Efficacy of Bifeprunox in Patients With Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: Bifeprunox (Drug); Placebo (Drug); Quetiapine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

Overall contact:
Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com

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

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).

Secondary outcome: 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

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).

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com

RO001, Bucuresti 041914, Romania; Recruiting

RO002, Bucuresti 041914, Romania; Recruiting

RO003, Bucuresti 041914, Romania; Recruiting

RO004, Brasov 500123, Romania; Recruiting

RO005, Pitesti 110069, Romania; Recruiting

RO006, Targoviste 130081, Romania; Recruiting

RO007, Sibiu 550082, Romania; Recruiting

RU002, Saratov 410012, Russian Federation; Recruiting

RU003, Arkhangelsk 163060, Russian Federation; Recruiting

RU004, St. Petersburg 193019, Russian Federation; Recruiting

RU009, St. Petersburg 190005, Russian Federation; Recruiting

RU010, St. Petersburg 193019, Russian Federation; Recruiting

RU011, St. Petersburg 191119, Russian Federation; Recruiting

RU012, St. Petersburg 190013, Russian Federation; Recruiting

RU013, St. Petersburg 190005, Russian Federation; Recruiting

RU014, St. Petersburg 193167, Russian Federation; Recruiting

TH002, Bangkok 10330, Thailand; Recruiting

TH001, Bangkok 10600, Thailand; Recruiting

TH003, Chiang Mai 50200, Thailand; Recruiting

TH004, Chiang Mai 50200, Thailand; Recruiting

UA001, Kyiv 02660, Ukraine; Recruiting

Starting date: March 2008
Ending date: November 2010
Last updated: October 22, 2008