Clinical trial NCT00396214: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
weight changes
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2006-11-06
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in Triglyceride
timeFrame: 8 weeks
measure: Detorioration (composite definition using PANSS total score and CGI-I)
timeFrame: 26 weeks
measure: Change from baseline in Weight, Triglyceride and Cardiovascular risk factors
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Site 313
state: California
city: Anaheim
country: United States
facility: Site 333
state: California
city: Cerritos
country: United States
facility: Site 323
state: California
city: Costa Mesa
country: United States
facility: Site 374
state: California
city: Culver City
country: United States
facility: Site 326
state: California
city: Glendale
country: United States
facility: Site 300
state: California
city: Long Beach
country: United States
facility: Site 343
state: California
city: Los Angeles
country: United States
facility: Site 356
state: California
city: Los Angeles
country: United States
facility: Site 367
state: California
city: Oceanside
country: United States
facility: Site 322
state: California
city: Pasadena
country: United States
facility: Site 316
state: California
city: Sacramento
country: United States
facility: Site 302
state: California
city: San Diego
country: United States
facility: Site 315
state: California
city: San Diego
country: United States
facility: Site 331
state: California
city: San Diego
country: United States
facility: Site 340
state: California
city: Santa Ana
country: United States
facility: Site 311
state: California
city: Santa Ana
country: United States
facility: Site 336
state: California
city: Torrance
country: United States
facility: Site 344
state: California
city: Denver
country: United States
facility: Site 318
state: Colorado
city: Darien
country: United States
facility: Site 371
state: Connecticut
city: Hartford
country: United States
facility: Site 358
state: Connecticut
city: New Britain
country: United States
facility: Site 360
state: Connecticut
city: Hialeah
country: United States
facility: Site 317
state: Florida
city: Largo
country: United States
facility: Site 362
state: Florida
city: Miami
country: United States
facility: Site 327
state: Florida
city: Miami
country: United States
facility: Site 373
state: Florida
city: North Miami
country: United States
facility: Site 334
state: Florida
city: North Miami
country: United States
facility: Site 351
state: Florida
city: Orange City
country: United States
facility: Site 338
state: Florida
city: Tampa
country: United States
facility: Site 332
state: Florida
city: Atlanta
country: United States
facility: Site 330
state: Georgia
city: Augusta
country: United States
facility: Site 308
state: Georgia
city: Decatur
country: United States
facility: Site 370
state: Georgia
city: Smyma
country: United States
facility: Site 366
state: Georgia
city: Chicago
country: United States
facility: Site 337
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Site 361
state: Illinois
city: Indianapolis
country: United States
facility: Site 335
state: Indiana
city: Lake Charles
country: United States
facility: Site 341
state: Louisiana
city: Shreveport
country: United States
facility: Site 304
state: Louisiana
city: Glen Burnie
country: United States
facility: Site 301
state: Maryland
city: Towson
country: United States
facility: Site 342
state: Maryland
city: Detroit
country: United States
facility: Site 328
state: Michigan
city: Minneapolis
country: United States
facility: Site 357
state: Minnesota
city: St. Louis
country: United States
facility: Site 309
state: Missouri
city: Omaha
country: United States
facility: Site 369
state: Nebraska
city: Clementon
country: United States
facility: Site 320
state: New Jersey
city: Clementon
country: United States
facility: Site 347
state: New Jersey
city: Buffalo
country: United States
facility: Site 310
state: New York
city: Buffalo
country: United States
facility: Site 312
state: New York
city: Cedarhurst
country: United States
facility: Site 306
state: New York
city: New York
country: United States
facility: Site 321
state: New York
city: New York
country: United States
facility: Site 353
state: New York
city: New York
country: United States
facility: Site 372
state: New York
city: Staten Island
country: United States
facility: Site 324
state: New York
city: Cincinnati
country: United States
facility: Site 329
state: Ohio
city: Oklahoma City
country: United States
facility: Site 345
state: Oklahoma
city: Oklahoma City
country: United States
facility: Site 368
state: Oklahoma
city: Portland
country: United States
facility: Site 354
state: Oregon
city: Philadelphia
country: United States
facility: Site 314
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 346
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 348
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Site 350
