Clinical trial NCT00704509: Efficacy of Bifeprunox in Patients With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic
Bifeprunox
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.

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).

Eligibility criteria: 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

Primary outcomes:
measure: The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: IN008
city: Ahmedabad
country: India
facility: IN011
city: Aurangabad
country: India
facility: IN009
city: Bangalore
country: India
facility: IN003
city: Chennai
country: India
facility: IN006
city: Kanpur
country: India
facility: IN007
city: Lucknow
country: India
facility: IN002
city: Mangalore
country: India
facility: IN001
city: Varanasi
country: India
facility: IN010
city: Visakhapatnam
country: India
facility: IN005
city: Bangli
country: Indonesia
facility: ID002
city: Jakarta
country: Indonesia
facility: ID001
city: Kabupaten Bandung
country: Indonesia
facility: ID003
city: Busan
country: Korea, Republic of
facility: KR004
city: Gyeongnam
country: Korea, Republic of
facility: KR008
city: Pusan
country: Korea, Republic of
facility: KR005
city: Seoul
country: Korea, Republic of
facility: KR006
city: Seoul
country: Korea, Republic of
facility: KR001
city: South Korea
country: Korea, Republic of
facility: KR007
city: Johor Bahru
country: Malaysia
facility: MY005
city: Kuala Lumpur
country: Malaysia
facility: MY001
city: Kuala Lumpur
country: Malaysia
facility: MY004
city: Perak
country: Malaysia
facility: MY003
city: Cebu City
country: Philippines
facility: PH004
city: Mandaluyong City
country: Philippines
facility: PH001
city: Manila
country: Philippines
facility: PH002
city: Pasig City
country: Philippines
facility: PH003
city: Quezon City
country: Philippines
facility: PH005
city: Choroszcz
country: Poland
facility: PL005
city: Kutno
country: Poland
facility: PL007
city: Leszno
country: Poland
facility: PL002
city: Lodz
country: Poland
facility: PL004
city: Lublin
country: Poland
facility: PL003
city: Skorzewo
country: Poland
facility: PL008
city: Swicie n/Wisla
country: Poland
facility: PL006
city: Torun
country: Poland
facility: PL001
city: Dnipropetrovsk
country: Ukraine
facility: UA008
city: Donetsk
country: Ukraine
facility: UA009
city: Kharkiv
country: Ukraine
facility: UA006
city: Kyiv
country: Ukraine
facility: UA003
city: Lviv
country: Ukraine
facility: UA004
city: Odessa
country: Ukraine
facility: UA011
city: Poltava
country: Ukraine
facility: UA005
city: Stepanovka, Kherson
country: Ukraine
facility: UA007
city: Vinnitsa
country: Ukraine
facility: UA010
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.