Schizophrenia
Conditions
Keywords
Schizophrenia, Antipsychotic, Bifeprunox
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).
Interventions
DRUGBifeprunox
20 mg daily, encapsulated tablets, orally, 12 months
DRUGPlacebo
Encapsulated tablets, orally, 12 weeks
DRUGQuetiapine
600 mg daily, encapsulated tablets, orally, 12 months
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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). | 12 weeks |
Secondary
| 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. | 12 months |
Countries
India, Indonesia, Malaysia, Philippines, Poland, South Korea, Ukraine
Outcome results
None listed