺🇸Oakbrook Terrace, Illinois, United States
Site 413
🇨🇦Sydney, Canada
Site 623
ðŸ‡ðŸ‡ºBudapest, Hungary
Site 300
🇺🇸Glendale, California, United States
Site 322
🇺🇸Oceanside, California, United States
Site 360
🇺🇸New Britain, Connecticut, United States
Site 351
🇺🇸North Miami, Florida, United States
Site 366
🇺🇸Smyma, Georgia, United States
Site 341
🇺🇸Lake Charles, Louisiana, United States
Site 306
🇺🇸Cedarhurst, New York, United States
Site 342
🇺🇸Towson, Maryland, United States
Site 312
🇺🇸Buffalo, New York, United States
Site 320
🇺🇸Clementon, New Jersey, United States
Site 347
🇺🇸Clementon, New Jersey, United States
Site 321
🇺🇸New York, New York, United States
Site 353
🇺🇸New York, New York, United States
Site 329
🇺🇸Cincinnati, Ohio, United States
Site 303
🇺🇸Conroe, Texas, United States
Site 314
🇺🇸Philadelphia, Pennsylvania, United States
Site 350
🇺🇸Sioux Falls, South Dakota, United States
Site 502
🇦🇷Buenos Aires, Argentina
Site 346
🇺🇸Philadelphia, Pennsylvania, United States
Site 506
🇦🇷Buenos Aires, Argentina
Site 325
🇺🇸San Antonio, Texas, United States
Site 352
🇺🇸Memphis, Tennessee, United States
Site 505
🇦🇷Cordoba, Argentina
Site 349
🇺🇸Spokane, Washington, United States
Site 501
🇦🇷Mendoza, Argentina
Site 509
🇦🇷Mendoza, Argentina
Site 408
🇨🇦Halifax, Nova Scotia, Canada
Site 503
🇦🇷Rosario, Argentina
Site 406
🇨🇦Kelowna, British Columbia, Canada
Site 401
🇨🇦Chatham, Ontario, Canada
Site 405
🇨🇦Ottawa, Ontario, Canada
Site 407
🇨🇦Orleans, Ontario, Canada
Site 400
🇨🇦Burlington, Ontario, Canada
Site 409
🇨🇦Hull, Quebec, Canada
Site 404
🇨🇦Mississauga, Ontario, Canada
Site 517
🇨🇱Santiago, Chile
Site 514
🇨🇱Coquimbo, Chile
Site 636
🇨🇿Ceske Budejovice, Czech Republic
Site 604
🇨🇿Litomerice, Czech Republic
Site 601
🇨🇿Plzen, Czech Republic
Site 608
🇪🇪Tartu, Estonia
Site 613
🇩🇪Berlin, Germany
Site 609
🇫🇮Helsinki, Finland
Site 612
🇩🇪Berlin, Germany
Site 618
🇩🇪Siegen, Germany
Site 620
🇩🇪Berlin, Germany
Site 616
🇩🇪Bonn, Germany
Site 619
🇩🇪Bochum-Gerthe, Germany
Site 615
🇩🇪München, Germany
Site 621
ðŸ‡ðŸ‡ºBalassagyarmat, Hungary
Site 622
ðŸ‡ðŸ‡ºPecs, Hungary
Site 520
🇵🇪Lima, Peru
Site 626
🇱🇻Sigulda, Latvia
Site 630
🇱🇹Silute, Lithuania
Site 522
🇵🇪Lima, Peru
Site 521
🇵🇪Lima, Peru
Site 523
🇵🇪Lima, Peru
Site 524
🇵🇪Lima, Peru
Site 525
🇵🇪Lima, Peru
Site 403
🇨🇦Prince Albert, Saskatchewan, Canada
Site 518
🇨🇱Santiago, Chile
Site 627
🇱🇻Jelgava, Latvia
Site 629
🇱🇹Vilnius, Lithuania
Site 631
🇸🇰Bojnice, Slovakia
Site 515
🇨🇱Valdivia, Chile
Site 513
🇨🇱Santiago, Chile
Site 516
🇨🇱Santiago, Chile
Site 637
🇨🇿Kutna Hora, Czech Republic
Site 611
🇫🇮Helsinki, Finland
Site 625
ðŸ‡ðŸ‡ºGyula, Hungary
Site 628
🇱🇻Kaunas, Latvia
Site 512
🇨🇱Santiago, Chile
Site 602
🇨🇿Praha, Czech Republic
Site 511
🇨🇱Santiago, Chile
Site 606
🇪🇪Tallinn, Estonia
Site 302
🇺🇸Sacramento, California, United States
Site 307
🇺🇸Austin, Texas, United States
Site 319
🇺🇸Richmond, Virginia, United States
Site 410
🇨🇦Saskatoon, Saskatchewan, Canada