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
227
8 countries
38
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 P25-P50 for phase_3 schizophrenia
Started Mar 2008
38 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
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 9, 2008
CompletedFirst Posted
Study publicly available on registry
April 15, 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
1.4 years
April 9, 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 (38)
BG002
Radnevo, 6260, Bulgaria
BG003
Radnevo, 6260, Bulgaria
CN009
Beijing, 100083, China
CN008
Beijing, 100088, China
GR001
Marousi, 15126, Greece
GR003
Tripoli, 22100, Greece
RO004
Brasov, 500123, Romania
RO001
Bucharest, 041914, Romania
RO002
Bucharest, 041914, Romania
RO003
Bucharest, 041914, Romania
RO009
Bucharest, 41914, Romania
RO008
Iași, 700265, Romania
RO005
Piteşti, 110069, Romania
RO007
Sibiu, 550082, Romania
RO006
Târgovişte, 130081, Romania
RU003
Arkhangelsk, 163060, Russia
RU017
Chita, 672090, Russia
RU001
Moscow, 115522, Russia
RU005
Moscow, 117152, Russia
RU009
Saint Petersburg, 190005, Russia
RU013
Saint Petersburg, 190005, Russia
RU012
Saint Petersburg, 190013, Russia
RU011
Saint Petersburg, 191119, Russia
RU004
Saint Petersburg, 193019, Russia
RU010
Saint Petersburg, 193019, Russia
RU014
Saint Petersburg, 193167, Russia
RU002
Saratov, 410012, Russia
RU015
Tomsk, 634014, Russia
TW001
Hualien Town, 970, Taiwan
TW003
Taipei, 115, Taiwan
TH002
Bangkok, 10330, Thailand
TH001
Bangkok, 10600, Thailand
TH003
Chiang Mai, 50200, Thailand
TH004
Chiang Mai, 50200, Thailand
UA002
Hlevakha, 8630, Ukraine
UA001
Kyiv, 02660, Ukraine
UA013
Kyiv, 4655, Ukraine
UA012
Luhansk, 91045, 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
April 9, 2008
First Posted
April 15, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2009
Study Completion
November 1, 2009
Last Updated
September 27, 2010
Record last verified: 2010-09