- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00704509
Efficacy of Bifeprunox in Patients With Schizophrenia
September 24, 2010 updated by: H. Lundbeck A/S
A Multinational, Randomised, Double-Blind, Fixed-Dose, Bifeprunox Study Combining a 12-Week Placebo-Controlled, Quetiapine-Referenced Phase With a 12-Month Quetiapine-Controlled Phase in Patients With Schizophrenia
The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population.
There are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited.
In particular, after having overcome acute exacerbations many patients continue to experience significant symptoms that prevent an adequate functioning.
In the current study, patients suffering from schizophrenia and currently in a post-acute maintenance phase of the disease will be included.
Non-treatment resistant patients will be included in the study, since they have partially responded to their current antipsychotic treatment but still have clinically significant symptoms and/or impairment of functioning in their daily life.
The study is a 12-month study with an initial 12-week placebo-controlled, quetiapine-referenced phase.
After this initial 12-week phase, the patients allocated to placebo will be switched to bifeprunox.
In the final non-inferiority analysis of the 12-month data, the results from this study will be combined with the data from a similar study (11915A).
Study Type
Interventional
Enrollment (Actual)
346
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ahmedabad, India, 380006
- IN008
-
Ahmedabad, India, 380013
- IN011
-
Aurangabad, India, 431005
- IN009
-
Bangalore, India, 560002
- IN003
-
Chennai, India, 600003
- IN006
-
Kanpur, India, 208005
- IN007
-
Lucknow, India, 226003
- IN002
-
Mangalore, India, 575018
- IN001
-
Varanasi, India, 221005
- IN010
-
Visakhapatnam, India, 530017
- IN005
-
-
-
-
-
Bangli, Indonesia, 80613
- ID002
-
Jakarta, Indonesia, 10430
- ID001
-
Kabupaten Bandung, Indonesia, 40551
- ID003
-
-
-
-
-
Busan, Korea, Republic of, 614-735
- KR004
-
Gyeongnam, Korea, Republic of, 626-770
- KR008
-
Pusan, Korea, Republic of, 602-739
- KR005
-
Seoul, Korea, Republic of, 143-711
- KR006
-
Seoul, Korea, Republic of, 150-713
- KR001
-
South Korea, Korea, Republic of, 200-704
- KR007
-
-
-
-
-
Johor Bahru, Malaysia, Johor
- MY005
-
Kuala Lumpur, Malaysia, 50603
- MY001
-
Kuala Lumpur, Malaysia, 55100
- MY004
-
Perak, Malaysia, 31250
- MY003
-
-
-
-
-
Cebu City, Philippines, 6000
- PH004
-
Mandaluyong City, Philippines, 1553
- PH001
-
Manila, Philippines, 1000
- PH002
-
Pasig City, Philippines, 1607
- PH003
-
Quezon City, Philippines, 0870
- PH005
-
-
-
-
-
Choroszcz, Poland, 16-070
- PL005
-
Kutno, Poland
- PL007
-
Leszno, Poland, 64-100
- PL002
-
Lodz, Poland, 91-229
- PL004
-
Lublin, Poland, 20-109
- PL003
-
Skorzewo, Poland, 60-185
- PL008
-
Swicie n/Wisla, Poland, 86-100
- PL006
-
Torun, Poland, 87-100
- PL001
-
-
-
-
-
Dnipropetrovsk, Ukraine, 49005
- UA008
-
Donetsk, Ukraine, 83037
- UA009
-
Kharkiv, Ukraine, 61068
- UA006
-
Kyiv, Ukraine, 04080
- UA003
-
Lviv, Ukraine, 79021
- UA004
-
Odessa, Ukraine, 65006
- UA011
-
Poltava, Ukraine, 36024
- UA005
-
Stepanovka, Kherson, Ukraine, 73488
- UA007
-
Vinnitsa, Ukraine, 21018
- UA010
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Main inclusion criteria
- The subject has a primary diagnosis of schizophrenia
- The subject experiences clinically significant symptoms
- The subject's medication remained stable for 8 weeks prior to screening
- The subject is currently in the post-acute maintenance phase of his/her disease
Exclusion Criteria:
Main exclusion criteria
- The subject is at significant risk of suicide
- The subject is treatment resistant
- The subject has experienced an acute exacerbation within 8 weeks prior screening
- The subject is unlikely to comply with the protocol
- The subject has a current diagnosis or a history of substance abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Encapsulated tablets, orally, 12 weeks
|
Experimental: Bifeprunox
|
20 mg daily, encapsulated tablets, orally, 12 months
Other Names:
|
Active Comparator: Quetiapine
|
600 mg daily, encapsulated tablets, orally, 12 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference in PANSS score at the 12-month time point between bifeprunox and quetiapine. Also, responder rate, time to response/withdrawal, global clinical assessments (CGI), assessment of depressive symptoms (CDSS) and health economic assessments.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
June 24, 2008
First Submitted That Met QC Criteria
June 24, 2008
First Posted (Estimate)
June 25, 2008
Study Record Updates
Last Update Posted (Estimate)
September 27, 2010
Last Update Submitted That Met QC Criteria
September 24, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11916A
- 2007-001098-27 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Rakitzi, StavroulaActive, not recruiting
-
Peking UniversityNot yet recruitingTreatment-resistant Schizophrenia
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
Clinical Trials on Bifeprunox
-
Solvay PharmaceuticalsWyeth is now a wholly owned subsidiary of Pfizer; H. Lundbeck A/SCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Solvay PharmaceuticalsWyeth is now a wholly owned subsidiary of Pfizer; H. Lundbeck A/SCompletedSchizophrenia | Schizoaffective Disorder | Bipolar DisorderUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerTerminated
-
Wyeth is now a wholly owned subsidiary of PfizerSolvay PharmaceuticalsCompleted
-
Solvay PharmaceuticalsWyeth is now a wholly owned subsidiary of Pfizer; H. Lundbeck A/SCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
H. Lundbeck A/SSolvay PharmaceuticalsTerminated
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
Solvay PharmaceuticalsTerminatedPsychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's TypeUnited States, Czech Republic, Estonia, Israel, Poland