Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Efficacy of Bifeprunox in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658645
Recruitment Status : Terminated (Interim analysis showed inadequate efficacy of bifeprunox)
First Posted : April 15, 2008
Last Update Posted : September 27, 2010
Information provided by:
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Bifeprunox Drug: Placebo Drug: Quetiapine Phase 3

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Quetiapine

Arm Intervention/treatment
Experimental: Bifeprunox Drug: Bifeprunox
20 mg daily, encapsulated tablets, orally, 12 months
Other Name: DU 127090

Placebo Comparator: Placebo Drug: Placebo
Encapsulated tablets, orally, 12 weeks

Active Comparator: Quetiapine Drug: Quetiapine
600 mg daily, encapsulated tablets, orally, 12 months
Other Name: Seroquel

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00658645

Show Show 38 study locations
Sponsors and Collaborators
H. Lundbeck A/S
Layout table for investigator information
Study Director: Email contact via H. Lundbeck A/S

Layout table for additonal information
Responsible Party: H. Lundbeck A/S Identifier: NCT00658645    
Other Study ID Numbers: 11915A
2007-001097-90 ( EudraCT Number )
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010
Keywords provided by H. Lundbeck A/S:
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs