We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov 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.
ClinicalTrials.gov Identifier: NCT00704509
Recruitment Status : Terminated (Interim analysis showed inadequate efficacy of bifeprunox)
First Posted : June 25, 2008
Last Update Posted : September 27, 2010
Sponsor:
Information provided by:

Study Description
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 (11915A).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 346 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 : June 2008
Primary Completion Date : August 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00704509


  Show 45 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
More Information

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00704509     History of Changes
Other Study ID Numbers: 11916A
2007-001098-27 ( EudraCT Number )
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by H. Lundbeck A/S:
Schizophrenia
Antipsychotic
Bifeprunox

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs