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

This study has been terminated.
(This trial discontinued on 2 May 2008 due to lack of enrolment)
Sponsor:
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00396214
First received: November 3, 2006
Last updated: May 30, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Bifeprunox
Drug: Quetiapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in Triglyceride [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Detorioration (composite definition using PANSS total score and CGI-I) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Weight, Triglyceride and Cardiovascular risk factors [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Bifeprunox
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.
Experimental: 2 Drug: Bifeprunox
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.
Active Comparator: 3 Drug: Quetiapine
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396214

  Hide Study Locations
Locations
United States, California
Site 333
Anaheim, California, United States
Site 313
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 367
Los Angeles, California, United States
Site 356
Los Angeles, California, United States
Site 322
Oceanside, California, United States
Site 316
Pasadena, California, United States
Site 302
Sacramento, California, United States
Site 331
San Diego, California, United States
Site 340
San Diego, California, United States
Site 315
San Diego, California, United States
Site 336
Santa Ana, California, United States
Site 311
Santa Ana, California, United States
Site 344
Torrance, California, United States
United States, Colorado
Site 318
Denver, Colorado, United States
United States, Connecticut
Site 371
Darien, Connecticut, United States
Site 358
Hartford, Connecticut, United States
Site 360
New Britain, Connecticut, United States
United States, Florida
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
United States, Georgia
Site 330
Atlanta, Georgia, United States
Site 308
Augusta, Georgia, United States
Site 370
Decatur, Georgia, United States
Site 366
Smyma, Georgia, United States
United States, Illinois
Site 337
Chicago, Illinois, United States
Site 361
Oakbrook Terrace, Illinois, United States
United States, Indiana
Site 335
Indianapolis, Indiana, United States
United States, Louisiana
Site 341
Lake Charles, Louisiana, United States
Site 304
Shreveport, Louisiana, United States
United States, Maryland
Site 301
Glen Burnie, Maryland, United States
Site 342
Towson, Maryland, United States
United States, Michigan
Site 328
Detroit, Michigan, United States
United States, Minnesota
Site 357
Minneapolis, Minnesota, United States
United States, Missouri
Site 309
St. Louis, Missouri, United States
United States, Nebraska
Site 369
Omaha, Nebraska, United States
United States, New Jersey
Site 347
Clementon, New Jersey, United States
Site 320
Clementon, New Jersey, United States
United States, New York
Site 312
Buffalo, New York, United States
Site 310
Buffalo, New York, United States
Site 306
Cedarhurst, New York, United States
Site 321
New York, New York, United States
Site 372
New York, New York, United States
Site 353
New York, New York, United States
Site 324
Staten Island, New York, United States
United States, Ohio
Site 329
Cincinnati, Ohio, United States
United States, Oklahoma
Site 345
Oklahoma City, Oklahoma, United States
Site 368
Oklahoma City, Oklahoma, United States
United States, Oregon
Site 354
Portland, Oregon, United States
United States, Pennsylvania
Site 346
Philadelphia, Pennsylvania, United States
Site 348
Philadelphia, Pennsylvania, United States
Site 314
Philadelphia, Pennsylvania, United States
United States, South Dakota
Site 350
Sioux Falls, South Dakota, United States
United States, Tennessee
Site 352
Memphis, Tennessee, United States
United States, Texas
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
United States, Virginia
Site 319
Richmond, Virginia, United States
United States, Washington
Site 349
Spokane, Washington, United States
Argentina
Site 506
Buenos Aires, Argentina
Site 502
Buenos Aires, Argentina
Site 507
Cordoba, Argentina
Site 505
Cordoba, Argentina
Site 508
La Plata, Argentina
Site 355
Little Rock, Argentina
Site 504
Mendoza, Argentina
Site 501
Mendoza, Argentina
Site 509
Mendoza, Argentina
Site 503
Rosario, Argentina
Canada, British Columbia
Site 406
Kelowna, British Columbia, Canada
Site 411
Victoria, British Columbia, Canada
Canada, Nova Scotia
Site 408
Halifax, Nova Scotia, Canada
Canada, Ontario
Site 400
Burlington, Ontario, Canada
Site 401
Chatham, Ontario, Canada
Site 404
Mississauga, Ontario, Canada
Site 407
Orleans, Ontario, Canada
Site 405
Ottawa, Ontario, Canada
Canada, Quebec
Site 409
Hull, Quebec, Canada
Canada, Saskatchewan
Site 403
Prince Albert, Saskatchewan, Canada
Site 410
Saskatoon, Saskatchewan, Canada
Canada
Site 413
Sydney, Canada
Chile
Site 514
Coquimbo, Chile
Site 510
Santiago, Chile
Site 512
Santiago, Chile
Site 511
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
Czech Republic
Site 636
Ceske Budejovice, Czech Republic
Site 637
Kutna Hora, Czech Republic
Site 604
Litomerice, Czech Republic
Site 600
Olomouc, Czech Republic
Site 601
Plzen, Czech Republic
Site 605
Praha, Czech Republic
Site 602
Praha, Czech Republic
Estonia
Site 606
Tallinn, Estonia
Site 608
Tartu, Estonia
Site 607
Voru, Estonia
Finland
Site 609
Helsinki, Finland
Site 611
Helsinki, Finland
Site 610
Turku, Finland
Germany
Site 612
Berlin, Germany
Site 613
Berlin, Germany
Site 620
Berlin, Germany
Site 617
Berlin, Germany
Site 619
Bochum-Gerthe, Germany
Site 616
Bonn, Germany
Site 615
München, Germany
Site 618
Siegen, Germany
Hungary
Site 621
Balassagyarmat, Hungary
Site 623
Budapest, Hungary
Site 624
Gyor, Hungary
Site 625
Gyula, Hungary
Site 622
Pecs, Hungary
Latvia
Site 627
Jelgava, Latvia
Site 628
Kaunas, Latvia
Site 626
Sigulda, Latvia
Lithuania
Site 630
Silute, Lithuania
Site 629
Vilnius, Lithuania
Peru
Site 520
Lima, Peru
Site 521
Lima, Peru
Site 522
Lima, Peru
Site 523
Lima, Peru
Site 524
Lima, Peru
Site 525
Lima, Peru
Slovakia
Site 631
Bojnice, Slovakia
Site 634
Bratislava, Slovakia
Site 632
Liptovsky Mikulas, Slovakia
Site 635
Michalovce, Slovakia
Site 633
Rimavska Sobota, Slovakia
South Africa
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
Sponsors and Collaborators
Solvay Pharmaceuticals
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Loretta Stallings, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00396214     History of Changes
Other Study ID Numbers: S154.3.021, 2006-004973-83
Study First Received: November 3, 2006
Last Updated: May 30, 2008
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control

Keywords provided by Solvay Pharmaceuticals:
Schizophrenia
weight changes

Additional relevant MeSH terms:
Body Weight Changes
Schizophrenia
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 18, 2014