Clinical trial NCT00658645: 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: 2008-04-15
Enrollment: 227
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 (11916A).

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: Radnevo
country: Bulgaria
facility: BG002
city: Radnevo
country: Bulgaria
facility: BG003
city: Beijing
country: China
facility: CN009
city: Beijing
country: China
facility: CN008
city: Maroussi
country: Greece
facility: GR001
city: Tripoli
country: Greece
facility: GR003
city: Brasov
country: Romania
facility: RO004
city: Bucuresti
country: Romania
facility: RO001
city: Bucuresti
country: Romania
facility: RO002
city: Bucuresti
country: Romania
facility: RO003
city: Bucuresti
country: Romania
facility: RO009
city: Iasi
country: Romania
facility: RO008
city: Pitesti
country: Romania
facility: RO005
city: Sibiu
country: Romania
facility: RO007
city: Targoviste
country: Romania
facility: RO006
city: Arkhangelsk
country: Russian Federation
facility: RU003
city: Chita
country: Russian Federation
facility: RU017
city: Moscow
country: Russian Federation
facility: RU001
city: Moscow
country: Russian Federation
facility: RU005
city: Saratov
country: Russian Federation
facility: RU002
city: St. Petersburg
country: Russian Federation
facility: RU009
city: St. Petersburg
country: Russian Federation
facility: RU013
city: St. Petersburg
country: Russian Federation
facility: RU012
city: St. Petersburg
country: Russian Federation
facility: RU011
city: St. Petersburg
country: Russian Federation
facility: RU004
city: St. Petersburg
country: Russian Federation
facility: RU010
city: St. Petersburg
country: Russian Federation
facility: RU014
city: Tomsk
country: Russian Federation
facility: RU015
city: Hualien Town
country: Taiwan
facility: TW001
city: Taipei
country: Taiwan
facility: TW003
city: Bangkok
country: Thailand
facility: TH002
city: Bangkok
country: Thailand
facility: TH001
city: Chiang Mai
country: Thailand
facility: TH003
city: Chiang Mai
country: Thailand
facility: TH004
city: Glevakha
country: Ukraine
facility: UA002
city: Kyiv
country: Ukraine
facility: UA001
city: Kyiv
country: Ukraine
facility: UA013
city: Lugansk
country: Ukraine
facility: UA012
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.