Switch Study of Existing Atypical Antipsychotics to Bifeprunox

Schizophrenia and Schizoaffective Disorder Clinical Trial

Official title:

A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347425
• Other study ID #: S154.3.020
• Secondary ID: 2006-004972-11
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2006
• Last updated: May 20, 2008
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: May 2008
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated

Exclusion Criteria:

• Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia
• Schizophrenia and Schizoaffective Disorder

Intervention

Drug:
• Aripiprazole
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
• Olanzapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
• Risperidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
• Quetiapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
• Ziprasidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
• Aripiprazole
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
• Olanzapine
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
• Risperidone
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
• Quetiapine
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
• Ziprasidone
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days

Locations

Country	Name	City	State
Argentina	Site 302	Buenos Aires
Argentina	Site 305	Buenos Aires
Argentina	Site 306	Cordoba
Argentina	Site 307	La Plata
Argentina	Site 301	Mendoza
Argentina	Site 304	Mendoza
Argentina	Site 308	Mendoza
Argentina	Site 303	Rosario
Canada	Site 100	Calgary
Canada	Site 116	Chatham	Ontario
Canada	Site 101	Claresholm
Canada	Site 110	Halifax
Canada	Site 111	Hull
Canada	Site 107	Kelowna
Canada	Site 109	Kingston
Canada	Site 115	Markham
Canada	Site 112	Medicine Hat
Canada	Site 117	Mississauga	Ontario
Canada	Site 108	Orleans
Canada	Site 106	Ottawa
Canada	Site 104	Prince Albert
Canada	Site 102	Sherbrooke
Canada	Site 114	Victoria
Canada	Site 113	Winnipeg
Czech Republic	Site 235	Bolonska
Czech Republic	Site 234	Jablonova
Czech Republic	Site 216	Litomerice
Czech Republic	Site 233	Na Markvartce
Czech Republic	Site 213	Olomouc
Czech Republic	Site 214	Plzen
Czech Republic	Site 217	Prague
Czech Republic	Site 215	Praha
Czech Republic	Site 236	Rejskovo namesti
Estonia	Site 231	Paldksi Mnt
Estonia	Site 229	Tartu
Estonia	Site 230	Voru
France	Site 202	Clermont Ferrand
France	Site 203	Dole
France	Site 201	St. Cyr au Mont d Or
Hungary	Site 206	Balassagyarmat
Hungary	Site 204	Budapest
Hungary	Site 205	Budapest
Hungary	Site 208	Budapest
Hungary	Site 211	Budapest
Hungary	Site 207	Debrecen
Hungary	Site 212	Gyor
Hungary	Site 209	Gyula
Hungary	Site 210	Pecs
Latvia	Site 219	Balvi
Latvia	Site 221	Jelgava
Latvia	Site 218	Liepaja
Latvia	Site 222	Riga
Latvia	Site 220	Sigulda
Lithuania	Site 225	Kaunas
Lithuania	Site 226	Kaunas
Lithuania	Site 223	Klaipeda
Lithuania	Site 232	Silute
Lithuania	Site 224	Vilnius
Lithuania	Site 228	Vilnius
United States	Site 129	Albuquerque	New Mexico
United States	Site 178	Anaheim	California
United States	Site 161	Atlanta	Georgia
United States	Site 128	Augusta	Georgia
United States	Site 177	Austin	Texas
United States	Site 148	Birmingham	Alabama
United States	Site 197	Boca Raton	Florida
United States	Site 131	Brooklyn	New York
United States	Site 181	Cedarhurst	New York
United States	Site 167	Cerritos	California
United States	Site 189	Cerritos	California
United States	Site 127	Chagrin Falls	Ohio
United States	Site 174	Chicago	Illinois
United States	Site 176	Cincinnati	Ohio
United States	Site 142	Clementon	New Jersey
United States	Site 185	Conroe	Texas
United States	Site 183	Culver City	California
United States	Site 122	Decatur	Georgia
United States	Site 159	Detroit	Michigan
United States	Site 156	Gainesville	Florida
United States	Site 140	Garden Grove	California
United States	Site 121	Glen Burnie	Maryland
United States	Site 188	Hialeah	Florida
United States	Site 126	Houston	Texas
United States	Site 165	Huntington	West Virginia
United States	Site 164	Indianapolis	Indiana
United States	Site 193	Jacksonville	Florida
United States	Site 169	Jamaica	New York
United States	Site 180	Kenilworth	New Jersey
United States	Site 162	La Palma	California
United States	Site 172	Lake Charles	Louisiana
United States	Site 194	Little Rock	Arkansas
United States	Site 190	Long Beach	California
United States	Site 134	Memphis	Tennessee
United States	Site 170	Memphis	Tennessee
United States	Site 154	Miami	Florida
United States	Site 153	Minneapolis	Minnesota
United States	Site 195	New York	New York
United States	Site 163	North Miami	Florida
United States	Site 168	North Miami	Florida
United States	Site 173	Oceanside	California
United States	Site 191	Oklahoma City	Oklahoma
United States	Site 166	Orange City	Florida
United States	Site 124	Orlando	Florida
United States	Site 175	Paramount	California
United States	Site 136	Pasadena	California
United States	Site 146	Philadelphia	Pennsylvania
United States	Site 179	Philadelphia	Pennsylvania
United States	Site 138	Richmond	Virginia
United States	Site 184	Sacramento	California
United States	Site 151	San Antonio	Texas
United States	Site 152	San Diego	California
United States	Site 186	San Diego	California
United States	Site 133	Santa Ana	California
United States	Site 182	Shreveport	Louisiana
United States	Site 196	Sioux Falls	South Dakota
United States	Site 198	Spokane	Washington
United States	Site 145	St. Charles	Missouri
United States	Site 130	St. Louis	Missouri
United States	Site 141	St. Louis	Missouri
United States	Site 147	Staten Island	New York
United States	Site 187	Tampa	Florida
United States	Site 171	Torrance	California

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,  Czech Republic,  Estonia,  France,  Hungary,  Latvia,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful switch defined as those who complete the 4 weeks core study with no worsening of 2 successive post baseline assessments on the CGIS, exacerbation of EPS, or cardiovascular risk factors (body weight and fasting triglycerides) from baseline.		4 weeks	Yes
Secondary	Adverse events		4 weeks	Yes
Secondary	Adverse events		26 weeks	Yes