state: South Dakota
city: Memphis
country: United States
facility: Site 352
state: Tennessee
city: Austin
country: United States
facility: Site 307
state: Texas
city: Conroe
country: United States
facility: Site 303
state: Texas
city: Houston
country: United States
facility: Site 305
state: Texas
city: San Antonio
country: United States
facility: Site 325
state: Texas
city: Richmond
country: United States
facility: Site 319
state: Virginia
city: Spokane
country: United States
facility: Site 349
state: Washington
city: Buenos Aires
country: Argentina
facility: Site 502
city: Buenos Aires
country: Argentina
facility: Site 506
city: Cordoba
country: Argentina
facility: Site 505
city: Cordoba
country: Argentina
facility: Site 507
city: La Plata
country: Argentina
facility: Site 508
city: Little Rock
country: Argentina
facility: Site 355
city: Mendoza
country: Argentina
facility: Site 501
city: Mendoza
country: Argentina
facility: Site 504
city: Mendoza
country: Argentina
facility: Site 509
city: Rosario
country: Argentina
facility: Site 503
city: Kelowna
country: Canada
facility: Site 406
state: British Columbia
city: Victoria
country: Canada
facility: Site 411
state: British Columbia
city: Halifax
country: Canada
facility: Site 408
state: Nova Scotia
city: Burlington
country: Canada
facility: Site 400
state: Ontario
city: Chatham
country: Canada
facility: Site 401
state: Ontario
city: Mississauga
country: Canada
facility: Site 404
state: Ontario
city: Orleans
country: Canada
facility: Site 407
state: Ontario
city: Ottawa
country: Canada
facility: Site 405
state: Ontario
city: Hull
country: Canada
facility: Site 409
state: Quebec
city: Prince Albert
country: Canada
facility: Site 403
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Site 410
state: Saskatchewan
city: Sydney
country: Canada
facility: Site 413
city: Coquimbo
country: Chile
facility: Site 514
city: Santiago
country: Chile
facility: Site 510
city: Santiago
country: Chile
facility: Site 511
city: Santiago
country: Chile
facility: Site 512
city: Santiago
country: Chile
facility: Site 513
city: Santiago
country: Chile
facility: Site 516
city: Santiago
country: Chile
facility: Site 517
city: Santiago
country: Chile
facility: Site 518
city: Santiago
country: Chile
facility: Site 519
city: Valdivia
country: Chile
facility: Site 515
city: Ceske Budejovice
country: Czech Republic
facility: Site 636
city: Kutna Hora
country: Czech Republic
facility: Site 637
city: Litomerice
country: Czech Republic
facility: Site 604
city: Olomouc
country: Czech Republic
facility: Site 600
city: Plzen
country: Czech Republic
facility: Site 601
city: Praha
country: Czech Republic
facility: Site 602
city: Praha
country: Czech Republic
facility: Site 605
city: Tallinn
country: Estonia
facility: Site 606
city: Tartu
country: Estonia
facility: Site 608
city: Voru
country: Estonia
facility: Site 607
city: Helsinki
country: Finland
facility: Site 609
city: Helsinki
country: Finland
facility: Site 611
city: Turku
country: Finland
facility: Site 610
city: Berlin
country: Germany
facility: Site 612
city: Berlin
country: Germany
facility: Site 613
city: Berlin
country: Germany
facility: Site 617
city: Berlin
country: Germany
facility: Site 620
city: Bochum-Gerthe
country: Germany
facility: Site 619
city: Bonn
country: Germany
facility: Site 616
city: München
country: Germany
facility: Site 615
city: Siegen
country: Germany
facility: Site 618
city: Balassagyarmat
country: Hungary
facility: Site 621
city: Budapest
country: Hungary
facility: Site 623
city: Gyor
country: Hungary
facility: Site 624
city: Gyula
country: Hungary
facility: Site 625
city: Pecs
country: Hungary
facility: Site 622
city: Jelgava
country: Latvia
facility: Site 627
city: Kaunas
country: Latvia
facility: Site 628
city: Sigulda
country: Latvia
facility: Site 626
city: Silute
country: Lithuania
facility: Site 630
city: Vilnius
country: Lithuania
facility: Site 629
city: Lima
country: Peru
facility: Site 520
city: Lima
country: Peru
facility: Site 521
city: Lima
country: Peru
facility: Site 522
city: Lima
country: Peru
facility: Site 523
city: Lima
country: Peru
facility: Site 524
city: Lima
country: Peru
facility: Site 525
city: Bojnice
country: Slovakia
facility: Site 631
city: Bratislava
country: Slovakia
facility: Site 634
city: Liptovsky Mikulas
country: Slovakia
facility: Site 632
city: Michalovce
country: Slovakia
facility: Site 635
city: Rimavska Sobota
country: Slovakia
facility: Site 633
city: Aucklandpark
country: South Africa
facility: Site 707
city: Bellair
country: South Africa
facility: Site 703
city: Cape Town
country: South Africa
facility: Site 700
city: Cape Town
country: South Africa
facility: Site 705
city: Cape Town
country: South Africa
facility: Site 706
city: Johannesburg
country: South Africa
facility: Site 702
city: Pretoria
country: South Africa
facility: Site 701
city: Pretoria
country: South Africa
facility: Site 704
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: