Efficacy of Bifeprunox in Patients With Schizophrenia

This study has been terminated.
(Interim analysis showed inadequate efficacy of bifeprunox)
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00704509
First received: June 24, 2008
Last updated: September 24, 2010
Last verified: September 2010

June 24, 2008
September 24, 2010
June 2008
August 2009   (final data collection date for primary outcome 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). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00704509 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Bifeprunox
    20 mg daily, encapsulated tablets, orally, 12 months
    Other Name: DU 127090
  • Drug: Placebo
    Encapsulated tablets, orally, 12 weeks
  • Drug: Quetiapine
    600 mg daily, encapsulated tablets, orally, 12 months
    Other Name: Seroquel
  • Experimental: Bifeprunox
    Intervention: Drug: Bifeprunox
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Quetiapine
    Intervention: Drug: Quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
346
November 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Indonesia,   India,   Korea, Republic of,   Malaysia,   Philippines,   Poland,   Ukraine
 
NCT00704509
11916A, 2007-001098-27
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP