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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00396214
• Other study ID #: S154.3.021
• Secondary ID: 2006-004973-83
• Status: Terminated
• Phase: Phase 3
• First received: November 3, 2006
• Last updated: May 30, 2008
• Start date: April 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2008
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthPoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Body Weight Changes
• Schizophrenia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Argentina	Site 502	Buenos Aires
Argentina	Site 506	Buenos Aires
Argentina	Site 505	Cordoba
Argentina	Site 507	Cordoba
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
Canada	Site 400	Burlington	Ontario
Canada	Site 401	Chatham	Ontario
Canada	Site 408	Halifax	Nova Scotia
Canada	Site 409	Hull	Quebec
Canada	Site 406	Kelowna	British Columbia
Canada	Site 404	Mississauga	Ontario
Canada	Site 407	Orleans	Ontario
Canada	Site 405	Ottawa	Ontario
Canada	Site 403	Prince Albert	Saskatchewan
Canada	Site 410	Saskatoon	Saskatchewan
Canada	Site 413	Sydney
Canada	Site 411	Victoria	British Columbia
Chile	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
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 602	Praha
Czech Republic	Site 605	Praha
Estonia	Site 606	Tallinn
Estonia	Site 608	Tartu
Estonia	Site 607	Voru
Finland	Site 609	Helsinki
Finland	Site 611	Helsinki
Finland	Site 610	Turku
Germany	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
Hungary	Site 621	Balassagyarmat
Hungary	Site 623	Budapest
Hungary	Site 624	Gyor
Hungary	Site 625	Gyula
Hungary	Site 622	Pecs
Latvia	Site 627	Jelgava
Latvia	Site 628	Kaunas
Latvia	Site 626	Sigulda
Lithuania	Site 630	Silute
Lithuania	Site 629	Vilnius
Peru	Site 520	Lima
Peru	Site 521	Lima
Peru	Site 522	Lima
Peru	Site 523	Lima
Peru	Site 524	Lima
Peru	Site 525	Lima
Slovakia	Site 631	Bojnice
Slovakia	Site 634	Bratislava
Slovakia	Site 632	Liptovsky Mikulas
Slovakia	Site 635	Michalovce
Slovakia	Site 633	Rimavska Sobota
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
United States	Site 313	Anaheim	California
United States	Site 333	Anaheim	California
United States	Site 330	Atlanta	Georgia
United States	Site 308	Augusta	Georgia
United States	Site 307	Austin	Texas
United States	Site 310	Buffalo	New York
United States	Site 312	Buffalo	New York
United States	Site 306	Cedarhurst	New York
United States	Site 323	Cerritos	California
United States	Site 337	Chicago	Illinois
United States	Site 329	Cincinnati	Ohio
United States	Site 320	Clementon	New Jersey
United States	Site 347	Clementon	New Jersey
United States	Site 303	Conroe	Texas
United States	Site 374	Costa Mesa	California
United States	Site 326	Culver City	California
United States	Site 371	Darien	Connecticut
United States	Site 370	Decatur	Georgia
United States	Site 318	Denver	Colorado
United States	Site 328	Detroit	Michigan
United States	Site 301	Glen Burnie	Maryland
United States	Site 300	Glendale	California
United States	Site 358	Hartford	Connecticut
United States	Site 317	Hialeah	Florida
United States	Site 305	Houston	Texas
United States	Site 335	Indianapolis	Indiana
United States	Site 341	Lake Charles	Louisiana
United States	Site 362	Largo	Florida
United States	Site 343	Long Beach	California
United States	Site 356	Los Angeles	California
United States	Site 367	Los Angeles	California
United States	Site 352	Memphis	Tennessee
United States	Site 327	Miami	Florida
United States	Site 373	Miami	Florida
United States	Site 357	Minneapolis	Minnesota
United States	Site 360	New Britain	Connecticut
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 334	North Miami	Florida
United States	Site 351	North Miami	Florida
United States	Site 361	Oakbrook Terrace	Illinois
United States	Site 322	Oceanside	California
United States	Site 345	Oklahoma City	Oklahoma
United States	Site 368	Oklahoma City	Oklahoma
United States	Site 369	Omaha	Nebraska
United States	Site 338	Orange City	Florida
United States	Site 316	Pasadena	California
United States	Site 314	Philadelphia	Pennsylvania
United States	Site 346	Philadelphia	Pennsylvania
United States	Site 348	Philadelphia	Pennsylvania
United States	Site 354	Portland	Oregon
United States	Site 319	Richmond	Virginia
United States	Site 302	Sacramento	California
United States	Site 325	San Antonio	Texas
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 304	Shreveport	Louisiana
United States	Site 350	Sioux Falls	South Dakota
United States	Site 366	Smyma	Georgia
United States	Site 349	Spokane	Washington
United States	Site 309	St. Louis	Missouri
United States	Site 324	Staten Island	New York
United States	Site 332	Tampa	Florida
United States	Site 344	Torrance	California
United States	Site 342	Towson	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals	H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Czech Republic,  Estonia,  Finland,  Germany,  Hungary,  Latvia,  Lithuania,  Peru,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		8 weeks	Yes
Secondary	Change from baseline in Triglyceride		8 weeks	No
Secondary	Detorioration (composite definition using PANSS total score and CGI-I)		26 weeks	No
Secondary	Change from baseline in Weight, Triglyceride and Cardiovascular risk factors		52 weeks	No