Study Stopped
Interim analysis showed inadequate efficacy of bifeprunox
Efficacy of Bifeprunox in Patients With Schizophrenia
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
2 other identifiers
interventional
346
7 countries
45
Brief Summary
The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Jun 2008
Shorter than P25 for phase_3 schizophrenia
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 24, 2008
CompletedFirst Posted
Study publicly available on registry
June 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedSeptember 27, 2010
September 1, 2010
1.2 years
June 24, 2008
September 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).
12 weeks
Secondary Outcomes (1)
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.
12 months
Study Arms (3)
Bifeprunox
EXPERIMENTALPlacebo
PLACEBO COMPARATORQuetiapine
ACTIVE COMPARATORInterventions
20 mg daily, encapsulated tablets, orally, 12 months
600 mg daily, encapsulated tablets, orally, 12 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (45)
IN008
Ahmedabad, 380006, India
IN011
Ahmedabad, 380013, India
IN009
Aurangabad, 431005, India
IN003
Bangalore, 560002, India
IN006
Chennai, 600003, India
IN007
Kanpur, 208005, India
IN002
Lucknow, 226003, India
IN001
Mangalore, 575018, India
IN010
Varanasi, 221005, India
IN005
Visakhapatnam, 530017, India
ID002
Bangli, 80613, Indonesia
ID001
Jakarta, 10430, Indonesia
ID003
Kabupaten Bandung, 40551, Indonesia
MY005
Johor Bahru, Johor, Malaysia
MY001
Kuala Lumpur, 50603, Malaysia
MY004
Kuala Lumpur, 55100, Malaysia
MY003
Perak, 31250, Malaysia
PH004
Cebu City, 6000, Philippines
PH001
Mandaluyong, 1553, Philippines
PH002
Manila, 1000, Philippines
PH003
Pasig, 1607, Philippines
PH005
Quezon City, 0870, Philippines
PL005
Choroszcz, 16-070, Poland
PL007
Kutno, Poland
PL002
Leszno, 64-100, Poland
PL004
Lodz, 91-229, Poland
PL003
Lublin, 20-109, Poland
PL008
Skorzewo, 60-185, Poland
PL006
Swicie n/Wisla, 86-100, Poland
PL001
Torun, 87-100, Poland
KR004
Busan, 614-735, South Korea
KR008
Gyeongnam, 626-770, South Korea
KR005
Pusan, 602-739, South Korea
KR006
Seoul, 143-711, South Korea
KR001
Seoul, 150-713, South Korea
KR007
South Korea, 200-704, South Korea
UA008
Dnipropetrovsk, 49005, Ukraine
UA009
Donetsk, 83037, Ukraine
UA006
Kharkiv, 61068, Ukraine
UA003
Kyiv, 04080, Ukraine
UA004
Lviv, 79021, Ukraine
UA011
Odesa, 65006, Ukraine
UA005
Poltava, 36024, Ukraine
UA007
Stepanovka, Kherson, 73488, Ukraine
UA010
Vinnitsa, 21018, Ukraine
Related Publications (1)
Ceraso A, Lin JJ, Schneider-Thoma J, Siafis S, Tardy M, Komossa K, Heres S, Kissling W, Davis JM, Leucht S. Maintenance treatment with antipsychotic drugs for schizophrenia. Cochrane Database Syst Rev. 2020 Aug 11;8(8):CD008016. doi: 10.1002/14651858.CD008016.pub3.
PMID: 32840872DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 24, 2008
First Posted
June 25, 2008
Study Start
June 1, 2008
Primary Completion
August 1, 2009
Study Completion
November 1, 2009
Last Updated
September 27, 2010
Record last verified: 2010-09