Switch Study of Existing Atypical Antipsychotics to Bifeprunox

NCT ID: NCT00347425

Last Updated: 2008-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia and Schizoaffective Disorder

Keywords

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Switch Study Schizophrenia Atypical Antipsychotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type OTHER

Aripiprazole

Intervention Type DRUG

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Olanzapine

Intervention Type DRUG

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Risperidone

Intervention Type DRUG

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Quetiapine

Intervention Type DRUG

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Ziprasidone

Intervention Type DRUG

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

B

Group Type OTHER

Aripiprazole

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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Aripiprazole

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Intervention Type DRUG

Olanzapine

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Intervention Type DRUG

Risperidone

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Intervention Type DRUG

Quetiapine

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Intervention Type DRUG

Ziprasidone

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 148

Birmingham, Alabama, United States

Site Status

Site 194

Little Rock, Arkansas, United States

Site Status

Site 178

Anaheim, California, United States

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Site 167

Cerritos, California, United States

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Site 189

Cerritos, California, United States

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Site 183

Culver City, California, United States

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Site 140

Garden Grove, California, United States

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Site 162

La Palma, California, United States

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Site 190

Long Beach, California, United States

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Site 173

Oceanside, California, United States

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Site 175

Paramount, California, United States

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Site 136

Pasadena, California, United States

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Site 184

Sacramento, California, United States

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Site 152

San Diego, California, United States

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Site 186

San Diego, California, United States

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Site 133

Santa Ana, California, United States

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Site 171

Torrance, California, United States

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Site 197

Boca Raton, Florida, United States

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Site 156

Gainesville, Florida, United States

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Site 188

Hialeah, Florida, United States

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Site 193

Jacksonville, Florida, United States

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Site 154

Miami, Florida, United States

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Site 163

North Miami, Florida, United States

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Site 168

North Miami, Florida, United States

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Site 166

Orange City, Florida, United States

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Site 124

Orlando, Florida, United States

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Site 187

Tampa, Florida, United States

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Site 161

Atlanta, Georgia, United States

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Site 128

Augusta, Georgia, United States

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Site 122

Decatur, Georgia, United States

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Site 174

Chicago, Illinois, United States

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Site 164

Indianapolis, Indiana, United States

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Site 172

Lake Charles, Louisiana, United States

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Site 182

Shreveport, Louisiana, United States

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Site 121

Glen Burnie, Maryland, United States

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Site 159

Detroit, Michigan, United States

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Site 153

Minneapolis, Minnesota, United States

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Site 145

Saint Charles, Missouri, United States

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Site 130

St Louis, Missouri, United States

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Site 141

St Louis, Missouri, United States

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Site 142

Clementon, New Jersey, United States

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Site 180

Kenilworth, New Jersey, United States

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Site 129

Albuquerque, New Mexico, United States

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Site 131

Brooklyn, New York, United States

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Site 181

Cedarhurst, New York, United States

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Site 169

Jamaica, New York, United States

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Site 195

New York, New York, United States

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Site 147

Staten Island, New York, United States

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Site 127

Chagrin Falls, Ohio, United States

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Site 176

Cincinnati, Ohio, United States

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Site 191

Oklahoma City, Oklahoma, United States

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Site 146

Philadelphia, Pennsylvania, United States

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Site 179

Philadelphia, Pennsylvania, United States

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Site 196

Sioux Falls, South Dakota, United States

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Site 134

Memphis, Tennessee, United States

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Site 170

Memphis, Tennessee, United States

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Site 177

Austin, Texas, United States

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Site 185

Conroe, Texas, United States

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Site 126

Houston, Texas, United States

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Site 151

San Antonio, Texas, United States

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Site 138

Richmond, Virginia, United States

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Site 198

Spokane, Washington, United States

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Site 165

Huntington, West Virginia, United States

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Site 302

Buenos Aires, , Argentina

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Site 305

Buenos Aires, , Argentina

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Site 306

Córdoba, , Argentina

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Site 307

La Plata, , Argentina

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Site 301

Mendoza, , Argentina

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Site 304

Mendoza, , Argentina

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Site 308

Mendoza, , Argentina

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Site 303

Rosario, , Argentina

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Site 116

Chatham, Ontario, Canada

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Site 117

Mississauga, Ontario, Canada

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Site 100

Calgary, , Canada

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Site 101

Claresholm, , Canada

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Site 110

Halifax, , Canada

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Site 111

Hull, , Canada

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Site 107

Kelowna, , Canada

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Site 109

Kingston, , Canada

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Site 115

Markham, , Canada

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Site 112

Medicine Hat, , Canada

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Site 108

Orléans, , Canada

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Site 106

Ottawa, , Canada

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Site 104

Prince Albert, , Canada

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Site 102

Sherbrooke, , Canada

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Site 114

Victoria, , Canada

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Site 113

Winnipeg, , Canada

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Site 235

Bolonska, , Czechia

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Site 234

Jablonova, , Czechia

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Site 216

Litoměřice, , Czechia

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Site 233

Na Markvartce, , Czechia

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Site 213

Olomouc, , Czechia

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Site 214

Pilsen, , Czechia

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Site 215

Prague, , Czechia

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Site 217

Prague, , Czechia

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Site 236

Rejskovo Namesti, , Czechia

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Site 231

Paldksi Mnt, , Estonia

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Site 229

Tartu, , Estonia

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Site 230

Võru, , Estonia

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Site 202

Clermont-Ferrand, , France

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Site 203

Dole, , France

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Site 201

Saint-Cyr-au-Mont-d'Or, , France

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Site 206

Balassagyarmat, , Hungary

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Site 204

Budapest, , Hungary

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Site 205

Budapest, , Hungary

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Site 208

Budapest, , Hungary

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Site 211

Budapest, , Hungary

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Site 207

Debrecen, , Hungary

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Site 212

Győr, , Hungary

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Site 209

Gyula, , Hungary

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Site 210

Pécs, , Hungary

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Site 219

Balvi, , Latvia

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Site 221

Jelgava, , Latvia

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Site 218

Liepāja, , Latvia

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Site 222

Riga, , Latvia

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Site 220

Sigulda, , Latvia

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Site 225

Kaunas, , Lithuania

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Site 226

Kaunas, , Lithuania

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Site 223

Klaipėda, , Lithuania

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Site 232

Šilutė, , Lithuania

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Site 224

Vilnius, , Lithuania

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Site 228

Vilnius, , Lithuania

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Countries

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United States Argentina Canada Czechia Estonia France Hungary Latvia Lithuania

Other Identifiers

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2006-004972-11

Identifier Type: -

Identifier Source: secondary_id

S154.3.020

Identifier Type: -

Identifier Source: org_study_id